NCT05294848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

March 8, 2022

Last Update Submit

April 8, 2025

Conditions

Keywords

Attention Bias ModificationEye-trackingRandomized Control Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Post-Combat General Anxiety

    Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years

  • Post-Combat Depression

    Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years

Other Outcomes (3)

  • Post-Training RT-based Attention Bias toward threat

    Change from baseline Attention Bias within 6 months of baseline measurement

  • Post-Training Subjective Attention Bias toward threat

    Change from baseline Attention Bias within 6 months of baseline measurement

  • Post-Training Eye-tracking Attention Bias toward threat

    Change from baseline Attention Bias within 6 months of baseline measurement

Study Arms (3)

Gaze-Contingent Feedback Training (toward threat)

EXPERIMENTAL

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

RT-Based Attention Bias Modification (toward threat)

ACTIVE COMPARATOR

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

Neutral Control

PLACEBO COMPARATOR

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

Interventions

Feedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli.

Gaze-Contingent Feedback Training (toward threat)

Attention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli.

RT-Based Attention Bias Modification (toward threat)
Neutral ControlBEHAVIORAL

Dot-probe task using only neutral stimuli with no training toward threat

Neutral Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hebrew proficiency is insufficient to complete the study questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

Related Publications (1)

  • 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.

    PMID: 27377418BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel random assignment to 3 arms in 1:1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 24, 2022

Study Start

June 30, 2021

Primary Completion

August 14, 2023

Study Completion

June 21, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations