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

Depression Clinical Trial

Official title:

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-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553956
• Other study ID #: NET_IPT
• Status: Recruiting
• Phase: Phase 1
• First received: November 5, 2007
• Last updated: November 5, 2007
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: November 2007
• Source: University of Konstanz
• Contact: Susanne Schaal, Dr.
• Phone: 0049-(0)7531-880
• Email: Susanne.Schaal[@]gmx.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Disease
• Posttraumatic Stress Disorder
• Prolonged Grief Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy/Interpersonal Psychotherapy
The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.

Locations

Country	Name	City	State
Rwanda	Victims Voice	Butare	Province de Butare

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	German Research Foundation

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of PTSD, depression, prolonged grief disorder		12 months