Intervention to Support the Reintegration of Former Combatants and Soldiers

Post-traumatic Stress Disorder Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01624987
• Other study ID #: WB_2012
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: June 19, 2012
• Last updated: July 29, 2013
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2013
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethic Commission
• Study type: Interventional

Clinical Trial Summary

The project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel (phase 1). In a second step, the project aims to investigates the treatment success if this specific therapy is carried out by local personnel who have been trained by other local personnel ("train the trainer", phase 2) under the supervision of experts of the University of Konstanz.

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:

1. 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.

2. 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.

3. Training of a second generation of DDRRR personnel in FORNET by the therapists of the first generation.

4. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• Ex-combatants who live in a transit camp in Goma, Congo.

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Aggression
• Appetitive Aggression
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• NET for Forensic Offender Rehabilitation (FORNET): 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 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.

Other:
• Control group
The control group receives no intervention.

Locations

Country	Name	City	State
Congo	Transit Camp for ex-combatants/Reintegration camp for ex-combatants (ETN)	Goma

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	World Bank

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 post-traumatic stress disorder (Post-traumatic Diagnostic Scale, PDS)		6 months	No
Secondary	Symptoms of depression (Patient Health Questionnaire (PHQ-9)		6 months	No
Secondary	Functionality (Work and Social Adjustment Scale)		6 months	No
Secondary	Substance abuse		6 months	No
Secondary	Re-integration questionnaire		6 months	No