Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT00245232
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2005-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptoms; measured immediately post-treatment and 6 months post-treatment'}, {'measure': 'Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment'}]}, 'conditionsModule': {'keywords': ['PTSD', 'Cognitive therapy', 'Rape'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '12182270', 'type': 'RESULT', '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': '37795783', 'type': 'DERIVED', 'citation': "O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2."}, {'pmid': '36848714', 'type': 'DERIVED', 'citation': 'Fitzpatrick SS, Liebman RE, Monson CM, Resick PA. Latent emotion profiles of PTSD and specific emotions predicting differential therapy outcomes in a dismantling study of cognitive processing therapy. J Anxiety Disord. 2023 Apr;95:102681. doi: 10.1016/j.janxdis.2023.102681. Epub 2023 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.', 'detailedDescription': 'PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.\n\nParticipants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of a discrete episode of assault in childhood or adulthood\n* Meets criteria for post-traumatic stress disorder\n\nExclusion Criteria:\n\n* Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence\n* Psychosis\n* Mental retardation\n* Suicidal or parasuicidal\n* Currently addicted to drugs\n* Illiterate\n* Currently in an abusive relationship\n* Currently being stalked'}, 'identificationModule': {'nctId': 'NCT00245232', 'briefTitle': 'Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, St. Louis'}, 'officialTitle': 'Cognitive Processes in PTSD: Treatment', 'orgStudyIdInfo': {'id': 'R01MH051509-06', 'link': 'https://reporter.nih.gov/quickSearch/R01MH051509-06', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH051509-06', 'link': 'https://reporter.nih.gov/quickSearch/R01MH051509-06', 'type': 'NIH'}, {'id': 'DSIR AT-AS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive Therapy', 'type': 'BEHAVIORAL'}, {'name': 'Cognitive Processing Therapy', 'type': 'BEHAVIORAL'}, {'name': 'Written Exposure', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63121-4499', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Center for Trauma and Recovery, University of Missouri - St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Patricia A. Resick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "National Center for PTSD, Women's Health Sciences Division"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, St. Louis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}]}}}