Gaze Contingent Attentional Reinforcement in Major Depressive Disorder

Gaze Contingent Attentional Reinforcement Treatment of MDD

The main objective of this randomized controlled trial is to evaluate whether a gaze-contingent feedback task using negative reinforcement can serve as an effective attention-modification procedure and contribute to the treatment of Major Depressive Disorder (MDD).

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Behavioral: Aversive white noise; Behavioral: Music reward

Detailed Description

This randomized controlled trial uses a gaze-contingent attentional reinforcement task to modify attention allocation patterns to emotional stimuli in participants with Major Depressive Disorder. Specifically, participants will undergo 4 training sessions, during which either negative reinforcement (aversive white noise will be heard when gazing at sad faces) or positive reinforcement (music will be heard when gazing at happy faces) will be used to divert participants' gaze toward happy faces and away from sad faces. Depressive symptoms severity will be assessed before and after training (post-training and 3-month follow up) to examine changes (reduction) in symptom severity from before to after the intervention. Attention allocation will be assessed during training (i.e. online learning) as well as before and after training (i.e. transfer of learning).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shani Lavi, M.A.; Phone Number: +972 50 2656664; Email: shanilavi@mail.tau.ac.il

Study Locations

• Israel
  • Tel Aviv, Israel, 6997801
    • Tel Aviv University
    • Contact: Shani Lavi, M.A.; Phone Number: +972 50 2656664; Email: shanilavi@mail.tau.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary diagnosis of MDD
• MADRS>=7
• Normal or corrected-t-normal vision

Exclusion Criteria:

• Present or past psychosis, manic or hypomanic episode, PTSD
• High suicidal ideation or behavior
• Severe alcohol or cannabis use disorder, and/or any severity of other substance use disorder (exepct nicotine use)
• Pharmacological treatment if not stabilized for at least three months or concurrent psychotherapy
• Current unstable or untreated medical illness
• Current or past organic mental disorder, seizure or brain injury
• Eye-tracking calibration difficulties
• Post-ECT treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gaze contingent negative reinforcement; participants will receive gaze-contingent negative reinforcement according to their viewing patterns	Behavioral: Aversive white noise; Participants will receveve gaze-contingent negative-reinforcement feedback according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the noise will stop.
Placebo Comparator: Gaze contingent positive reinforcement; participants will receive gaze-contingent positive reinforcement according to their viewing patterns	Behavioral: Music reward; Participants will receive gaze-contingent music-reward according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the music will play.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS- diagnostic interview scores	Change from baseline- the Montgomery Asberg Depression Rating scale is a clinician-administered scale that includes 10 items that measure the severity of depressive symptoms. Each of the 10 items is scored on a 7-point scale (0-6). The total score, ranging from 0 to 60 is used to assess severity.	Post-treatment (1 week after treatment completion) and 3-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9 - self report measure	Change from baseline- the Patient Health Questionnaire-9 is a nine-question self-report questionnaire to assess the severity of depression based on symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The overal score ranges from 0-27, indicating depression severity.	Post-treatment (1 week after treatment completion) and 3-month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Allocation	Changes from baseline- attention allocation towards the target stimuli (happy faces) compared to the non-target stimuli (sad faces).	Post-treatment (1 week after treatment completion) and 3-month follow up
M.I.N.I diagnosis- diagnostic interview	Changes in the Mini-International Neuropsychiatric Interview diagnosis. The M.I.N.I. is a structured diagnostic interview for DSM-5 and ICD-11 psychiatric disorders.	Post-treatment (1 week after treatment completion) and 3-month follow up

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Investigators: Principal Investigator: Amit Lazarov, PhD, Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: MDD; negative reinforcement; positive reinforcement; attention allocation
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: TAU-MDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No