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

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Active ABMT8
* Behavioral: Active ABMT4
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: combat soldiers Exclusion Criteria: Fluent Hebrew

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active ABMT8<br>Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance | Behavioral: Active ABMT8<br>* Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance<br>|
| Active Comparator: Active ABMT4<br>Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance | Behavioral: Active ABMT4<br>* Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance<br>|
| No Intervention: Control<br>Control: will not receive any intervention | |
| Placebo Comparator: Placebo<br>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 | Behavioral: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combat, Attention bias modification, resilience, PTSD, Depression, Anxiety