Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-29 @ 9:22 PM
Study NCT ID:
NCT00553956
Status:
UNKNOWN
Last Update Posted:
2007-11-06
First Post:
2007-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
Sponsor:
University of Konstanz
Organization:
Study Overview
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-
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: