Clinical trial NCT02242136: Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Aggressive Behavior
Appetitive Aggression
Keywords: Posttraumatic Stress Disorder
Aggressive Behavior
Appetitive Aggression
Treatment
FORNET
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Université Lumière de Bujumbura
name: The Volkswagen Foundation
First posted: 2014-09-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)
timeFrame: 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.
measure: Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)
timeFrame: 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.
measure: Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)
timeFrame: 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:
measure: Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 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.
measure: Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)
timeFrame: 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.
measure: Change in physical health complains
timeFrame: 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.
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: Burundian Army (FDN)
Study officials:
affiliation: University of Konstanz
name: Anselm Crombach, Dr.
role: PRINCIPAL_INVESTIGATOR
References: