Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-06 @ 8:44 PM
Study NCT ID:
NCT00550056
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2007-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement
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': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-25', 'studyFirstSubmitDate': '2007-10-25', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Expert diagnosis of PTSD established with CIDI interview', 'timeFrame': '9 months'}, {'measure': 'Physical health symptoms assessed with a checklist', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD, Posttraumatic Stress Disorder, refugees, war'], 'conditions': ['Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.', 'detailedDescription': 'Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.\n\nTe purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of posttraumatic stress disorder\n\nExclusion Criteria:\n\n* Drug abuse\n* Psychosis\n* Mental retardation'}, 'identificationModule': {'nctId': 'NCT00550056', 'briefTitle': 'Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement', 'orgStudyIdInfo': {'id': 'NeEl-Ug-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'NET', 'interventionNames': ['Behavioral: Narrative Exposure Therapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'TC', 'interventionNames': ['Behavioral: Trauma Counselling']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Monitoring Group'}], 'interventions': [{'name': 'Narrative Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'Six session of Narrative Exposure Therapy', 'armGroupLabels': ['1']}, {'name': 'Trauma Counselling', 'type': 'BEHAVIORAL', 'description': 'Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'state': 'Mbarara', 'country': 'Uganda', 'facility': 'Nakivale Refugee Camp', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Thomas Elbert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Konstanz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}]}}}