Military Combat PerformanceNCT05306197
Improving Performance of Combat Soldiers by Utilizing Attentional Training Based on Eye Tracking
A study testing Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training in people with Military Combat Performance, run by Tel Aviv University at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Military Combat Performance
- What is being tested?
- Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Mar 2022to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each soldier from the cohort that will give his written consent will be able to participate in the study.
Who cannot join
- Hebrew proficiency is insufficient to complete the study questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Performance of Combat Soldiers by Utilizing Attentional Training Based on Eye Tracking - Improvement of Combat Performance
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.
Read the 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=60), ABMT (N=60), and a neutral control group - task based on eye-tracking (N=60). The study will include 2 measurement points during the military service: before the attention training and after the attention training. In each measurement point, the soldiers will complete computerized tasks to measure threat attention, questionnaires, and performance data from shooting ranges and combat fitness.
- Conditions
- Military Combat Performance
- Being tested
- Gaze-Contingent Feedback Training, Attention Bias Modification, Non-Contingent Feedback Training
- Keywords
- Attention Bias Modification, Randomized Control Trial, Eye-tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze-Contingent Feedback TrainingBehavioural
Feedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli.
Attention Bias ModificationBehavioural
Attention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli.
Non-Contingent Feedback TrainingBehavioural
Participants listen to a musical track they chose with no operant conditioning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Non-Contingent Feedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 months after baseline
Secondary outcomes (3)
Post-Combat Trauma
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.
Measured: Change from baseline Post-Combat PTSD Symptoms at approximately 3 months
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.
Measured: Change from baseline Post-Combat General Anxiety Symptoms at approximately 3 months
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.
Measured: Change from baseline Post-Combat Depression Symptoms at approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start14 Mar 2022
- Primary completion27 Feb 2024
- Study completion21 Jun 2024
Why it stopped: Due to deteriorating operative and security conditions in the country, we were unable to continue meeting with the troops for data collection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Military Combat PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306197
- Sponsor's protocol ID
- TAU-GCFTperformance
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27377418
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Performance of Combat Soldiers by Utilizing Attentional Training Based on Eye Tracking - Improvement of Combat Performance
- ClinicalTrials.gov ID
- NCT05306197
- Acronym / sponsor ID
- TAU-GCFTperformance
- Conditions
- Military Combat Performance
- Keywords
- Attention Bias Modification, Randomized Control Trial, Eye-tracking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to deteriorating operative and security conditions in the country, we were unable to continue meeting with the troops for data collection.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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=60), ABMT (N=60), and a neutral control group - task based on eye-tracking (N=60). The study will include 2 measurement points during the military service: before the attention training and after the attention training. In each measurement point, the soldiers will complete computerized tasks to measure threat attention, questionnaires, and performance data from shooting ranges and combat fitness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gaze-Contingent Feedback Training (toward threat) | Experimental | Behavioral: Gaze-Contingent Feedback TrainingIn 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. |
| Active Comparator: RT-Based Attention Bias Modification (toward threat) | Active comparator | Behavioral: Attention Bias ModificationA 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. |
| Non-Contingent Feedback Training | Placebo comparator | Behavioral: Non-Contingent Feedback TrainingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Each soldier from the cohort that will give his written consent will be able to participate in the study.
Key exclusion criteria (1 listed)
- Hebrew proficiency is insufficient to complete the study questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaze-Contingent Feedback TrainingFeedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli. | Behavioural | Gaze-Contingent Feedback Training (toward threat) |
| Attention Bias ModificationAttention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli. | Behavioural | Active Comparator: RT-Based Attention Bias Modification (toward threat) |
| Non-Contingent Feedback TrainingParticipants listen to a musical track they chose with no operant conditioning. | Behavioural | Non-Contingent Feedback Training |
Primary outcome
Change in Combat Performance
Time frame: Approximately 3 months after baseline
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.
3 secondary outcomes
Post-Combat Trauma
Time frame: Change from baseline Post-Combat PTSD Symptoms at approximately 3 months
Post-Combat General Anxiety
Time frame: Change from baseline Post-Combat General Anxiety Symptoms at approximately 3 months
Post-Combat Depression
Time frame: Change from baseline Post-Combat Depression Symptoms at approximately 3 months
Results and safety
The study was stopped early (reason given: Due to deteriorating operative and security conditions in the country, we were unable to continue meeting with the troops for data collection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 27377418Wald 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training in people with Military Combat Performance, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to deteriorating operative and security conditions in the country, we were unable to continue meeting with the troops for data collection.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Combat Performance (time frame: Approximately 3 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.