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Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Phase 3

Locations

Uganda

Study Type

Interventional

Intervention

Narrative Exposure Therapy

Trauma Counselling

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Posttraumatic Stress Disorder, refugees, war

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of posttraumatic stress disorder

Exclusion Criteria:

Drug abuse
Psychosis
Mental retardation

Sites / Locations

Nakivale Refugee Camp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

NET

Monitoring Group

Outcomes

Primary Outcome Measures

Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale

Secondary Outcome Measures

Expert diagnosis of PTSD established with CIDI interview

Physical health symptoms assessed with a checklist

Full Information

NCT ID

NCT00550056

First Posted

October 25, 2007

Last Updated

October 25, 2007

Sponsor

University of Konstanz

Collaborators

German Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00550056

Brief Title

Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

Official Title

Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Konstanz

Collaborators

German Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

PTSD, Posttraumatic Stress Disorder, refugees, war

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

NET

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

No Intervention

Arm Description

Monitoring Group

Intervention Type

Behavioral

Intervention Name(s)

Narrative Exposure Therapy

Intervention Description

Six session of Narrative Exposure Therapy

Intervention Type

Behavioral

Intervention Name(s)

Trauma Counselling

Intervention Description

Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist

Primary Outcome Measure Information:

Title

Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Expert diagnosis of PTSD established with CIDI interview

Time Frame

9 months

Title

Physical health symptoms assessed with a checklist

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of posttraumatic stress disorder Exclusion Criteria: Drug abuse Psychosis Mental retardation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Elbert, PhD

Organizational Affiliation

University of Konstanz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nakivale Refugee Camp

City

Mbarara

Country

Uganda

12. IPD Sharing Statement

Learn more about this trial

Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

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