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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00550056
Other study ID # NeEl-Ug-01
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2007
Last updated October 25, 2007
Start date January 2003
Est. completion date April 2004

Study information

Verified date October 2007
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Uganda: Office of the Prime Minister
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 277
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of posttraumatic stress disorder

Exclusion Criteria:

- Drug abuse

- Psychosis

- Mental retardation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Narrative Exposure Therapy
Six session of Narrative Exposure Therapy
Trauma Counselling
Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist

Locations

Country Name City State
Uganda Nakivale Refugee Camp Mbarara

Sponsors (2)

Lead Sponsor Collaborator
University of Konstanz German Research Foundation

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale 9 months
Secondary Expert diagnosis of PTSD established with CIDI interview 9 months
Secondary Physical health symptoms assessed with a checklist 9 months
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