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

Sponsor
University of Konstanz (Other)
Overall Status
Unknown status
CT.gov ID
NCT00553956
Collaborator
German Research Foundation (Other)
150
1
2
18.1
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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-
Study Start Date :
Aug 1, 2007
Anticipated Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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
The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.

No Intervention: 2

Waiting list control

Outcome Measures

Primary Outcome Measures

  1. Symptoms of PTSD, depression, prolonged grief disorder [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • widows and orphans

  • confrontation of the Rwandan genocide

  • clinical diagnosis of PTSD

Exclusion Criteria:
  • mental retardation

  • psychotic symptoms

  • current drug or alcohol

Contacts and Locations

Locations

Site City State Country Postal Code
1 Victims Voice Butare Province de Butare Rwanda 57645

Sponsors and Collaborators

  • University of Konstanz
  • German Research Foundation

Investigators

  • Principal Investigator: Susanne Schaal, University of Konstanz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00553956
Other Study ID Numbers:
  • NET_IPT
First Posted:
Nov 6, 2007
Last Update Posted:
Nov 6, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2007