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

Primary Purpose

Posttraumatic Stress Disorder, Aggressive Behavior, Appetitive Aggression

Status
Completed
Phase
Not Applicable
Locations
Burundi
Study Type
Interventional
Intervention
FORNET
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Aggressive Behavior, Appetitive Aggression, Treatment, FORNET

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burundian Army (FDN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FORNET

Waiting list

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I)
Change from baseline in the extend of appetitive aggression assessed via the Appetitive Aggression Scale (AAS)
Change in number of committed violent acts during the past three months assessed via the Domestic and Community Violence Checklist (DCVC)

Secondary Outcome Measures

Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9)
Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.)
Change in physical health complains

Full Information

First Posted
September 14, 2014
Last Updated
November 27, 2017
Sponsor
University of Konstanz
Collaborators
Université Lumière de Bujumbura, The Volkswagen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02242136
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Université Lumière de Bujumbura, The Volkswagen Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Aggressive Behavior, Appetitive Aggression
Keywords
Posttraumatic Stress Disorder, Aggressive Behavior, Appetitive Aggression, Treatment, FORNET

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FORNET
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
FORNET
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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 Outcome Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anselm Crombach, Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burundian Army (FDN)
City
Bujumbura
Country
Burundi

12. IPD Sharing Statement

Learn more about this trial

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

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