Prevention of Post-Traumatic Stress Disorder in Soldiers

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729325
• Other study ID #: UKULBUSO2012
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2012
• Last updated: June 2, 2015
• Start date: November 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aggression
• Aggressive Behavior
• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Preventive Narrative Exposure Therapy
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.

Locations

Country	Name	City	State
Burundi	Burundian Army (FDN)	Bujumbura

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	The Volkswagen Foundation

Country where clinical trial is conducted

Burundi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)		15 months	No
Primary	Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)		15 months	No
Secondary	Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)		15 months	No
Secondary	Strength of suicidal ideation measured via the MINI		15 months	No
Secondary	Physical health complains		15 months	No