A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide

Phase 1

• Conditions: Posttraumatic Stress Disorder; Depression; Prolonged Grief Disorder
• Interventions: Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy

• Registration Number: NCT00553956
• Lead Sponsor: University of Konstanz

Brief Summary

In the framework of the epidemiological study, local psychologists are trained in Butare in carrying out diagnostic interviews with orphans and widows who experienced the Rwandan genocide. With the aid of standardized questionnaires they will assess trauma related symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from the University of Konstanz the local psychologists will carry out a randomized house to house survey (Phase 1).

As a second step, a controlled randomized clinical trial will be carried out. Local psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly be assigned to either the treatment condition or a waiting list. The treatment group will receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent 3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a significant symptom reduction in the experimental group and no significant symptom reduction in the waiting list. After the 6-months post-test, the trained psychologists will train other psychologists in applying this treatment module under the supervision of clinical experts from the University of Konstanz. Afterwards, they will apply therapy to the victims from the waiting list.

A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Status Verified: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Last Update Submitted: 2007-11-05
• Study First Posted: 2007-11-06
• Last Update Posted: 2007-11-06
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• widows and orphans
• confrontation of the Rwandan genocide
• clinical diagnosis of PTSD

Exclusion Criteria

• mental retardation
• psychotic symptoms
• current drug or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Narrative Exposure Therapy/Interpersonal Psychotherapy	Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT)

Primary Outcome Measures

Name	Time	Method
Symptoms of PTSD, depression, prolonged grief disorder	12 months

Trial Locations

Locations (1)

Victims Voice; 🇷🇼 Butare, Province de Butare, Rwanda