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

NCT02242136 | Completed DMC

• 1 other identifier: UKULBU2014
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Aggressive Behavior; Appetitive Aggression

Keywords

Posttraumatic Stress Disorder; Aggressive Behavior; Appetitive Aggression; Treatment; FORNET

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

FORNET

EXPERIMENTAL

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

Waiting list

NO INTERVENTION

Interventions

FORNET BEHAVIORAL

FORNET

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current use of mind altering drugs,
• Psychotic symptoms

Sponsors & Collaborators

• University of Konstanz: lead
• Université Lumière de Bujumbura: collaborator
• The Volkswagen Foundation: collaborator

Study Sites (1)

Burundian Army (FDN)

Bujumbura, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Aggression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Anselm Crombach, Dr.

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

BU (1)