- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729325
Prevention of Post-Traumatic Stress Disorder in Soldiers
June 2, 2015 updated by: Anselm Crombach, University of Konstanz
Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bujumbura, Burundi
- Burundian Army (FDN)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No treatment control
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EXPERIMENTAL: Preventive Narrative Exposure Therapy
Treatment with Pre-NET before deployment in peace-keeping mission
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
Time Frame: 15 months
|
15 months
|
Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
Time Frame: 15 months
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 15 months
|
15 months
|
Strength of suicidal ideation measured via the MINI
Time Frame: 15 months
|
15 months
|
Physical health complains
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
November 13, 2012
First Submitted That Met QC Criteria
November 13, 2012
First Posted (ESTIMATE)
November 20, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 4, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKULBUSO2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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