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

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Active ABMT8; Behavioral: Active ABMT4; Behavioral: Placebo

• Study Type: Interventional
• Enrollment (Actual): 862
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer sheva, Israel
    • IDF Military camps

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• combat soldiers

Exclusion Criteria:

• Fluent Hebrew

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Bias Scores	Attention bias scores measured in milliseconds using the dot-probe task	Pre-traetment baseline and in deployment

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Collaborators: Walter Reed Army Institute of Research (WRAIR); Medical Corps, Israel Defense Force
• Investigators: Principal Investigator: Eyal Fruchter, Mental Health Department IDF

Publications and helpful links

General Publications

• Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.
• Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.
• Wald I, Fruchter E, Ginat K, Stolin E, Dagan D, Bliese PD, Quartana PJ, Sipos ML, Pine DS, Bar-Haim Y. Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2627-36. doi: 10.1017/S0033291716000945. Epub 2016 Jul 5.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: PTSD; Depression; Anxiety; resilience; combat; Attention bias modification
• Other Study ID Numbers: TelAvivU