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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gaze contingent negative reinforcement | Active Comparator | participants will receive gaze-contingent negative reinforcement according to their viewing patterns |
|
| Gaze contingent positive reinforcement | Placebo Comparator | participants will receive gaze-contingent positive reinforcement according to their viewing patterns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shani Lavi, M.A. | Contact | +972 50 2656664 | shanilavi@mail.tau.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Amit Lazarov, PhD | Tel Aviv University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv University | Tel Aviv | 6997801 | Israel |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| 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. |
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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 |