Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)

Detailed Description
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The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent placebo feedback.

Official Title
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Gaze Contingent Feedback in Major Depressive Disorder

Conditions
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Depression, Unipolar, Depressive Disorder, Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Attention Modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed consent form Men and women between the ages of 18 and 65. Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure. Exclusion Criteria: Psychotic episode in the past or the present time. Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury). Another psychotherapeutic treatment during the study. Usage of neuroleptic medication. Change in medication status during the study. Substantial usage of drugs or alcohol in the present time. Poor judgment capacity (i.e., children under 18 and special populations). High Risk of Suicide.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gaze-contingent<br>Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns | Behavioral: Attention Modification<br>* Feedback according to participants' viewing patterns, in order to modify their attention.<br>|
| Placebo Comparator: non-gaze contingent<br>Participants will receive non-gaze-continent feedback unrelated to their viewing patterns | Behavioral: Attention Modification<br>* Feedback according to participants' viewing patterns, in order to modify their attention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA) | The SIGMA is a ten-item diagnostic structured interview which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on scale ranging from 0 to 6 with a possible total score of 60, with regard to the passing week. | post treatment (1 week after treatment completion) and 3-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline - BDI-II - Beck Depression Inventory | The BDI -II is a 21-question multiple-choice self-report inventory. Each item is rated on scale ranging from 0 to 3, Higher total scores indicate more severe depressive symptoms. | post treatment (1 week after treatment completion) and 3-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, cognitive bias modification, MDD, major depressive disorder, attention bias modification treatment