NCT01625117

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

January 16, 2012

Last Update Submit

June 25, 2013

Conditions

Appetitive AggressionPosttraumatic Stress Disorder

Keywords

Treatment of ex-combatantsNarrative Exposure Therapy for ex-combatantsAppetitive AggressionPosttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Appetitive aggression (Appetitive Aggression Scale)

    6 months

  • Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS)

    6 months

Secondary Outcomes (2)

  • Symptoms of depression (Mini-International Neuropsychiatric Interview)

    6 months

  • Functionality (Work and Social Adjustment Scale)

    6 months

Study Arms (2)

Control Group

NO INTERVENTION

A variant of Narrative exposure therapy

EXPERIMENTAL
Behavioral: A variant of Narrative Exposure Therapy

Interventions

A variant of Narrative Exposure TherapyBEHAVIORAL

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.

A variant of Narrative exposure therapy

Eligibility Criteria

Age16 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reintegration camp for ex-combatants

Goma, Republic of the Congo

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

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

January 16, 2012

First Posted

June 21, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

RE(1)