Gaze Contingent Attentional Reinforcement Treatment of MDD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tel Aviv University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- MADRS- diagnostic interview scores
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Gaze contingent negative reinforcement
participants will receive gaze-contingent negative reinforcement according to their viewing patterns
Intervention: Aversive white noise (Behavioral)
Gaze contingent positive reinforcement
participants will receive gaze-contingent positive reinforcement according to their viewing patterns
Intervention: Music reward (Behavioral)
Outcomes
Primary Outcomes
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
- PHQ-9 - self report measure(Post-treatment (1 week after treatment completion) and 3-month follow up)
Investigators
Amit Lazarov
Professor of Psychology, School of Psychological Sciences
Tel Aviv University