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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1:Epidemiological Study of PTSD and Comorbid Disorders in Widows and Orphans Who Experienced the Rwandan Genocide Phase 2: A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Genocide Carried Out by Trained Local Psychologists -NET/IPT Versus Waiting List-

Conditions
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Posttraumatic Stress Disorder, Depression, Prolonged Grief Disorder

Intervention / Treatment
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* Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: widows and orphans confrontation of the Rwandan genocide clinical diagnosis of PTSD Exclusion Criteria: mental retardation psychotic symptoms current drug or alcohol

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT) | Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy<br>* The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.<br>|
| No Intervention: 2<br>Waiting list control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of PTSD, depression, prolonged grief disorder |  | 12 months |