Back to resultsIncreasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Primary Purpose
PTSD, Depression, Anxiety Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gaze-Contingent Feedback Training
Attention Bias Modification
Neutral Control
Sponsored by
About this trial
This is an interventional prevention trial for PTSD focused on measuring Attention Bias Modification, Eye-tracking, Randomized Control Trial
Eligibility Criteria
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.
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Gaze-Contingent Feedback Training (toward threat)
RT-Based Attention Bias Modification (toward threat)
Neutral Control
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05294848
Brief Title
Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Official Title
Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Anxiety Disorders
Keywords
Attention Bias Modification, Eye-tracking, Randomized Control Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel random assignment to 3 arms in 1:1:1 ratio.
Masking
Participant
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gaze-Contingent Feedback Training (toward threat)
Arm Type
Experimental
Arm Description
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.
Arm Title
RT-Based Attention Bias Modification (toward threat)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neutral Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gaze-Contingent Feedback Training
Intervention Description
Feedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification
Intervention Description
Attention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Control
Intervention Description
Dot-probe task using only neutral stimuli with no training toward threat
Primary Outcome Measure Information:
Title
Post-Combat PTSD Symptoms
Description
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.
Time Frame
Change from baseline Post-Combat PTSD Symptoms at approximately 1.5 years
Secondary Outcome Measure Information:
Title
Post-Combat General Anxiety
Description
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.
Time Frame
Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years
Title
Post-Combat Depression
Description
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
Time Frame
Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years
Other Pre-specified Outcome Measures:
Title
Post-Training RT-based Attention Bias toward threat
Description
Change in Attention Bias will be assessed with a response-time based dot-probe task.
Time Frame
Change from baseline Attention Bias within 6 months of baseline measurement
Title
Post-Training Subjective Attention Bias toward threat
Description
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.
Time Frame
Change from baseline Attention Bias within 6 months of baseline measurement
Title
Post-Training Eye-tracking Attention Bias toward threat
Description
Change in Attention Bias will also be assessed with an eye-tracking task.
Time Frame
Change from baseline Attention Bias within 6 months of baseline measurement
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
6997801
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27377418
Citation
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.
Results Reference
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Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
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