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

Posttraumatic Stress Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242136
• Other study ID #: UKULBU2014
• Status: Completed
• Phase: N/A
• First received: September 14, 2014
• Last updated: November 27, 2017
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2017
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Behavior
• Appetitive Aggression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• FORNET

Locations

Country	Name	City	State
Burundi	Burundian Army (FDN)	Bujumbura

Sponsors (3)

Lead Sponsor	Collaborator
University of Konstanz	The Volkswagen Foundation, Université Lumière de Bujumbura

Country where clinical trial is conducted

Burundi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)		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.
Primary	Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)		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.
Primary	Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)		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	Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)		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	Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)		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	Change in physical health complains		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.