NCT01729325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

November 13, 2012

Last Update Submit

June 2, 2015

Conditions

Keywords

Post-traumatic Stress disorder (PTSD)Aggressive BehaviorAppetitive AggressionResiliencePreventive Narrative Exposure Therapy

Outcome Measures

Primary Outcomes (2)

  • Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)

    15 months

  • Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)

    15 months

Secondary Outcomes (3)

  • Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)

    15 months

  • Strength of suicidal ideation measured via the MINI

    15 months

  • Physical health complains

    15 months

Study Arms (2)

Preventive Narrative Exposure Therapy

EXPERIMENTAL

Treatment with Pre-NET before deployment in peace-keeping mission

Behavioral: Preventive Narrative Exposure Therapy

No treatment control

NO INTERVENTION

Interventions

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.

Preventive Narrative Exposure Therapy

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Current use of mind altering drugs
  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burundian Army (FDN)

Bujumbura, Bujumbura Mairie Province, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAggression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl.-Psych.

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

April 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations