A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
Primary Purpose
Posttraumatic Stress Disorder, Depression, Prolonged Grief Disorder
Status
Unknown status
Phase
Phase 1
Locations
Rwanda
Study Type
Interventional
Intervention
Narrative Exposure Therapy/Interpersonal Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility 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
Sites / Locations
- Victims VoiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT)
Waiting list control
Outcomes
Primary Outcome Measures
Symptoms of PTSD, depression, prolonged grief disorder
Secondary Outcome Measures
Full Information
NCT ID
NCT00553956
First Posted
November 5, 2007
Last Updated
November 5, 2007
Sponsor
University of Konstanz
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00553956
Brief Title
A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Konstanz
Collaborators
German Research Foundation
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression, Prolonged Grief Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intervention group A treatment combination of Narrative Exposure Therapy and Interpersonal Psychotherapy (5 individual sessions NET in addition to 3 individual sessions IPT)
Arm Title
2
Arm Type
No Intervention
Arm Description
Waiting list control
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy/Interpersonal Psychotherapy
Intervention Description
The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.
Primary Outcome Measure Information:
Title
Symptoms of PTSD, depression, prolonged grief disorder
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Schaal, Dr.
Phone
0049-(0)7531-880
Email
Susanne.Schaal@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Schaal
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victims Voice
City
Butare
State/Province
Province de Butare
ZIP/Postal Code
57645
Country
Rwanda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Dusingizemungu, Prof.
Email
dusingize@yahoo.fr
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
We'll reach out to this number within 24 hrs