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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Konstanz.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
University of Konstanz
ClinicalTrials.gov Identifier:
NCT00553956
First received: November 5, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorder
Depression
Prolonged Grief Disorder
Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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-

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • Symptoms of PTSD, depression, prolonged grief disorder [ Time Frame: 12 months ]

Estimated Enrollment: 150
Study Start Date: August 2007
Estimated Study Completion Date: February 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553956

Contacts
Contact: Susanne Schaal, Dr. 0049-(0)7531-880 Susanne.Schaal@gmx.de

Locations
Rwanda
Victims Voice Recruiting
Butare, Province de Butare, Rwanda, 57645
Contact: Jean-Pierre Dusingizemungu, Prof.       dusingize@yahoo.fr   
Sponsors and Collaborators
University of Konstanz
German Research Foundation
Investigators
Principal Investigator: Susanne Schaal University of Konstanz
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00553956     History of Changes
Other Study ID Numbers: NET_IPT
Study First Received: November 5, 2007
Last Updated: November 5, 2007
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on July 31, 2014