A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
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|ClinicalTrials.gov Identifier: NCT00553956|
Recruitment Status : Unknown
Verified November 2007 by University of Konstanz.
Recruitment status was: Recruiting
First Posted : November 6, 2007
Last Update Posted : November 6, 2007
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|
|Posttraumatic Stress Disorder Depression Prolonged Grief Disorder||Behavioral: Narrative Exposure Therapy/Interpersonal Psychotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||August 2007|
|Estimated Study Completion Date :||February 2009|
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
- Symptoms of PTSD, depression, prolonged grief disorder [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553956
|Contact: Susanne Schaal, Dr.||0049-(0)7531-880||Susanne.Schaal@gmx.de|
|Butare, Province de Butare, Rwanda, 57645|
|Contact: Jean-Pierre Dusingizemungu, Prof. firstname.lastname@example.org|
|Principal Investigator:||Susanne Schaal||University of Konstanz|