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Completed

NCT Number: NCT02242136

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Aberrant Motor Behavior in Dementia Aggression Aggressive Behavior Appetitive Aggression Behavior Behavioral Symptoms Mental Disorders Social Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burundian Army (FDN)

Bujumbura, Burundi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FORNET

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Collaborators

  • The Volkswagen Foundation
  • Université Lumière de Bujumbura

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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