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NCT Number: NCT07364981

Gaze Contingent Attentional Reinforcement in Major Depressive Disorder

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aversive white noise

Behavioral

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.

Music reward

Behavioral

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.

Primary outcomes

  1. MADRS- diagnostic interview scores

    Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up

    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.

Secondary outcomes

  1. PHQ-9 - self report measure

    Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up

    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.

Other outcomes

  1. Attention Allocation

    Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up

    Changes from baseline- attention allocation towards the target stimuli (happy faces) compared to the non-target stimuli (sad faces).

  2. M.I.N.I diagnosis- diagnostic interview

    Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shani Lavi, M.A.

CONTACT

[email protected]

+972 50 2656664

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Gaze Contingent Attentional Reinforcement Treatment of MDD

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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