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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by University of Konstanz.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553956
First Posted: November 6, 2007
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by:
University of Konstanz
November 5, 2007
November 6, 2007
November 6, 2007
August 2007
Not Provided
Symptoms of PTSD, depression, prolonged grief disorder [ Time Frame: 12 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
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-

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Depression
  • Prolonged Grief Disorder
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.
  • 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)
    Intervention: Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy
  • No Intervention: 2
    Waiting list control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
February 2009
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • mental retardation
  • psychotic symptoms
  • current drug or alcohol
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Rwanda
 
 
NCT00553956
NET_IPT
Not Provided
Not Provided
Not Provided
Not Provided
University of Konstanz
German Research Foundation
Principal Investigator: Susanne Schaal University of Konstanz
University of Konstanz
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP