Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 3:42 AM
Study NCT ID:
NCT00481000
Status:
UNKNOWN
Last Update Posted:
2010-04-21
First Post:
2007-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-20', 'studyFirstSubmitDate': '2007-05-31', 'studyFirstSubmitQcDate': '2007-05-31', 'lastUpdatePostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Symptoms (CAPS, SCID, PDS, IESR)', 'timeFrame': '1.5 years'}], 'secondaryOutcomes': [{'measure': 'general psychopathology', 'timeFrame': '1.5 years'}, {'measure': 'change of pain threshold', 'timeFrame': '1.5 years'}, {'measure': 'fMRI: activity of the amygdala', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dialectical Cognitive Therapy', 'Clinical Psychology'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '32368793', 'type': 'DERIVED', 'citation': 'Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.'}, {'pmid': '28717512', 'type': 'DERIVED', 'citation': 'Gorg N, Priebe K, Bohnke JR, Steil R, Dyer AS, Kleindienst N. Trauma-related emotions and radical acceptance in dialectical behavior therapy for posttraumatic stress disorder after childhood sexual abuse. Borderline Personal Disord Emot Dysregul. 2017 Jul 13;4:15. doi: 10.1186/s40479-017-0065-5. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD) following childhood sexual abuse.', 'detailedDescription': 'Most studies on psychological treatments for PTSD exclude patients with severe, co-occurring psychopathology. We designed a new treatment (Dialectical Cognitive Trauma Therapy, or DCT) specifically to treat these patients. DCT includes elements of emotion regulation, mindfulness exercises, cognitive and exposure treatment, as well as new elements. This randomized controlled study evaluates the effect of inpatient DCT on these patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Minimum age of 17\n* Childhood sexual abuse\n* Posttraumatic Stress Disorder (criteria of SCID)\n* At least one of the following diagnoses: Anorexia Nervosa, or Bulimia Nervosa, or substance abuse, or substance dependence, or major depression or at least 4 out of 9 criteria for Borderline Personality Disorder\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia\n* Mental retardation\n* Body Mass Index lower than 16.5\n* Acute delirium\n* Perilous selfharming behaviour during the last 4 month\n* Suicide attempt with the distinct intention to die during the last 4 month\n* Unstability (e.g. homelessness, acute victimisation by offender)\n* Pretreatment by DCT'}, 'identificationModule': {'nctId': 'NCT00481000', 'acronym': 'PASA', 'briefTitle': 'Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe Posttraumatic Stress Disorder Following Sexual Abuse - A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'PASA-0230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Waitlist; Treatment as usual', 'interventionNames': ['Behavioral: Dialectical Cognitive Therapy']}], 'interventions': [{'name': 'Dialectical Cognitive Therapy', 'type': 'BEHAVIORAL', 'description': 'Dialectical Behavior Therapy in Combination with Traumafocused CBT', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68159', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Central Institute of Mental Health', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Regina Steil, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Institute of Mental Health'}, {'name': 'Martin Bohus, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Central Institute of Mental Health'}, {'name': 'Anne S Dyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Institute of Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Martin Bohus', 'oldOrganization': 'Central Institute of Mental Health, Psychosomatic Clinic'}}}}