Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02313818
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variable-length 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Variable length Cognitive Processing Therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)', 'timeFrame': 'Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment', 'description': 'PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.'}, {'measure': 'Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)', 'timeFrame': 'Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment', 'description': 'is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9', 'timeFrame': 'Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment', 'description': 'The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms (Kroenke, Spitzer, \\& Williams, 2001). It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for DSM MDD. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Posttraumatic Stress Disorder', 'Cognitive Processing Therapy', 'Active Duty Military'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '40045687', 'type': 'DERIVED', 'citation': 'Hass NC, Wachen JS, Straud CL, Checko E, McGeary DD, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. Changes in pain and related health outcomes after cognitive processing therapy in an active duty military sample. J Trauma Stress. 2025 Jun;38(3):447-457. doi: 10.1002/jts.23143. Epub 2025 Mar 5.'}, {'pmid': '29431455', 'type': 'DERIVED', 'citation': 'Foa EB, Zandberg LJ, McLean CP, Rosenfield D, Fitzgerald H, Tuerk PW, Wangelin BC, Young-McCaughan S, Peterson AL. The efficacy of 90-minute versus 60-minute sessions of prolonged exposure for posttraumatic stress disorder: Design of a randomized controlled trial in active duty military personnel. Psychol Trauma. 2019 Mar;11(3):307-313. doi: 10.1037/tra0000351. Epub 2018 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.', 'detailedDescription': 'The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female combat veterans who deployed in support of combat operations following 9/11\n* Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)\n* Speak and read English\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).\n* Local availability of fewer than 5 months\n* Late-phase Med Board status, awaiting percentages\n* Undergoing a chapter'}, 'identificationModule': {'nctId': 'NCT02313818', 'briefTitle': 'Variable-length Cognitive Processing Therapy for Combat-Related PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Variable-length Cognitive Processing Therapy for Combat-Related PTSD', 'orgStudyIdInfo': {'id': 'Pro00062853'}, 'secondaryIdInfos': [{'id': 'W81XWH-13-2-0012', 'type': 'OTHER', 'domain': 'VA Boston Healthcare System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPT-C', 'description': 'Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.', 'interventionNames': ['Behavioral: Cognitive Processing Therapy-Cognitive Only']}], 'interventions': [{'name': 'Cognitive Processing Therapy-Cognitive Only', 'type': 'BEHAVIORAL', '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 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 4-24 sessions; each session is 60 minutes.', 'armGroupLabels': ['CPT-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'country': 'United States', 'facility': 'Carl R Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}], 'overallOfficials': [{'name': 'Patricia A Resick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston VA Research Institute, Inc.', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'STRONG STAR Consortium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}