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

Sponsor
Tel Aviv University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05294848
Collaborator
(none)
540
1
3
23
23.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gaze-Contingent Feedback Training
  • Behavioral: Attention Bias Modification
  • Behavioral: Neutral Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel random assignment to 3 arms in 1:1:1 ratio.Parallel random assignment to 3 arms in 1:1:1 ratio.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-Combat PTSD Symptoms [Change from baseline Post-Combat PTSD Symptoms at approximately 1.5 years]

    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.

Secondary Outcome Measures

  1. Post-Combat General Anxiety [Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years]

    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.

  2. Post-Combat Depression [Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years]

    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

Other Outcome Measures

  1. Post-Training RT-based Attention Bias toward threat [Change from baseline Attention Bias within 6 months of baseline measurement]

    Change in Attention Bias will be assessed with a response-time based dot-probe task.

  2. Post-Training Subjective Attention Bias toward threat [Change from baseline Attention Bias within 6 months of baseline measurement]

    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.

  3. Post-Training Eye-tracking Attention Bias toward threat [Change from baseline Attention Bias within 6 months of baseline measurement]

    Change in Attention Bias will also be assessed with an eye-tracking task.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tel Aviv University Tel Aviv Israel 6997801

Sponsors and Collaborators

  • Tel Aviv University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yair Bar-Haim, Professor, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT05294848
Other Study ID Numbers:
  • TAU-GCFTresilience
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yair Bar-Haim, Professor, Tel Aviv University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022