Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT05168267
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PTSD Treatment for Incarcerated Men and Women: NIMH
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': 'mrkoenigs@wisc.edu', 'phone': '(608) 263-1679', 'title': 'Michael Koenigs', 'organization': 'University of Wisconsin Madison - Incarceration and Mental Health Lab'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)', 'description': 'Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT)\n\nGroup = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 7, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT)\n\nGroup = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 14, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Passive Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased PTSD symptoms', 'notes': 'Nightmares, Increase in PTSD symptom on PCL-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in depressive symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Segregated Housing Placement / Rule Violation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Event', 'notes': 'Hip issue requiring crutches, carpal tunnel syndrome, nerve pain in neck, dizziness and fainting due to existing condition, bedrest for unknown illness, infected finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Social Circusmtances', 'notes': 'Family member assaulted, argument with peer, kicked out of school, legal issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks (by the end of 12th session)', 'description': 'Intervention feasibility measured primarily by participant retention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Self-reported PTSD Symptoms (PCL-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.07', 'groupId': 'OG000', 'lowerLimit': '-58', 'upperLimit': '-13'}, {'value': '-12.94', 'groupId': 'OG001', 'lowerLimit': '-43', 'upperLimit': '-12.94'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)', 'description': 'PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline and post-intervention data - the negative numbers indicate a decrease in symptom severity of the intervention period.'}, {'type': 'PRIMARY', 'title': 'Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.48', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '4.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post (1 week post-intervention, up to 13 weeks on study)', 'description': 'Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants lost to follow up'}, {'type': 'SECONDARY', 'title': 'Percentage of Individuals That Meet Study Inclusion Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline (one week prior to intervention)', 'description': 'Assesses for participant eligibility as secondary measure of intervention feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Screened participants (one week prior to intervention)'}, {'type': 'SECONDARY', 'title': 'Percentage of Eligible Individuals Enrolled in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to start of intervention', 'description': 'Assesses for participant interest as secondary measure of intervention feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Assesses for participant compliance: extent to which participants complied with treatment skill practice', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Retained participants (up to 12 weeks on study)'}, {'type': 'SECONDARY', 'title': 'Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'units': 'CPT session elements', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.72', 'groupId': 'OG000'}, {'value': '85.96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.', 'unitOfMeasure': 'Percentage of session elements present', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'CPT session elements', 'denomUnitsSelected': 'CPT session elements', 'populationDescription': 'CPT session elements'}, {'type': 'SECONDARY', 'title': 'Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'units': 'CPT session elements', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'title': 'Unique Items', 'categories': [{'measurements': [{'value': '4.67', 'spread': '.57', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'Essential Items', 'categories': [{'measurements': [{'value': '4.77', 'spread': '.43', 'groupId': 'OG000'}, {'value': '4.36', 'spread': '.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.', 'unitOfMeasure': 'CPT session elements', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'CPT session elements', 'denomUnitsSelected': 'CPT session elements', 'populationDescription': 'Both unique and non-unique but essential items were analyzed. Unique Items = therapeutic tasks specific to delivery of CPT; Essential Items = therapeutic tasks not specific to CPT but essential to the therapeutic process'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post (one week post-intervention, up to 13 weeks on study)', 'description': 'Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reasons for Participant Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'OG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'classes': [{'title': 'Transferred Facilities', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Scheduling Issues', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Group "Not Helpful"', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Work', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn by study clinician', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 month follow up (up to 25 weeks)', 'description': 'We will collect information on participant dropout reasons to understand reasons for discontinuation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'FG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Screened', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Consented to Participate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Eligible to Participate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Started Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Participants Providing Data at 1-week Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn by Therapist', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Left Facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '89 participants were consented, 79 were deemed eligible, 69 started group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Women's Facility Cognitive Processing Therapy (CPT) Group", 'description': "Arm = Cognitive Processing Therapy (CPT) Group = Women's Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups."}, {'id': 'BG001', 'title': "Men's Facility Cognitive Processing Therapy (CPT)", 'description': 'Arm = Cognitive Processing Therapy (CPT)\n\nGroup = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD\n\nCognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.09', 'spread': '10.78', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '38.12', 'spread': '11.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Womens Facility', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race was measured by facility (men \\& women)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PCL-5', 'classes': [{'categories': [{'measurements': [{'value': '50.49', 'spread': '12.29', 'groupId': 'BG000'}, {'value': '47.26', 'spread': '10.31', 'groupId': 'BG001'}, {'value': '48.90', 'spread': '11.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Anxiety Inventory (BAI)', 'classes': [{'categories': [{'measurements': [{'value': '22.57', 'spread': '9.72', 'groupId': 'BG000'}, {'value': '25.03', 'spread': '9.32', 'groupId': 'BG001'}, {'value': '23.72', 'spread': '9.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Anxiety level measured by score on BAI (between 0 to 63, over 30 = severe anxiety); to characterize our baseline sample of participants', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory 2 (BDI-II)', 'classes': [{'categories': [{'measurements': [{'value': '30.14', 'spread': '11.41', 'groupId': 'BG000'}, {'value': '29.94', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '30.04', 'spread': '10.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Depression level measured by score on BDI-II (between 0 to 63, over 40 = severe depression); to characterize the baseline sample of participants', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-22', 'size': 558953, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-02-26T11:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants are assigned to CPT therapy-intervention group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-12-08', 'resultsFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions', 'timeFrame': 'up to 6 weeks (by the end of 12th session)', 'description': 'Intervention feasibility measured primarily by participant retention'}, {'measure': 'Change in Self-reported PTSD Symptoms (PCL-5)', 'timeFrame': 'baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)', 'description': 'PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.'}, {'measure': 'Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)', 'timeFrame': 'Post (1 week post-intervention, up to 13 weeks on study)', 'description': 'Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Individuals That Meet Study Inclusion Criteria', 'timeFrame': 'baseline (one week prior to intervention)', 'description': 'Assesses for participant eligibility as secondary measure of intervention feasibility.'}, {'measure': 'Percentage of Eligible Individuals Enrolled in the Study', 'timeFrame': 'up to start of intervention', 'description': 'Assesses for participant interest as secondary measure of intervention feasibility.'}, {'measure': 'Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.'}, {'measure': 'Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Assesses for participant compliance: extent to which participants complied with treatment skill practice'}, {'measure': 'Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.'}, {'measure': 'Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist', 'timeFrame': 'By the end of final treatment session (up to 12 weeks)', 'description': 'Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.'}, {'measure': 'Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)', 'timeFrame': 'post (one week post-intervention, up to 13 weeks on study)', 'description': 'Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility.'}, {'measure': 'Reasons for Participant Discontinuation', 'timeFrame': 'Up to 3 month follow up (up to 25 weeks)', 'description': 'We will collect information on participant dropout reasons to understand reasons for discontinuation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Group therapy', 'Incarcerated Individuals'], 'conditions': ['PTSD']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'James, D.J. and L.E. Glaze, Mental health problems of prison and jail inmates, U.S.D.o. Justice, Editor. 2006: Bureau of Justice Statistics Special Report.'}, {'pmid': '25757522', 'type': 'BACKGROUND', 'citation': "Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209."}, {'pmid': '25697197', 'type': 'BACKGROUND', 'citation': 'Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20.'}, {'type': 'BACKGROUND', 'citation': 'Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.'}, {'pmid': '12182270', 'type': 'BACKGROUND', 'citation': 'Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.'}, {'pmid': '12150085', 'type': 'BACKGROUND', 'citation': 'Morgan RD, Winterowd CL. Interpersonal process-oriented group psychotherapy with offender populations. Int J Offender Ther Comp Criminol. 2002 Aug;46(4):466-82. doi: 10.1177/0306624X02464008.'}]}, 'descriptionModule': {'briefSummary': 'Study examining the feasibility of and psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.', 'detailedDescription': 'Overall Study Objectives:\n\nThe primary objectives of this project include:\n\n1. Establish the feasibility of group CPT delivery in male and female incarcerated populations with PTSD;\n2. Establish the acceptability of group CPT delivery in male and female incarcerated populations with PTSD;\n3. Establish feasibility of assessment collection for primary outcome measures, secondary outcome measures, and potential mediators and moderators during a clinical trial examining group CPT delivery in incarcerated settings.\n\nPrior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.\n\nPotential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.\n\nEligible participants will first complete the Clinician-Administered PTSD Scale for DSM-5 (PCL-5) to ascertain current PTSD symptomology and diagnosis. Participants will then be assigned to the CPT groups. The CPT groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 6 participants will be included in each CPT session. Participants will be notified via institutional mail when they are starting CPT. Participants will be able to continue any ongoing treatment/interventions they are engaged in within the institution. All participants will be asked what treatment groups they are currently enrolled in during the initial screening to examine the possibility of attentional bias within the CPT group (i.e., more frequent interaction leading to treatment outcomes).\n\nIn addition to the treatment groups, CPT group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. After treatment session 5, group members will complete mid-testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT group members will then complete post-treatment testing within one week after completing treatment (group session 12). One month after the treatment is completed, group members will complete the first round of follow-up testing. Three months after the treatment is completed, group members will complete the final round of follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. The three month follow-up session will be identical, with the addition of the PCL-5 interview to re-assess PTSD diagnosis. Group members will be asked to complete 18 sessions in total (pre-, mid-, post-, one-month follow-up testing, three month follow-up testing, 12 treatment groups, and 1 post-intervention focus group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Intelligence quotient (IQ) greater than or equal to 70\n* 18 years old or older\n* Reading level of 4th grade or higher\n* stable medication use (same medication for at least one month)\n* able and willing to participate in group therapy\n* meet PCL-5 criteria for a current PTSD diagnosis within two months of study enrollment\n* no scheduled release date before the end of the treatment group\n\nExclusion Criteria:\n\n* currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself\n* no active symptoms of psychosis that would interfere with the individual's ability to participate in the group\n* no active suicidal ideation with intent or plan"}, 'identificationModule': {'nctId': 'NCT05168267', 'briefTitle': 'PTSD Treatment for Incarcerated Men and Women: NIMH', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'PTSD Treatment for Incarcerated Men and Women: NIMH', 'orgStudyIdInfo': {'id': '2018-0630: NIMH'}, 'secondaryIdInfos': [{'id': 'R34MH118319', 'link': 'https://reporter.nih.gov/quickSearch/R34MH118319', 'type': 'NIH'}, {'id': 'A538900', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Processing Therapy (CPT) group', 'description': 'Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) receive CPT to treat PTSD', 'interventionNames': ['Behavioral: Cognitive Processing Therapy']}], 'interventions': [{'name': 'Cognitive Processing Therapy', 'type': 'BEHAVIORAL', 'description': 'CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups.', 'armGroupLabels': ['Cognitive Processing Therapy (CPT) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Psychiatric Institute and Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Michael R Koenigs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}