Gaze Contingent Attentional Reinforcement in Major Depressive Disorder

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).

• 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

• MADRS- diagnostic interview scores [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

• PHQ-9 - self report measure [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

• Attention Allocation [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).
• M.I.N.I diagnosis- diagnostic interview [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.

Sex: All, ages: 18 Years to 65 Years

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

• Amit Lazarov, PhD, Principal investigator, Tel Aviv University