NCT01624987

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

June 19, 2012

Last Update Submit

July 29, 2013

Conditions

Keywords

Treatment of ex-combatantsFORNET for ex-combatantsAppetitive AggressionPost-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Appetitive Aggression (Appetitive Aggression Scale)

    6 months

  • Symptoms of post-traumatic stress disorder (Post-traumatic Diagnostic Scale, PDS)

    6 months

Secondary Outcomes (4)

  • Symptoms of depression (Patient Health Questionnaire (PHQ-9)

    6 months

  • Functionality (Work and Social Adjustment Scale)

    6 months

  • Substance abuse

    6 months

  • Re-integration questionnaire

    6 months

Study Arms (1)

NET for Forensic Offender Rehabilitation

EXPERIMENTAL

Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)

Behavioral: NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure TherapyOther: Control group

Interventions

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.

NET for Forensic Offender Rehabilitation

The control group receives no intervention.

NET for Forensic Offender Rehabilitation

Eligibility Criteria

Age16 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transit Camp for ex-combatants/Reintegration camp for ex-combatants (ETN)

Goma, Republic of the Congo

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Thomas Elbert, Prof. Dr.

    University of Konstanz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susanne Schaal

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations