Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Active ABMT8; Behavioral: Active ABMT4; Behavioral: Placebo

• Registration Number: NCT01723215
• Lead Sponsor: Tel Aviv University

Brief Summary

Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Study Start: 2012-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 862

Inclusion Criteria

• combat soldiers

Exclusion Criteria

• Fluent Hebrew

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Active ABMT8	Active ABMT8	Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
Active ABMT4	Active ABMT4	Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
Placebo	Placebo	Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns

Primary Outcome Measures

Name	Time	Method
Changes in PTSD symptoms(PCL)	Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat	1. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat
Probable PTSD diagnosis(CAPS)	Four months after combat	Four months after combat

Secondary Outcome Measures

Name	Time	Method
Changes in Depression(PHQ-9)) and Anxiety(STAI)	Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat	1. Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat

Trial Locations

Locations (1)

IDF Military camps; 🇮🇱 Beer sheva, Israel