Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT00383006
Status:
WITHDRAWN
Last Update Posted:
2009-06-03
First Post:
2006-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Affect Management Group for Adult Survivors of Childhood Trauma
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'whyStopped': 'Difficulties in finding enough study participants.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2006-09-29', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)', 'timeFrame': '2008'}], 'secondaryOutcomes': [{'measure': 'Score on depression at week 14 (post-interventional) and month 3 (follow-up)', 'timeFrame': '2008'}, {'measure': 'Score on life quality at week 14 (post-interventional) and month 3 (follow-up)', 'timeFrame': '2008'}, {'measure': 'Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)', 'timeFrame': '2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychotherapy, Group', 'Stress Disorders, Post-Traumatic', 'Ambulatory Care'], 'conditions': ['Stress Disorders, Post-Traumatic']}, 'descriptionModule': {'briefSummary': "Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. The hypothesis is that the group therapy significantly improves the participant's capacity in emotion management and self-soothing.", 'detailedDescription': 'Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. Since sufficient capacity for self soothing and emotional regulation are essential for trauma exposure, modern trauma therapy concepts are phase-oriented, beginning with working on "stabilization". The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. Inclusion criteria are clinical significant problems with self-regulation and the presence of childhood trauma. Outcome measures are based on self-rating questionnaires, clinical interviews and an experimental computer-task at timepoint pre-, post- and 3-month-follow-up. There is no control condition in the pilot-study phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with moderate to severe relational trauma in childhood (emotional, sexual or physical abuse, emotional or physical neglect)\n* DSM-IV diagnosis of posttraumatic stress disorder\n\nExclusion Criteria:\n\n* Severe dissociation\n* Environmental safety problems\n* Ongoing enmeshment with perpetrators\n* Psychotic disorders\n* Severe depression\n* Acute suicidality\n* Substance abuse\n* Severe cognitive decline'}, 'identificationModule': {'nctId': 'NCT00383006', 'briefTitle': 'Affect Management Group for Adult Survivors of Childhood Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'orgStudyIdInfo': {'id': 'PSYUNIZH26092006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Skills for affect regulation (behavior)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Psychiatry, University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Christoph Mueller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland'}, {'name': 'Michael Rufer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}}}}