NCT05306197

Brief Summary

Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attentional interventions aimed at enhancing soldiers' combat performance, it is essential to extensively investigate the efficiency of these training programs, which has yet to been done. The prupose of the current study is to examine the efficiency of the new attention eye-tracking based training, in comparison to RT-based training and to a control group, in improving performance of combat soldiers. In addition, the influence of the attention training on aspects of psychological resilience will also be examined in questionnaires.

Trial Health

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Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

March 22, 2022

Last Update Submit

July 8, 2024

Conditions

Keywords

Attention Bias ModificationRandomized Control TrialEye-tracking

Outcome Measures

Primary Outcomes (1)

  • Change in Combat Performance

    Composite scores for Static marksmanship, simulator shooting performance (Bagira), running test grades, and obstacle course grades will be gathered from soldiers' commanders before and after intervention sessions to test for change.

    Approximately 3 months after baseline

Secondary Outcomes (3)

  • Post-Combat Trauma

    Change from baseline Post-Combat PTSD Symptoms at approximately 3 months

  • Post-Combat General Anxiety

    Change from baseline Post-Combat General Anxiety Symptoms at approximately 3 months

  • Post-Combat Depression

    Change from baseline Post-Combat Depression Symptoms at approximately 3 months

Other Outcomes (3)

  • Post-Training RT-based Attention Bias toward threat

    Change from baseline Attention Bias within 3 months of baseline measurement

  • Post-Training Subjective Attention Bias toward threat

    Change from baseline Attention Bias within 3 months of baseline measurement

  • Post-Training Eye-tracking Attention Bias toward threat

    Change from baseline Attention Bias within 3 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

Active Comparator: 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

Non-Contingent Feedback Training

PLACEBO COMPARATOR

This condition is also based on the eye-tracking task (see Experimental Arm) with a fundamental change - The music chosen by the soldier will play continuously without any reinforcement for looking at threat or neutral faces.

Behavioral: Non-Contingent Feedback Training

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.

Active Comparator: RT-Based Attention Bias Modification (toward threat)

Participants listen to a musical track they chose with no operant conditioning.

Non-Contingent Feedback Training

Eligibility Criteria

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

You may qualify if:

  • Each soldier from the cohort that will give his 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

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
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 1, 2022

Study Start

March 14, 2022

Primary Completion

February 27, 2024

Study Completion

June 21, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations