Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification

Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attention bias modification interventions aimed at enhancing soldiers' mental resilience, it is essential to test the efficiency of such training programs in RCTs. The purpose of the current study is to examine the efficiency of a new attention eye-tracking-based training protocol, in comparison to an RT-based training protocol, and to a control group, in reducing risk for post-trauma symptoms in combat deployed soldiers.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; PTSD; Anxiety Disorders
• Intervention / Treatment: Behavioral: Gaze-Contingent Feedback Training; Behavioral: Attention Bias Modification; Behavioral: Neutral Control

Detailed Description

Following the explanation to participants regarding the study process, those who give written consent to participate will be randomly placed into one of three groups: GCFT (N=180), ABMT (N=180), and a neutral control group - RT-based task (N=180). The study will include 3 measurement points: before attention training (in basic training before deployment), after attention training (in basic training camp, still before deployment), and after a combat deployment cycle (6-12 months - to be determined based on the military deployment mission of the participants). In each measurement point, the participants will complete computerized tasks to measure attention and will complete self-report questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 6997801
    • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Each soldier from the allocated cohort who gives written consent will be able to participate in the study.

Exclusion Criteria:

• Hebrew proficiency is insufficient to complete the study questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gaze-Contingent Feedback Training (toward threat); In the task, 30 different matrices, each consisting of 16 faces, will be presented. Each matrix includes 8 angry faces and 8 neutral, 8 women and 8 men, and the locations are counterbalanced between matrices. The participants are asked to view the matrices in any way they choose, and the eye-tracking camera records their viewing location relative to the stimuli presented on the screen. At the beginning of each training session, the soldier will choose to which music he would like to listen during the 12-minute session from a diverse list of music. After calibrating the eye-tracker, the participant will be instructed to view matrices of faces as he chooses, as described above in the assessment task. The music chosen by the participant will play only when he is looking at threatening faces and it will stop when he looks at neutral faces. Thus, a change in viewing patterns is expected by implementing operant conditioning principles.	Behavioral: Gaze-Contingent Feedback Training; Feedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli.
Active Comparator: RT-Based Attention Bias Modification (toward threat); A dot-probe task of 160 trials. Trials begins with a fixation cross (+), on which the participant is asked to focus (500ms). Then two face stimuli (one angry one neutral) are presented above and below the fixation cross (500ms). After the stimuli disappear, a target probe (right- or left-pointing arrowhead) appears in place of one of the face stimuli. The participant is asked to indicate which target probe was presented using a predetermined key. The target probe will remain on the screen until response, after which a new trial will begin. Participants are instructed to identify the probe type as quickly and accurately as possible. In the training task, all of the target probes will appear in the threat location (angry face). Thus, over multiple trials, learning is expected to occurs such that the threatening face predicts the location of the target probe, thereby achieving the desired change in attention pattern.	Behavioral: Attention Bias Modification; Attention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli.
Placebo Comparator: Neutral Control; This condition is also based on the dot-probe task (see Active Comparator) with a fundamental difference. In this task, only neutral faces will be displayed, and therefore, while participants are exposed to the same task parameters, there will be no attention training and there will be no exposure to threat stimuli.	Behavioral: Neutral Control; Dot-probe task using only neutral stimuli with no training toward threat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Combat PTSD Symptoms	Score on on self-report questionnaire Posttraumatic stress disorder checklist for DSM-5 (PCL-5). The total score, ranging from 0 to 80, reflects PTSD symptom severity, with higher scores representing greater severity.	Change from baseline Post-Combat PTSD Symptoms at approximately 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Combat General Anxiety	Score on self-report questionnaire Generalized Anxiety Disorder questionnaire (GAD-7). The total score, ranging from 0 to 21, reflects GAD symptom severity, with higher scores representing greater severity.	Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years
Post-Combat Depression	Score on self-report Patient Health Questionnaire 9 (PHQ-9). The total score, ranging from 0-27, reflects severity of depressive symptoms, with higher scores representing greater severity	Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Training RT-based Attention Bias toward threat	Change in Attention Bias will be assessed with a response-time based dot-probe task.	Change from baseline Attention Bias within 6 months of baseline measurement
Post-Training Subjective Attention Bias toward threat	Change in Subjective Attention Bias will be assessed with a self-reported attention bias using the Attention Bias Questionnaire (ABQ). The total score, ranging from 0 to 36, represents threat-related attention bias, with higher scores representing greater bias toward threat.	Change from baseline Attention Bias within 6 months of baseline measurement
Post-Training Eye-tracking Attention Bias toward threat	Change in Attention Bias will also be assessed with an eye-tracking task.	Change from baseline Attention Bias within 6 months of baseline measurement

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Investigators: Principal Investigator: Yair Bar-Haim, PhD, Tel Aviv University

Publications and helpful links

General Publications

• 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 (Actual): June 30, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Control Trial; Attention Bias Modification; Eye-tracking
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: TAU-GCFTresilience

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No