Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 8:05 PM
Study NCT ID:
NCT01928732
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness Research in Veterans With PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lisa.Zehm@va.gov', 'phone': '(650) 493-5000', 'title': 'Lisa Zehm', 'phoneExt': '28805', 'organization': 'Palo Alto CSPCC'}, 'certainAgreement': {'otherDetails': "The presentation or publication of any data collected by investigators on participants entered into the VA cooperative study is under the control of the study's Executive Committee. No individual participating investigator is permitted to perform analyses or interpretations or to make public presentations or seek publication of any of the data other than under the auspices and approval of the Executive Committee.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 12 months', 'description': 'Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.', 'otherNumAtRisk': 455, 'deathsNumAtRisk': 455, 'otherNumAffected': 42, 'seriousNumAtRisk': 455, 'deathsNumAffected': 1, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.', 'otherNumAtRisk': 461, 'deathsNumAtRisk': 461, 'otherNumAffected': 65, 'seriousNumAtRisk': 461, 'deathsNumAffected': 2, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcohol Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Attention deficit/hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Burglary Victim', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death of Companion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death of Relative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disturbance in Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug Administration Error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug screen positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug Use Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Electric Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Emotional Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Exaggerated startle response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Facial Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flashback', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Homeless', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Homicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypervigilance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Impaired Driving Ability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Imprisonment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intentional Self-Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intrusive Thoughts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Legal Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Loss of Employment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Marital Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post-traumatic Stress Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rotator Cuff Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Shoplifting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sick Relative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stress', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Therapy Cessation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 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1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 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poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Localized Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neck Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Organic erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Panic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngeal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post-Procedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post Procedural Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostatic operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Scar excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Snake Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal Fusion Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tendon Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Violence-related symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '25.2'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '28.9'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '27.8'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '30.2'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '26.2'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '28.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.65', 'estimateComment': 'Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)', 'groupDescription': 'Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.74', 'estimateComment': 'Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)', 'groupDescription': 'Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.24', 'ciUpperLimit': '2.00', 'estimateComment': 'Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)', 'groupDescription': 'Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Diagnostic Scale (PDS-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '35.6'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '34.7', 'upperLimit': '38.7'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '36.4'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '39.4'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '35.5'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '38.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The PDS-5 is a 24-item self-report measure that assesses PTSD symptom severity in the last month according to DSM-5 criteria. The outcome is the change of PDS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '23.5'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '24.1'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '23.5'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '22.3', 'upperLimit': '24.9'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '23.3'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'BDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology. The outcome is the change of BDI-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spielberger State Anger Inventory (STAXI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '95.4'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '96.5'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '95.3'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '92.8', 'upperLimit': '96.6'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '95.4'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '92.6', 'upperLimit': '96.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The STAXI is a commonly used measure of trait and state anxiety. The outcome is the change of STAI total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for STAXI 44-176. Higher score indicates greater intensity of anger.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Inventory of Problems - Revised (SIP-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '3.34'}, {'value': '2.49', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '3.23'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '1.58', 'upperLimit': '3.25'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '2.97'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '2.22', 'upperLimit': '3.95'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '2.51'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The SIP-R assesses alcohol-related consequences. The outcome is the change of SIP-R total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Addiction Monitor (BAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.03'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.02'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.16'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.1'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.11'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.97'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': "The BAM measures an individual's health, alcohol, and drug use. The outcome is the change of BAM total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'World Health Organization Disability Assessment Schedule (WHO-DAS-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '29.4'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '29.4'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '29.0'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '27.7', 'upperLimit': '29.7'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '29.4'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': '29.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The WHO-DAS-II is an assessment instrument for health and disability. The outcome is the change of WHO-DAS-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life (WHOQoL-BREF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'OG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'classes': [{'title': 'Physical Health - Posttreatment', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000', 'lowerLimit': '44.5', 'upperLimit': '49.5'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '51.1'}]}]}, {'title': 'Physical Health - 3 Months', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000', 'lowerLimit': '45.7', 'upperLimit': '48.2'}, {'value': '47.0', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '48.2'}]}]}, {'title': 'Physical Health - 6 Months', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '48.4'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '45.6', 'upperLimit': '48.2'}]}]}, {'title': 'Psychological - Posttreatment', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '50.5'}, {'value': '48.9', 'groupId': 'OG001', 'lowerLimit': '47.3', 'upperLimit': '50.5'}]}]}, {'title': 'Psychological - 3 Months', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '50.5'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '46.7', 'upperLimit': '49.4'}]}]}, {'title': 'Psychological - 6 Months', 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '51.1'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '50.7'}]}]}, {'title': 'Social Relationship - Posttreatment', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '43.1', 'upperLimit': '47.8'}, {'value': '43.9', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '46.3'}]}]}, {'title': 'Social Relationship - 3 Months', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '48.8'}, {'value': '44.1', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '46.6'}]}]}, {'title': 'Social Relationship - 6 Months', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '48.6'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '48.2'}]}]}, {'title': 'Environment - Posttreatment', 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '62.9'}, {'value': '59.5', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '61.3'}]}]}, {'title': 'Environment - 3 Months', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '63.2'}, {'value': '59.8', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '61.4'}]}]}, {'title': 'Environment - 6 Months', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '64.1'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '59.2', 'upperLimit': '62.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The WHOQoL-BREF is a quality of life assessment. The outcome is the change of WHOQoL-BREF assessment sub-category (Physical Health, Psychological, Social Relationships, Environment) scores from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'FG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '455'}, {'groupId': 'FG001', 'numSubjects': '461'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '334'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '127'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral: Prolonged Exposure (PE)', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.'}, {'id': 'BG001', 'title': 'Behavioral: Cognitive Processing Therapy (CPT)', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'BG000', 'lowerLimit': '44.3', 'upperLimit': '46.8'}, {'value': '44.9', 'groupId': 'BG001', 'lowerLimit': '43.7', 'upperLimit': '46.1'}, {'value': '45.2', 'groupId': 'BG002', 'lowerLimit': '44.3', 'upperLimit': '46.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaskan Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants could select multiple categories for "Race."', 'unitOfMeasure': 'Participants'}, {'title': 'Service Era', 'classes': [{'title': 'Vietnam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}, {'title': 'Gulf War', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'OEF/OIF/OND', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Service era was coded by including any Vietnam, Gulf, or OEF/OIF/OND veteran in their respective categories (including if they served in more than one era, e.g., Vietnam and Gulf). If a veteran did not serve in Vietnam, Gulf, or OEF/OIF/OND, they were coded as "Other."', 'unitOfMeasure': 'Participants'}, {'title': 'Post-high school education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Unemployed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Married/cohabitating', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity: Spanish, Hispanic or Latino', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive VA Military Sexual Trauma Screen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive VA Traumatic Brain Injury Screen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '575', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime trauma exposure: Number of event types (of 17)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'BG000', 'lowerLimit': '7.4', 'upperLimit': '7.9'}, {'value': '7.4', 'groupId': 'BG001', 'lowerLimit': '7.2', 'upperLimit': '7.7'}, {'value': '7.54', 'groupId': 'BG002', 'lowerLimit': '7.4', 'upperLimit': '7.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of event types', 'dispersionType': 'FULL_RANGE'}, {'title': 'Lifetime trauma exposure', 'classes': [{'title': 'Combat exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '347', 'groupId': 'BG001'}, {'value': '704', 'groupId': 'BG002'}]}]}, {'title': 'Any sexual trauma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}]}, {'title': 'Physical assault', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '408', 'groupId': 'BG001'}, {'value': '794', 'groupId': 'BG002'}]}]}, {'title': 'Disaster exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}]}, {'title': 'Serious accident', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '774', 'groupId': 'BG002'}]}]}, {'title': 'Life-threatening illness or injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}]}, {'title': 'Other traumatic event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PTSD disability', 'classes': [{'title': 'Approved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '912', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}, {'title': 'Pending', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '912', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}, {'title': 'Denied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '912', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Never applied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '912', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.'}, {'title': 'Receiving psychotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Taking psychotropic medication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any current comorbid psychiatric disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '714', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any current comorbid psychiatric disorder', 'classes': [{'title': 'Mood disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '641', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}, {'title': 'Substance use disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Obsessive compulsive disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any lifetime comorbid psychiatric disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '417', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '841', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any lifetime comorbid psychiatric disorder', 'classes': [{'title': 'Mood disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '798', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}, {'title': 'Substance use disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}, {'title': 'Obsessive compulsive disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinician Administered PTSD Scale-5', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'BG000', 'lowerLimit': '39.1', 'upperLimit': '40.7'}, {'value': '40.3', 'groupId': 'BG001', 'lowerLimit': '39.5', 'upperLimit': '41.1'}, {'value': '40.1', 'groupId': 'BG002', 'lowerLimit': '39.6', 'upperLimit': '40.7'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Posttraumatic Diagnostic Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'BG000', 'lowerLimit': '49.5', 'upperLimit': '52.0'}, {'value': '50.5', 'groupId': 'BG001', 'lowerLimit': '49.3', 'upperLimit': '51.7'}, {'value': '50.63', 'groupId': 'BG002', 'lowerLimit': '49.8', 'upperLimit': '51.5'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Beck Depression Inventory-II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '29.4', 'upperLimit': '31.3'}, {'value': '30.0', 'groupId': 'BG001', 'lowerLimit': '29.0', 'upperLimit': '30.9'}, {'value': '30.2', 'groupId': 'BG002', 'lowerLimit': '29.5', 'upperLimit': '30.8'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Beck Depression Inventory-II Suicidality (BDI-II Item 9)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Suicidality was coded by grouping "I have thoughts of killing myself, but I would not carry them out" "I would like to kill myself" and "I would kill myself if I had the chance" from item 9 of the BDI-II together as endorsing suicidality. Unit of measure is the #/% of participants who endorsed suicidality using this coding metric.', 'unitOfMeasure': 'Participants'}, {'title': 'Spielberger Trait Anger Expression Inventory', 'classes': [{'title': 'State Anger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'BG000', 'lowerLimit': '17.1', 'upperLimit': '18.5'}, {'value': '17.9', 'groupId': 'BG001', 'lowerLimit': '17.3', 'upperLimit': '18.6'}, {'value': '17.9', 'groupId': 'BG002', 'lowerLimit': '17.4', 'upperLimit': '18.3'}]}]}, {'title': 'Trait Anger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'BG000', 'lowerLimit': '23.5', 'upperLimit': '24.8'}, {'value': '24.2', 'groupId': 'BG001', 'lowerLimit': '23.6', 'upperLimit': '24.8'}, {'value': '24.2', 'groupId': 'BG002', 'lowerLimit': '23.7', 'upperLimit': '24.6'}]}]}, {'title': 'Anger Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'BG000', 'lowerLimit': '36.3', 'upperLimit': '38.3'}, {'value': '36.4', 'groupId': 'BG001', 'lowerLimit': '35.5', 'upperLimit': '37.4'}, {'value': '36.9', 'groupId': 'BG002', 'lowerLimit': '36.2', 'upperLimit': '37.5'}]}]}], 'paramType': 'MEAN', 'description': 'Subscale Ranges: State Anger 10-40, Trait Anger 10-40, Anger Expression 0-72. Higher score indicates more anger', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Brief Addiction Monitor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000', 'lowerLimit': '0.6', 'upperLimit': '0.9'}, {'value': '0.8', 'groupId': 'BG001', 'lowerLimit': '0.7', 'upperLimit': '0.9'}, {'value': '0.8', 'groupId': 'BG002', 'lowerLimit': '0.7', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEAN', 'description': 'Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Short Inventory of Problems-Revised', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '2.7', 'upperLimit': '4.3'}, {'value': '3.3', 'groupId': 'BG001', 'lowerLimit': '2.5', 'upperLimit': '4.1'}, {'value': '3.4', 'groupId': 'BG002', 'lowerLimit': '2.9', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'World Health Organization Disability Adjustment Scale-II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'BG000', 'lowerLimit': '28.6', 'upperLimit': '30.3'}, {'value': '29.7', 'groupId': 'BG001', 'lowerLimit': '28.9', 'upperLimit': '30.5'}, {'value': '29.6', 'groupId': 'BG002', 'lowerLimit': '29.0', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'World Health Organization Quality of Life-BREF', 'classes': [{'title': 'Physical Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'BG000', 'lowerLimit': '43.4', 'upperLimit': '45.3'}, {'value': '43.7', 'groupId': 'BG001', 'lowerLimit': '42.7', 'upperLimit': '44.7'}, {'value': '44.1', 'groupId': 'BG002', 'lowerLimit': '43.4', 'upperLimit': '44.8'}]}]}, {'title': 'Psychological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'BG000', 'lowerLimit': '45.2', 'upperLimit': '47.8'}, {'value': '46.4', 'groupId': 'BG001', 'lowerLimit': '45.2', 'upperLimit': '47.7'}, {'value': '46.5', 'groupId': 'BG002', 'lowerLimit': '45.6', 'upperLimit': '47.4'}]}]}, {'title': 'Social Relationships', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'BG000', 'lowerLimit': '39.4', 'upperLimit': '43.3'}, {'value': '40.6', 'groupId': 'BG001', 'lowerLimit': '38.7', 'upperLimit': '42.5'}, {'value': '41.0', 'groupId': 'BG002', 'lowerLimit': '39.6', 'upperLimit': '42.3'}]}]}, {'title': 'Environment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.2', 'groupId': 'BG000', 'lowerLimit': '56.6', 'upperLimit': '59.7'}, {'value': '57.4', 'groupId': 'BG001', 'lowerLimit': '55.9', 'upperLimit': '59.0'}, {'value': '57.8', 'groupId': 'BG002', 'lowerLimit': '56.7', 'upperLimit': '58.9'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of patients preferring PE treatment at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '916', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treatment preference was assessed at baseline (before any treatment was administered, and before randomization to treatment arm had occurred). This measure is reported as the number of patients who reported a preference for PE as opposed to CPT. All unreported patients reported a preference for CPT (i.e., "no preference" was not a response option and no patients declined to answer).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-16', 'size': 1659344, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-07T12:39', 'hasProtocol': True}, {'date': '2014-04-15', 'size': 370207, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-07T13:14', 'hasProtocol': False}, {'date': '2017-10-13', 'size': 369346, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-07T14:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 916}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2013-08-16', 'resultsFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-21', 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.'}], 'secondaryOutcomes': [{'measure': 'Posttraumatic Diagnostic Scale (PDS-5)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The PDS-5 is a 24-item self-report measure that assesses PTSD symptom severity in the last month according to DSM-5 criteria. The outcome is the change of PDS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'BDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology. The outcome is the change of BDI-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).'}, {'measure': 'Spielberger State Anger Inventory (STAXI)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The STAXI is a commonly used measure of trait and state anxiety. The outcome is the change of STAI total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for STAXI 44-176. Higher score indicates greater intensity of anger.'}, {'measure': 'Short Inventory of Problems - Revised (SIP-R)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The SIP-R assesses alcohol-related consequences. The outcome is the change of SIP-R total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.'}, {'measure': 'Brief Addiction Monitor (BAM)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': "The BAM measures an individual's health, alcohol, and drug use. The outcome is the change of BAM total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction)."}, {'measure': 'World Health Organization Disability Assessment Schedule (WHO-DAS-II)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The WHO-DAS-II is an assessment instrument for health and disability. The outcome is the change of WHO-DAS-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.'}, {'measure': 'World Health Organization Quality of Life (WHOQoL-BREF)', 'timeFrame': 'immediate post-treatment, 3 and 6 months', 'description': 'The WHOQoL-BREF is a quality of life assessment. The outcome is the change of WHOQoL-BREF assessment sub-category (Physical Health, Psychological, Social Relationships, Environment) scores from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '30962124', 'type': 'BACKGROUND', 'citation': 'Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84]. Contemp Clin Trials. 2019 May;80:61. doi: 10.1016/j.cct.2019.04.003. Epub 2019 Apr 5. No abstract available.'}, {'pmid': '25457792', 'type': 'BACKGROUND', 'citation': 'Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD. Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29.'}, {'pmid': '35044471', 'type': 'RESULT', 'citation': 'Schnurr PP, Chard KM, Ruzek JI, Chow BK, Resick PA, Foa EB, Marx BP, Friedman MJ, Bovin MJ, Caudle KL, Castillo D, Curry KT, Hollifield M, Huang GD, Chee CL, Astin MC, Dickstein B, Renner K, Clancy CP, Collie C, Maieritsch K, Bailey S, Thompson K, Messina M, Franklin L, Lindley S, Kattar K, Luedtke B, Romesser J, McQuaid J, Sylvers P, Varkovitzky R, Davis L, MacVicar D, Shih MC. Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2136921. doi: 10.1001/jamanetworkopen.2021.36921.'}, {'pmid': '38546622', 'type': 'DERIVED', 'citation': 'Moshier SJ, Mahoney CT, Bovin MJ, Marx BP, Schnurr PP. Session-level effects of cognitive processing therapy and prolonged exposure on individual symptoms of posttraumatic stress disorder among U.S. veterans. J Consult Clin Psychol. 2024 Jul;92(7):422-431. doi: 10.1037/ccp0000880. Epub 2024 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), for treating posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about the effectiveness of these treatments compared with one another.\n\nThe sample will include 900 male and female Veterans with PTSD due to any traumatic military event. Veterans who are eligible and agree to participate in the study will be randomly assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The standard "dose" of treatment is 12 weekly sessions but Veterans who improve more rapidly may finish in fewer sessions and Veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be measured at regular follow-up visits that will occur at the middle and at the end of treatment and then 3 and 6 months later. The investigators will measure other outcomes, including additional mental health problems, functioning, quality of life, and use of treatments for mental and physical problems. The investigators also will measure Veterans\' treatment preference and examine whether Veterans who get the treatment they prefer do better than Veterans who get the less-preferred treatment.\n\nAs a large multi-site trial with men and women, CSP #591 is designed to provide conclusive information about whether one treatment is better than the other, overall and for different types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients will have more information to help them make an informed decisions about which treatment to choose and VA will have stronger evidence to help make care Veteran-centered.', 'detailedDescription': 'VA Cooperative Study CSP #591 is designed to compare the effectiveness of Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) for treating posttraumatic stress disorder (PTSD) in male and female Veterans. PTSD is a serious and prevalent condition in Veterans, affecting just under 9% of VA patients in Fiscal Year 2011 (FY11). Since 2005, the number of VA patients with PTSD has increased 14.8% annually, due not only to new Veterans but also to increased numbers of Vietnam Veterans who are seeking care. In FY11, PTSD was the 3rd most common service-connected disability in VA.\n\nDespite solid evidence that Prolonged Exposure and Cognitive Processing Therapy are effective treatments for PTSD in Veterans and non-Veterans, there is insufficient evidence about the effectiveness of these treatments relative to one another. The only study to compare the treatments, a single-site trial in non-Veteran female rape survivors, failed to find a difference, but the study was not adequately powered to compare two such effective treatments. Other data are similarly inconclusive. CSP #591 would break new ground as the first large-scale comparative effectiveness trial of treatment for PTSD and the first study to provide definitive information about how effective treatments for PTSD compare with one another.\n\nThe study will be a prospective randomized clinical trial with blinded assessment. The population will be male and female Veterans with PTSD due to any traumatic military event. Patients who are eligible and agree to participate in the study will be randomly assigned in a 1:1 ratio to receive Prolonged Exposure or Cognitive Processing Therapy. The investigators propose to administer 12 weekly sessions of each treatment as a standard "dose" but to allow participants who improve more rapidly to finish in 10 or 11 sessions and participants who have not attained adequate improvement by session 12 to have up to 2 additional sessions.\n\nThe primary outcome is improvement in PTSD symptom severity as measured by change on the Clinician-Administered PTSD Scale after treatment. The outcome measure will be determined from regular follow-up visits of the patients, which will occur at the middle and at the end of treatment and then 3 and 6 months later. Secondary outcomes include other measures of PTSD, comorbid mental health problems, functioning, quality of life, and service utilization. The investigators also will measure participants\' treatment preference and examine whether concordance between preference and allocation is associated with increased treatment effectiveness.\n\nIn order to detect a standardized mean difference in improvement in PTSD symptom severity of d = .25, a sample size of 900 randomized patients provides 90% power to detect a difference between arms using the linear mixed effects model with a two-sided = .05. Given the lack of conclusive findings to predict which treatment is better, the investigators propose to test a nondirectional hypothesis. Assuming 2.5 years of accrual and an enrollment of 26 participants per year at each site, the investigators would need 14.1 sites to enroll a total of 64 participants per site. The investigators propose to recruit 17 sites to guard against the possibility that some sites will not enroll the required number of participants.\n\nVA has a vested interest in understanding the relative effectiveness of Prolonged Exposure and Cognitive Processing Therapy. Both treatments are recommended at the highest level in the Veterans Affairs (VA)/Department of Defense (DoD) PTSD Practice Guideline. VA is required to make these treatments available to Veterans seeking PTSD care. The treatments are being disseminated nationally across the VA system in order to enhance the availability of evidence-based treatments to Veterans with PTSD. VA also has developed a national PTSD Mentoring Program for PTSD Program Administrators to help them manage their clinics to permit the delivery of these treatments. Every facility has an evidence-based therapy coordinator as well to facilitate training in evidence-based psychotherapy.\n\nAs a large multi-site trial with men and women, CSP #591 would provide definitive information about the comparative effectiveness of Prolonged Exposure and Cognitive Processing Therapy and maximize the study\'s impact on the field. Because the treatments are based on differing theories about the development of PTSD, a demonstration that one treatment is superior to the other would further scientific exploration by challenging theoretical accounts of etiology and treatment. Regardless of which treatment is better, patients would have more information to help them make an informed decision about which treatment to choose and VA would have stronger evidence to help make care Veteran-centered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCurrent PTSD and symptom severity of 25 or higher on the Clinician- Administered PTSD Scale (Weathers et al., 2013); agreement to not receive psychotherapy for PTSD during study treatment and allow digital recording of phone interviews and therapy; regular access to a telephone (or agreement to come to the VA for centrally conducted telephone interviews for participant who do not have telephone access). Medication for PTSD and other mental or physical conditions, psychotherapy for other problems, brief visits with an existing therapist, and self-help groups will be allowed.\n\nExclusion Criteria:\n\n* substance dependence not in remission for at least 1 month;\n* current psychotic symptoms and mania (including manic phase of bipolar disorder);\n* significant current suicidal or homicidal ideation that includes a specific plan;\n* or moderate to severe cognitive impairment defined as 1 SD below age-graded norms on the Montreal Cognitive Assessment.'}, 'identificationModule': {'nctId': 'NCT01928732', 'acronym': 'CERV-PTSD', 'briefTitle': 'Comparative Effectiveness Research in Veterans With PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD', 'orgStudyIdInfo': {'id': '591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPT', 'description': 'Cognitive Processing Therapy (CPT) - a type of cognitive therapy for treating PTSD.', 'interventionNames': ['Behavioral: Cognitive Processing Therapy (CPT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PE', 'description': 'Prolonged Exposure (PE) - a type of exposure therapy for treating PTSD.', 'interventionNames': ['Behavioral: Prolonged Exposure (PE)']}], 'interventions': [{'name': 'Cognitive Processing Therapy (CPT)', 'type': 'BEHAVIORAL', 'description': 'CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.', 'armGroupLabels': ['CPT']}, {'name': 'Prolonged Exposure (PE)', 'type': 'BEHAVIORAL', 'description': 'PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.', 'armGroupLabels': ['PE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Tuscaloosa VA Medical Center, Tuscaloosa, AL', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System, Phoenix, AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System, Long Beach, CA', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center, San Francisco, CA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur, GA', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. VA Hospital, Hines, IL', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southeast Louisiana Veterans Health Care System, New Orleans, LA', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '87108-5153', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System, Albuquerque, NM', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati VA Medical Center, Cincinnati, OH', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City, UT', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05009-0001', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'White River Junction VA Medical Center, White River Junction, VT', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'William S. Middleton Memorial Veterans Hospital, Madison, WI', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Paula P Schnurr, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'White River Junction VA Medical Center, White River Junction, VT'}, {'name': 'Josef I Ruzek, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA'}, {'name': 'Kathleen M Chard, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cincinnati VA Medical Center, Cincinnati, OH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}