- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00550056
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement
October 25, 2007 updated by: University of Konstanz
Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.
Study Type
Interventional
Enrollment (Actual)
277
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mbarara, Uganda
- Nakivale Refugee Camp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of posttraumatic stress disorder
Exclusion Criteria:
- Drug abuse
- Psychosis
- Mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
NET
|
Six session of Narrative Exposure Therapy
|
|
Experimental: 2
TC
|
Six sessions of Trauma Counselling, using a variety of skills incl.
exposure methods following the skills of the therapist
|
|
No Intervention: 3
Monitoring Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Expert diagnosis of PTSD established with CIDI interview
Time Frame: 9 months
|
9 months
|
|
Physical health symptoms assessed with a checklist
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Elbert, PhD, University of Konstanz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
October 25, 2007
First Submitted That Met QC Criteria
October 25, 2007
First Posted (Estimate)
October 26, 2007
Study Record Updates
Last Update Posted (Estimate)
October 26, 2007
Last Update Submitted That Met QC Criteria
October 25, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeEl-Ug-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.