Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT01574118
Status:
TERMINATED
Last Update Posted:
2022-08-29
First Post:
2012-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhancing Exposure Therapy for Post-traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'COVID-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PTSD symptom severity', 'timeFrame': 'Weeks 6, 10, 22', 'description': 'PTSD Symptom Scale - Interview Version'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in depression symptom severity', 'timeFrame': 'Weeks 6, 10, 22.', 'description': 'Quick Inventory of Depressive Symptomatology - Self-Report'}, {'measure': 'Change from baseline in trauma-related cognitions', 'timeFrame': 'Weeks 6, 10, 22.', 'description': 'Post-Traumatic Cognitions Inventory - Self-Report'}, {'measure': 'Change from baseline in general physical and psychological health', 'timeFrame': 'Weeks 6, 10, 22', 'description': 'Medical Outcomes Study Short Form 36, Version 2 - Self-report'}, {'measure': 'Change from baseline in work, social/leisure activities, and family/home life functioning', 'timeFrame': 'Weeks 6, 10, 22.', 'description': 'Sheehan Disability Scale - Self-report'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Posttraumatic Stress Disorder', 'Exposure Therapy', 'Prolonged Exposure', 'Fear Memory Retrieval', 'Compound extinction', 'Deepened extinction', 'Psychotherapy'], 'conditions': ['Chronic Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.', 'detailedDescription': 'This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.\n2. Between the age of 18 and 65.\n3. Medication status stable for at least 6 weeks\n\nExclusion Criteria:\n\n1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.\n2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).\n3. Current diagnosis of alcohol or substance dependence within the 3 previous months.\n4. Unwilling or unable to discontinue current trauma-focused psychotherapy.\n5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).\n6. Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.'}, 'identificationModule': {'nctId': 'NCT01574118', 'briefTitle': 'Enhancing Exposure Therapy for Post-traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies', 'orgStudyIdInfo': {'id': '2012-02-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Enhanaced Exposure Therapy', 'description': "The following interventions are included in this arm:\n\n1. Psycho-education addressing common reactions to trauma\n2. Revisiting the Trauma memories\n3. Processing the trauma memories\n4. In vivo Exposure homework\n5. \\*Use of a brief pre-exposure trauma memory retrieval trial\n6. Exposure to video clips related to the patient's trauma\n7. Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script", 'interventionNames': ['Behavioral: Revisiting the Trauma memories', 'Behavioral: Processing the trauma memories', 'Behavioral: Psychoeducation', 'Behavioral: Trauma Memory Retrieval Trial', "Behavioral: Exposure to video clips related to the patient's trauma", 'Behavioral: Exposure Homework', 'Behavioral: Compound extinction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Prolonged Exposure Therapy', 'description': 'The following interventions are included in this arm:\n\n1. Psycho-education addressing common reactions to trauma\n2. Revisiting of the Trauma memories\n3. Processing the trauma memories\n4. Breathing retraining\n5. In vivo Exposure homework', 'interventionNames': ['Behavioral: Revisiting the Trauma memories', 'Behavioral: Processing the trauma memories', 'Behavioral: Psychoeducation', 'Behavioral: Breathing retraining', 'Behavioral: Exposure Homework']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed Treatment Control', 'description': 'Patients assigned to this arm receive assessment only (Week 0, 3, and 6) prior to receiving standard prolonged exposure therapy using the Foa et al treatment manual.'}], 'interventions': [{'name': 'Revisiting the Trauma memories', 'type': 'BEHAVIORAL', 'otherNames': ['Trauma Revisiting'], 'description': 'Patient engages in repeated revisiting of their trauma memory under the guidance of the therapist for about 40 minutes. During each revisiting trial the patient closes their eyes and verbally describes the trauma and the feeling and thoughts experienced during the trauma.', 'armGroupLabels': ['Brief Enhanaced Exposure Therapy', 'Standard Prolonged Exposure Therapy']}, {'name': 'Processing the trauma memories', 'type': 'BEHAVIORAL', 'otherNames': ['Trauma Processing'], 'description': "The patient and therapist discuss the patient's experience during the trauma revisiting with the goal of helping the patient gain alternative perspectives of the trauma.", 'armGroupLabels': ['Brief Enhanaced Exposure Therapy', 'Standard Prolonged Exposure Therapy']}, {'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.', 'armGroupLabels': ['Brief Enhanaced Exposure Therapy', 'Standard Prolonged Exposure Therapy']}, {'name': 'Trauma Memory Retrieval Trial', 'type': 'BEHAVIORAL', 'otherNames': ['Fear Retrieval'], 'description': 'Prior to the start of Imaginal Exposure, the patient is asked to recall a threatening element of their trauma memory for 1 minute. This is followed by a 30-minute rest-period prior to beginning imaginal exposure.', 'armGroupLabels': ['Brief Enhanaced Exposure Therapy']}, {'name': "Exposure to video clips related to the patient's trauma", 'type': 'BEHAVIORAL', 'otherNames': ['Exposure to trauma clips'], 'description': "Patient is seated in front of a computer monitor and instructed to view a 30-min looped video clip that thematically resembles the patient's trauma.", 'armGroupLabels': ['Brief Enhanaced Exposure Therapy']}, {'name': 'Breathing retraining', 'type': 'BEHAVIORAL', 'otherNames': ['Relaxed breathing'], 'description': 'Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.', 'armGroupLabels': ['Standard Prolonged Exposure Therapy']}, {'name': 'Exposure Homework', 'type': 'BEHAVIORAL', 'otherNames': ['In vivo exposure outside of session'], 'description': 'Therapist assists the patient in identifying trauma-related situations/activities that the patient is avoiding and encourages the patient to begin to confront these situations between sessions.', 'armGroupLabels': ['Brief Enhanaced Exposure Therapy', 'Standard Prolonged Exposure Therapy']}, {'name': 'Compound extinction', 'type': 'BEHAVIORAL', 'otherNames': ['Deepened Extinction'], 'description': 'The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.', 'armGroupLabels': ['Brief Enhanaced Exposure Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Laboratory for the Study of Anxiety Disorders, University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Michael J Telch, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael J. Telch', 'investigatorAffiliation': 'University of Texas at Austin'}}}}