Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants

November 27, 2017 updated by: Anselm Crombach, University of Konstanz

Formation, Orientation and Rehabilitation by Means of Narrative Exposure Therapy (FORNET) for Returning Soldiers of the African Union Mission to Somalia, Male and Female Ex-combatants in Burundi

Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former conflict regions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The treatment program Formation, Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior. Addressing trauma-related mental disorders as well as emotions related to aggression by means of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled violence.

The investigators want to provide evidence, that FORNET is an effective and efficient module to assist soldiers after deployment in Somalia and/or male and female ex-combatants who fought in the civil war in Burundi. In addition the investigators aim to explore how traumatic incidences and maltreatment during childhood may influence treatment outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burundi
      • Bujumbura, Burundi
        • Burundian Army (FDN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale,
  • High degree of appetitive aggression,
  • Violent behavior during the past three months

Exclusion Criteria:

  • Current use of mind altering drugs,
  • Psychotic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting list
Experimental: FORNET
During FORNET, the client, with the assistance of the therapist, constructs a chronological narrative of his or her entire life with a focus on exposure to traumatic stress and committed violence. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior. The therapist asks in detail for the client's emotions, cognitions, physiological reactions, and sensory informations during traumatic and aggressive events to link them to an autobiographical context, namely time and place. In total the individuals receive 8 sessions of FORNET, every session lasting between 1,5 and 2 hrs depending on the needs of the participant.
Behavioral: FORNET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
Change in physical health complains
Time Frame: baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.
baseline, two follow-up assessments are planned within the period of 3 to 12 months post-treatment. Exact time of follow-up will be varied systematically within this period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Konstanz

Collaborators

The Volkswagen Foundation
Université Lumière de Bujumbura

Investigators

  • Principal Investigator: Anselm Crombach, Dr., University of Konstanz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 14, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKULBU2014

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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