- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00623298
Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy
February 25, 2008 updated by: University of Konstanz
Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy -A Controlled Clinical Trial With Orphaned Survivors of the Rwandan Genocide
The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT).
We used a half year baseline to measure the treatment-induced changes.
We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The 1994 genocide of Rwanda has left countless children orphaned.
26 Rwandan orphans who fulfilled DSM-IV diagnosis of PTSD were offered participation in a controlled treatment trial.
A group adaptation of Interpersonal Psychotherapy (IPT, n = 14) was compared to Narrative Exposure Therapy (NET, n = 12).
Main outcome measures were symptoms of PTSD and depression assessed pre-treatment, 3 months after therapy (post-test) and 6 months after therapy (follow-up) using the CAPS, MINI and Hamilton Rating Scale.
At post-test, participants in both treatment conditions showed reductions in posttraumatic stress symptoms and depression symptoms.
At 6-month follow-up, NET proved to be more effective in the treatment of PTSD.
Only 25% (n = 3) of NET-participants but 71% (n = 10) of the IPT-participants still fulfilled PTSD criteria at follow-up.
Although there was a significant reduction in depression symptoms in both treatment groups from pre-test to follow-up, NET again proved to be more effective.
This treatment-trial demonstrates that NET and group-IPT are suitable treatment modules even when most severe traumatic stress and difficult living conditions have led to chronic mental suffering.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 29 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide
Exclusion Criteria:
- Mental retardation
- Psychotic symptoms or current drug or alcohol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
NET
|
|
|
No Intervention: 3
6-months baseline
|
|
|
Experimental: 2
group IPT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Symptoms of posttraumatic stress disorder, symptoms of depression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
February 14, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
February 26, 2008
Study Record Updates
Last Update Posted (Estimate)
February 26, 2008
Last Update Submitted That Met QC Criteria
February 25, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fogr SOSS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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