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Posttraumatic Stress DisorderPhase 2/3NCT05243459

Testing the Efficacy of an Eye-tracking-based Treatment in Reducing Stress-related Symptoms in Veterans With PTSD

A Phase 2/3 study testing Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training in people with Posttraumatic Stress Disorder, run by Tel Aviv University at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study will examine the efficacy of a feedback-based treatment applying eye-tracking (Gaze-Contingent Music Reward Therapy) to change attention and gaze patterns associated with angry faces relative to a response-time-based attention bias modification treatment applying the dot-probe task and a control group. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
1 siteIsrael
Study dates
30 Jun 2021to 31 Jul 2025
Phase
Phase 2/3
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of PTSD according to the DSM-5 and related to military service, ages 20-70

Who cannot join

  • Psychotic or Bipolar disorder, drug and alcohol abuse, high risk of harming self or others, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Tel Aviv University

    Tel Aviv, 6997801

Other trials in Israel

About this study

The study will examine the efficacy of a feedback-based treatment applying eye-tracking (Gaze-Contingent Music Reward Therapy) to change attention and gaze patterns associated with angry faces relative to a response-time-based attention bias modification treatment applying the dot-probe task and a control group.

Read the detailed description

The study will recruit veterans with posttraumatic stress disorder (PTSD) due to a trauma acquired during military service. A compatibility check and initial filtering will happen via phone call, using basic symptom questionnaires for self-report and initial examination of exclusion criteria.

This study has four phases:

  1. Clinical Assessment - Participants who pass the initial filtering and express a desire to participate in the study will be invited to a structured clinical interview during which clinical and practical inclusion and exclusion criteria will be examined by an independent evaluator (a clinical psychologist). After an explanation about the study and provision of signed informed consent from the participant, the clinical interview (CAPS-5 and MINI) will be conducted and self-report questionnaires will be completed:
  • Post-trauma Checklist (PCL) - PTSD symptoms
  • Patient Health Questionnaire (PHQ) - Depression Symptoms
  • Attention Bias Questionnaire (ABQ) - Attention Patterns
  • Attention Control Scale (ACS) - Attention Control
  1. Attention bias measurement - participants will perform computerized tasks aimed to measure their attention bias prior to treatment.
  • Free viewing of 30 matrices each with 16 faces (8 with neutral facial expression and 8 with angry facial expression) while monitoring gaze location with passive eye-tracking technology - duration of this assessment is about 15 minutes.
  • Attention bias measurement using a dot-probe task in which two faces are presented on the screen and replaced by an arrow pointing right or left, and the participant has to indicate the arrow's direction by pressing a key - duration of the task is about 5 minutes.
  • Generic Flanker attention task, in which a middle arrow is presented with additional arrows to the right and left (for example <<><< or >>>>>) and the participant is asked to identify the direction of the middle arrow by pressing a key - duration of the task is about 5 minutes.
  1. Attention Training - Next participants will be randomly assigned to one of three groups.
  • 8 sessions of Gaze Contingent Music Reward Therapy (GC-MRT) - In every session, the participant chooses music to which to listen and is then asked to view matrices of 16 faces as described above. The music plays when the participant views neutral faces and stops when viewing angry faces - each meeting lasts about 20 minutes.
  • 8 sessions of Attention Bias Modification Treatment based on a dot-probe task described above with one difference: While in the assessment task the probe location is counterbalanced at neutral and angry faces locations, in the treatment task the arrow always appears at the neutral face location - each session takes about 20 minutes.
  • Control group in which participants are exposed to the same procedure as GC-MRT but the music will play continually without contingency to participant's gaze.
  1. Post-Training Assessment and Measurements - After the 8 treatment sessions, participants will undergo another clinical interview and the same questionnaires and attention assessment tasks similar to those conducted before the treatment. The clinical interview, questionnaires, and attention measurements will occur again after three months from the end of treatment (follow-up).
  • NOTE: As a direct result of the ongoing war in Israel the study has encountered serious difficulties in veteran-patients recruitment. First, many veterans were called into active duty since October 7th, 2023, limiting their availability for treatment/research. Second, with the war, numerous new treatment options have become available for veterans with PTSD, making it extremely difficult to recruit patients into a trial.

To date (March 18, 2025), 113 (target n=150) veterans have enrolled in the study and started treatment. Blinded group sizes from stratified randomization thus far stand at 39, 38, and 36.

Given this situation, we are forced to terminate the study early on June 1st, 2025. We will enroll as many additional participants as possible until this end-date.

Being tested
Gaze-Contingent Feedback Training, Attention Bias Modification, Non-Contingent Feedback Training
Medical subject headings
Stress Disorders, Post-Traumatic

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 away from threat face stimuli.

  • Attention Bias ModificationBehavioural

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

  • Non-Contingent Feedback TrainingBehavioural

    Participants listen to a musical track they chose while viewing the face matrices. The music is played throughout and is not contingent upon gaze behavior.

Study groups in NCT05243459
Study groupRoleWhat they receive
Gaze-Contingent Feedback TrainingExperimentalIn 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 veteran 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-tracking technology, the veteran will be instructed to view the matrices of faces as he chooses, as described above in the assessment task. The music chosen by the veteran will play only when s/he is looking at neutral faces and it will stop when s/he looks at threatening faces.
Receives: Behavioral: Gaze-Contingent Feedback Training
RT-Based Attention Bias ModificationActive comparatorThe task consists of 160 trials. Each trial begins with a centrally-presented fixation cross (+), on which the participant is asked to focus for 500ms. When it disappears, two stimuli will be presented 1.5cm above and below the previous fixation cross for 500ms. After the stimuli disappear, a target probe (right- or left-pointing arrowhead) will appear in place of one of the stimuli, and the participant will be asked to indicate which target probe is presented by pressing the respective key. The target probe will remain on the screen until the participant's 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 neutral face location. Thus, over multiple trials, learning occurs that the threatening face predicts the location of the target probe, thereby achieving the desiring change in attention patterns.
Receives: Behavioral: Attention Bias Modification
Non-Contingent Feedback TrainingPlacebo comparatorThis condition is based on the aforementioned eye-tracking task with a fundamental change - The music chosen by the veteran 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.

  1. Change in Clinician-rated PTSD symptoms from Pre- to Post-Treatment

    Change in total score on the Clinician Administered PTSD Scale (CAPS-5) from pre- to post-treatment

    Measured: 1.5-2 months

  2. Clinician-rated PTSD symptoms at 3-month Follow-up

    Total score on the Clinician Administered PTSD Scale (CAPS-5) at 3-month Follow-up

    Measured: 3 Months after treatment completion

  3. Change in PTSD Diagnosis from Pre- to Post-Treatment

    Change in PTSD diagnosis, derived from CAPS-5 corresponding to DSM-5 criteria, from pre- to post-treatment

    Measured: 1.5-2 months

  4. PTSD Diagnosis at 3-month Follow-up

    PTSD diagnosis derived from CAPS-5 corresponding to DSM-5 criteria at 3-month Follow-up

    Measured: 3 Months after treatment completion

Secondary outcomes (6)
  1. Change in Patient-rated PTSD symptoms from Pre- to Post-Treatment

    Change in score on self-report questionnaire Posttraumatic stress disorder checklist for DSM-5 (PCL-5) from Pre- to Post-Treatment. The total score, ranging from 0 to 80, reflects PTSD symptom severity, with higher scores representing greater severity.

    Measured: 1.5-2 months

  2. Patient-rated PTSD symptoms at 3-month Follow-up

    Score on self-report questionnaire Posttraumatic stress disorder checklist for DSM-5 (PCL-5) at 3-month Follow-up. The total score, ranging from 0 to 80, reflects PTSD symptom severity, with higher scores representing greater severity.

    Measured: 3 Months after treatment completion

  3. Change in Patient-rated Depression symptoms from Pre- to Post-Treatment

    Change in Score on self-report Patient Health Questionnaire 9 (PHQ-9) from Pre- to Post-Treatment. The total score, ranging from 0-27, reflects severity of depressive symptoms, with higher scores representing greater severity.

    Measured: 1.5-2 months

  4. Patient-rated Depression symptoms at 3-month Follow-up

    Score on self-report Patient Health Questionnaire 9 (PHQ-9) at 3-month Follow-up. The total score, ranging from 0-27, reflects severity of depressive symptoms, with higher scores representing greater severity.

    Measured: 3 Months after treatment completion

  5. Pre-treatment Clinical Global Impression Scale

    Clinician Rated Symptom Severity \& Improvement. Severity and improvement scales (CGI-S/I) will be used to assess participants global clinical condition. The CGI-S and the CGI-I are single-items, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale. The CGI-S/I has good inter-rater reliability and concurrent validity with other measures. This tool is widely used in clinical trials concerning psychopathology treatments and has good sensitivity to clinical change.

    Measured: Up to 2 weeks pre-treatment

  6. Post-treatment Clinical Global Impression Scale

    Clinician Rated Symptom Severity \& Improvement. Severity and improvement scales (CGI-S/I) will be used to assess participants global clinical condition. The CGI-S and the CGI-I are single-items, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale. The CGI-S/I has good inter-rater reliability and concurrent validity with other measures. This tool is widely used in clinical trials concerning psychopathology treatments and has good sensitivity to clinical change.

    Measured: 1-2 weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start30 Jun 2021
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Why it stopped: Due to the war that is taking place in Israel since October 7, 2023 and the high rates of active army reserve service among the population of the study.

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243459
Sponsor's protocol ID
TAU-GCFTveterans
Status last verified
Sep 2025
First submitted
27 Jan 2022
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lazarov A, Pine DS, Bar-Haim Y. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Am J Psychiatry. 2017 Jul 1;174(7):649-656. doi: 10.1176/appi.ajp.2016.16080894. Epub 2017 Jan 20.

    PubMed 28103714

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gaze-Contingent Feedback Training, Attention Bias Modification and Non-Contingent Feedback Training in people with Posttraumatic Stress Disorder, 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 8 Sep 2025. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the war that is taking place in Israel since October 7, 2023 and the high rates of active army reserve service among the population of the study.). 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 Clinician-rated PTSD symptoms from Pre- to Post-Treatment (time frame: 1.5-2 months). The study lists 4 primary outcomes in all. 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 NCT05243459, 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 8 Sep 2025.

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