Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-03 @ 6:20 AM
Study NCT ID:
NCT02173561
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)', 'timeFrame': 'Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up', 'description': 'PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II', 'timeFrame': 'Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up', 'description': 'The BDI-II is one of the most widely used instruments for measuring the severity of depressive symptoms. It consists of 21 items that assess both affective and somatic symptoms related to depression and depressive disorders. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance). Scores on all items are summed to obtain a total severity score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Posttraumatic Stress Disorder', 'Cognitive Processing Therapy', 'combat', 'military', 'CPT', 'group therapy'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '27893032', 'type': 'RESULT', 'citation': 'Resick PA, Wachen JS, Dondanville KA, Pruiksma KE, Yarvis JS, Peterson AL, Mintz J; and the STRONG STAR Consortium; Borah EV, Brundige A, Hembree EA, Litz BT, Roache JD, Young-McCaughan S. Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):28-36. doi: 10.1001/jamapsychiatry.2016.2729.'}, {'pmid': '36988304', 'type': 'DERIVED', 'citation': 'Pruiksma KE, Taylor DJ, Wachen JS, Straud CL, Hale WJ, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Resick PA. Self-reported sleep problems in active-duty US Army personnel receiving posttraumatic stress disorder treatment in group or individual formats: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2023 Aug 1;19(8):1389-1398. doi: 10.5664/jcsm.10584.'}, {'pmid': '36039506', 'type': 'DERIVED', 'citation': 'Wachen JS, Mintz J, LoSavio ST, Kennedy JE, Hale WJ, Straud CL, Dondanville KA, Moring J, Blankenship AE, Vandiver R, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. The impact of prior head injury on outcomes following group and individual cognitive processing therapy among military personnel. J Trauma Stress. 2022 Dec;35(6):1684-1695. doi: 10.1002/jts.22870. Epub 2022 Aug 29.'}, {'pmid': '35901423', 'type': 'DERIVED', 'citation': 'Miles SR, Hale WJ, Mintz J, Wachen JS, Litz BT, Dondanville KA, Yarvis JS, Hembree EA, Young-McCaughan S, Peterson AL, Resick PA. Hyperarousal symptoms linger after successful PTSD treatment in active duty military. Psychol Trauma. 2023 Nov;15(8):1398-1405. doi: 10.1037/tra0001292. Epub 2022 Jul 28.'}, {'pmid': '33078467', 'type': 'DERIVED', 'citation': 'Straud CL, Dondanville KA, Hale WJ, Wachen JS, Mintz J, Litz BT, Roache JD, Yarvis JS, Young-McCaughan S, Peterson AL, Resick PA; STRONG STAR Consortium. The Impact of Hazardous Drinking Among Active Duty Military With Posttraumatic Stress Disorder: Does Cognitive Processing Therapy Format Matter? J Trauma Stress. 2021 Feb;34(1):210-220. doi: 10.1002/jts.22609. Epub 2020 Oct 19.'}], 'seeAlsoLinks': [{'url': 'http://www.strongstar.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.', 'detailedDescription': "Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to individual CPT treatment. The public policy implications of the results of this trial are significant. If both treatment formats are equivalent or if group treatment is better, then group treatment would be a more efficient and cost-effective therapy modality in most cases. On the other hand, if individual therapy is found to be superior, the investment of greater resources into individual therapy will be justified in order to provide the most effective treatment for PTSD to military personnel. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Three hundred (300) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized between group and individual CPT-C."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD\n* Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)\n* Person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.\n* Be over the age of 18\n* Speak and read English\n* Be stable on any psychotropic medications they may be taking.\n\nExclusion Criteria:\n\n* Current suicide or homicide risk meriting crisis intervention\n* Active psychosis\n* Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)'}, 'identificationModule': {'nctId': 'NCT02173561', 'briefTitle': 'Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Boston Healthcare System'}, 'officialTitle': 'Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD', 'orgStudyIdInfo': {'id': 'W81XWH-08-2-0116-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Cognitive Processing Therapy-Cognitive Only', 'interventionNames': ['Behavioral: Group Cognitive Processing Therapy-Cognitive Only']}, {'type': 'EXPERIMENTAL', 'label': 'Individual Cognitive Processing Therapy-Cognitive Only', 'interventionNames': ['Behavioral: Individual Cognitive Processing Therapy-Cognitive Only']}], 'interventions': [{'name': 'Group Cognitive Processing Therapy-Cognitive Only', 'type': 'BEHAVIORAL', 'otherNames': ['Group CPT-C'], 'description': 'Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.', 'armGroupLabels': ['Group Cognitive Processing Therapy-Cognitive Only']}, {'name': 'Individual Cognitive Processing Therapy-Cognitive Only', 'type': 'BEHAVIORAL', 'otherNames': ['Individual CPT-C'], 'description': 'Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for six weeks; each session is 60 minutes.', 'armGroupLabels': ['Individual Cognitive Processing Therapy-Cognitive Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'country': 'United States', 'facility': 'Fort Hood Army Base', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}], 'overallOfficials': [{'name': 'Patricia A Resick, PhD, ABPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'VA Boston Healthcare System', 'class': 'FED'}, {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'STRONG STAR Consortium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Patricia Resick', 'investigatorAffiliation': 'Duke University'}}}}