NCT00550056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
Last Updated

October 26, 2007

Status Verified

October 1, 2007

First QC Date

October 25, 2007

Last Update Submit

October 25, 2007

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD, Posttraumatic Stress Disorder, refugees, war

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale

    9 months

Secondary Outcomes (2)

  • Expert diagnosis of PTSD established with CIDI interview

    9 months

  • Physical health symptoms assessed with a checklist

    9 months

Study Arms (3)

1

EXPERIMENTAL

NET

Behavioral: Narrative Exposure Therapy

2

EXPERIMENTAL

TC

Behavioral: Trauma Counselling

3

NO INTERVENTION

Monitoring Group

Interventions

Narrative Exposure TherapyBEHAVIORAL

Six session of Narrative Exposure Therapy

1
Trauma CounsellingBEHAVIORAL

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of posttraumatic stress disorder

You may not qualify if:

  • Drug abuse
  • Psychosis
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nakivale Refugee Camp

Mbarara, Mbarara, Uganda

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Thomas Elbert, PhD

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 26, 2007

Study Start

January 1, 2003

Study Completion

April 1, 2004

Last Updated

October 26, 2007

Record last verified: 2007-10

Locations

UG(1)