Gaze Contingent Attentional Reinforcement in Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aversive white noise, Music reward.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gaze Contingent Attentional Reinforcement Treatment of MDD
Overview
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).
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).
Interventions
- 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. - 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.
Primary outcome measures
- MADRS- diagnostic interview scores [Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up]
Secondary outcome measures (1)
- PHQ-9 - self report measure [Time frame: Post-treatment (1 week after treatment completion) and 3-month follow up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Tel Aviv University — Tel Aviv
Identifiers
NCT: NCT07364981 · TAU-MDD