- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625117
Mental Health and Aggression in Congolese Ex-combatants
June 25, 2013 updated by: Susanne Schaal, University of Konstanz
The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries.
Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression.
The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Goma, Congo
- Reintegration camp for ex-combatants
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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
16 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Ex-combatants in Congo who live in a re-integration camp
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
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Experimental: A variant of Narrative exposure therapy
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During the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts.
All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the therapist and the client try to go through all important traumatic experiences and perpetrated violent acts.
The sixth session is a group session with four to five clients.
The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Appetitive aggression (Appetitive Aggression Scale)
Time Frame: 6 months
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6 months
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Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS)
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Symptoms of depression (Mini-International Neuropsychiatric Interview)
Time Frame: 6 months
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6 months
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Functionality (Work and Social Adjustment Scale)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Thomas Elbert, Prof. Dr., University of Konstanz
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
May 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
June 20, 2012
First Posted (Estimate)
June 21, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFG_2011
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.