- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624987
Intervention to Support the Reintegration of Former Combatants and Soldiers
Study Overview
Status
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.
The project consists of four steps:
- Training of selected DDRRR personnel(first generation)in FORNET (a variant of Narrative Exposure Therapy to treat trauma-related disorders and to reduce appetitive aggression)by experts from the University of Konstanz.
- Treatment phase 1: Intervention will be carried out by therapists of the first generation. The trained therapists of the first generation will be supervised from the experts of the University of Konstanz.
- Training of a second generation of DDRRR personnel in FORNET by the therapists of the first generation.
- Treatment phase 2: Intervention will be carried out by therapists of the second generation. The trained therapists of the second generation will be supervised from the therapists of the first generation.
The study is conceived as a randomized controlled study. In phase 1 and in phase 2, study participants will be randomized allocated to the intervention group (FORNET) and the control group (no intervention). The treatment effect will be measured by pre-post and 6-months follow-up evaluations.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
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Goma, Congo
- Transit Camp for ex-combatants/Reintegration camp for ex-combatants (ETN)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ex-combatants who live in a transit camp in Goma, Congo.
Exclusion Criteria:
Study Plan
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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Experimental: NET for Forensic Offender Rehabilitation
Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)
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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 trained 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.
The control group receives no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Appetitive Aggression (Appetitive Aggression Scale)
Time Frame: 6 months
|
6 months
|
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Symptoms of post-traumatic stress disorder (Post-traumatic Diagnostic Scale, PDS)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functionality (Work and Social Adjustment Scale)
Time Frame: 6 months
|
6 months
|
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Symptoms of depression (Patient Health Questionnaire (PHQ-9)
Time Frame: 6 months
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6 months
|
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Substance abuse
Time Frame: 6 months
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6 months
|
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Re-integration questionnaire
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Thomas Elbert, Prof. Dr., University of Konstanz
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WB_2012
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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