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

NCT05243459 | Terminated Phase 2

• 1 other identifier: TAU-GCFTveterans
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• 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

  1.5-2 months

• Clinician-rated PTSD symptoms at 3-month Follow-up

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

  3 Months after treatment completion

• 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

  1.5-2 months

• PTSD Diagnosis at 3-month Follow-up

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

  3 Months after treatment completion

Secondary Outcomes (6)

• Change in Patient-rated PTSD symptoms from Pre- to Post-Treatment

  1.5-2 months

• Patient-rated PTSD symptoms at 3-month Follow-up

  3 Months after treatment completion

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

  1.5-2 months

• Patient-rated Depression symptoms at 3-month Follow-up

  3 Months after treatment completion

• Pre-treatment Clinical Global Impression Scale

  Up to 2 weeks pre-treatment

Other Outcomes (6)

• Change in behavioral Attention Bias from Baseline to Post-treatment

  1.5-2 months

• Behavioral Attention Bias at 3-month Follow-up

  3 Months after treatment completion

• Change in behavioral Attention Control from Baseline to Post-treatment

  1.5-2 months

Study Arms (3)

Gaze-Contingent Feedback Training

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 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.

Behavioral: Gaze-Contingent Feedback Training

RT-Based Attention Bias Modification

ACTIVE COMPARATOR

The 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.

Behavioral: Attention Bias Modification

Non-Contingent Feedback Training

PLACEBO COMPARATOR

This 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.

Behavioral: Non-Contingent Feedback Training

Interventions

Gaze-Contingent Feedback Training BEHAVIORAL

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

Gaze-Contingent Feedback Training

Attention Bias Modification BEHAVIORAL

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

RT-Based Attention Bias Modification

Non-Contingent Feedback Training BEHAVIORAL

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.

Non-Contingent Feedback Training

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

Related Publications (1)

• 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.

  PMID: 28103714 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 17, 2022
• Study Start: June 30, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)