Prevention of Post-Traumatic Stress Disorder in Soldiers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Volkswagen Stiftung Germany
Information provided by (Responsible Party):
Anselm Crombach, University of Konstanz
ClinicalTrials.gov Identifier:
NCT01729325
First received: November 13, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Post-traumatic Stress Disorder (PTSD)
Aggressive Behavior
Behavioral: Preventive Narrative Exposure Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Strength of suicidal ideation measured via the MINI [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Physical health complains [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preventive Narrative Exposure Therapy
Treatment with Pre-NET before deployment in peace-keeping mission
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.
No Intervention: No treatment control

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729325

Locations
Burundi
Burundian Army (FDN)
Bujumbura, Burundi
Sponsors and Collaborators
University of Konstanz
Volkswagen Stiftung Germany
  More Information

No publications provided

Responsible Party: Anselm Crombach, Dipl.-Psych., University of Konstanz
ClinicalTrials.gov Identifier: NCT01729325     History of Changes
Other Study ID Numbers: UKULBUSO2012
Study First Received: November 13, 2012
Last Updated: June 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Konstanz:
Post-traumatic Stress disorder (PTSD)
Aggressive Behavior
Appetitive Aggression
Resilience
Preventive Narrative Exposure Therapy

Additional relevant MeSH terms:
Aggression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014