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NCT01625117 Clinical Trial

Mental Health and Aggression in Congolese Ex-combatants

Posttraumatic Stress Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01625117
Other study ID # DFG_2011
Secondary ID
Status Completed
Phase Phase 2
First received January 16, 2012
Last updated June 25, 2013
Start date May 2011
Est. completion date September 2012

Study information
Verified date June 2013
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Male
Age group 16 Years to 35 Years
Eligibility Inclusion Criteria:

- Ex-combatants in Congo who live in a re-integration camp

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• A variant of Narrative Exposure Therapy
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.

Locations
Country Name City State
Congo Reintegration camp for ex-combatants Goma

Sponsors (2)
Lead Sponsor Collaborator
University of Konstanz German Research Foundation

Country where clinical trial is conducted

Congo, 

Outcome
Type Measure Description Time frame Safety issue
Primary Appetitive aggression (Appetitive Aggression Scale) 6 months No
Primary Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS) 6 months No
Secondary Symptoms of depression (Mini-International Neuropsychiatric Interview) 6 months No
Secondary Functionality (Work and Social Adjustment Scale) 6 months No
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