Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-06 @ 7:32 PM
Study NCT ID:
NCT00329992
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2006-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2006-05-23', 'studyFirstSubmitQcDate': '2006-05-23', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores', 'timeFrame': 'Last month'}], 'secondaryOutcomes': [{'measure': 'Ability to work and use of health care facilities', 'timeFrame': 'Last months'}, {'measure': 'Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983)', 'timeFrame': 'Last month'}, {'measure': 'Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)', 'timeFrame': 'Last month'}, {'measure': 'Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)', 'timeFrame': 'Last month'}, {'measure': 'Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)', 'timeFrame': 'Since trauma'}, {'measure': 'EEG, event-related potentials: P300', 'timeFrame': 'At assessment'}, {'measure': 'Post-therapy / post-waitlist comparison, follow-up at 6month post therapy', 'timeFrame': 'Last month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '21527127', 'type': 'DERIVED', 'citation': 'Schnyder U, Muller J, Maercker A, Wittmann L. Brief eclectic psychotherapy for PTSD: a randomized controlled trial. J Clin Psychiatry. 2011 Apr;72(4):564-6. doi: 10.4088/JCP.10l06247blu. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a waiting time of four months. Participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al. (1999) Behavior Therapy 30: 597-605) for three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clear memory of an "index" traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (Montgomery and Bech 2000)\n* PTSD according to the DSM-IV, related to the index traumatic event, as measured with the CAPS: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50\n* Not receiving other psychotherapy for PTSD during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed\n* If on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial\n* Aged between 18 and 70 years\n* Sufficient proficiency in the German language to participate in BEP\n* Consent to be randomized into the trial\n\nExclusion Criteria:\n\n* Current psychotic, bipolar, substance-related, or severe personality disorder\n* Current severe depressive disorder\n* Severe cognitive impairment or a history of organic mental disorder\n* Evidence of PTSD or depression immediately prior to the index trauma\n* Ongoing threat of traumatic exposure\n* Prominent current suicidal or homicidal ideation\n* Asylum seeking status'}, 'identificationModule': {'nctId': 'NCT00329992', 'briefTitle': 'Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3200BO-102204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': '16 sessions Brief Eclectic Psychotherapy', 'interventionNames': ['Behavioral: Brief Eclectic Psychotherapy for PTSD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Minimal attention waitlist group', 'interventionNames': ['Behavioral: Brief Eclectic Psychotherapy for PTSD']}], 'interventions': [{'name': 'Brief Eclectic Psychotherapy for PTSD', 'type': 'BEHAVIORAL', 'otherNames': ['BEP'], 'description': '16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD', 'armGroupLabels': ['Control group', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Psychiatric Department, University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Ulrich Schnyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}, {'name': 'Lutz Wittmann, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}, {'name': 'Herrmann-Klaus-Stiftung, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Olga Mayenfisch Stiftung, Zurich, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Jubiläumsspende für die Universität Zürich, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Ulrich Schnyder, MD', 'oldOrganization': 'University Hospital Zurich, Switzerland'}}}}