Prevention of Post-Traumatic Stress Disorder in Soldiers
Primary Purpose
Post-traumatic Stress Disorder (PTSD), Aggressive Behavior
Status
Completed
Phase
Phase 2
Locations
Burundi
Study Type
Interventional
Intervention
Preventive Narrative Exposure Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Post-traumatic Stress Disorder (PTSD) focused on measuring Post-traumatic Stress disorder (PTSD), Aggressive Behavior, Appetitive Aggression, Resilience, Preventive Narrative Exposure Therapy
Eligibility Criteria
Inclusion Criteria:
- Exposure to traumatic experiences derived from expert interviews with scores of the Traumatic Life Event List for War and Torture
- Soldiers are part of the Burundian army and of the joint African Union and United Nations peacekeeping mission in Somalia (AMISOM)
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
Preventive Narrative Exposure Therapy
No treatment control
Arm Description
Treatment with Pre-NET before deployment in peace-keeping mission
Outcomes
Primary Outcome Measures
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
Secondary Outcome Measures
Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
Strength of suicidal ideation measured via the MINI
Physical health complains
Full Information
NCT ID
NCT01729325
First Posted
November 13, 2012
Last Updated
June 2, 2015
Sponsor
University of Konstanz
Collaborators
The Volkswagen Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01729325
Brief Title
Prevention of Post-Traumatic Stress Disorder in Soldiers
Official Title
Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
The Volkswagen Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other mental disorders as a result of traumatic experiences. The effective prevention of mental disorders as a result of war deployment is expected to facilitate reintegration in civil life after deployment and reduce uncontrolled violence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD), Aggressive Behavior
Keywords
Post-traumatic Stress disorder (PTSD), Aggressive Behavior, Appetitive Aggression, Resilience, Preventive Narrative Exposure Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preventive Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
Treatment with Pre-NET before deployment in peace-keeping mission
Arm Title
No treatment control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Preventive Narrative Exposure Therapy
Intervention Description
During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.
Primary Outcome Measure Information:
Title
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
Time Frame
15 months
Title
Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
15 months
Title
Strength of suicidal ideation measured via the MINI
Time Frame
15 months
Title
Physical health complains
Time Frame
15 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Exposure to traumatic experiences derived from expert interviews with scores of the Traumatic Life Event List for War and Torture
Soldiers are part of the Burundian army and of the joint African Union and United Nations peacekeeping mission in Somalia (AMISOM)
Exclusion Criteria:
Current use of mind altering drugs
Psychotic symptoms
Facility Information:
Facility Name
Burundian Army (FDN)
City
Bujumbura
Country
Burundi
12. IPD Sharing Statement
Learn more about this trial
Prevention of Post-Traumatic Stress Disorder in Soldiers
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