Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Overview

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)

Full Title of Study: “Gaze Contingent Feedback in Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 7, 2019

Detailed Description

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.

Interventions

  • Behavioral: Attention Modification
    • Feedback according to participants’ viewing patterns, in order to modify their attention.

Arms, Groups and Cohorts

  • Experimental: gaze-contingent
    • Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns
  • Placebo Comparator: non-gaze contingent
    • Participants will receive non-gaze-continent feedback unrelated to their viewing patterns

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline – Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
    • Time Frame: post treatment (1 week after treatment completion) and 3-month follow up
    • 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.

Secondary Measures

  • Change from baseline – BDI-II – Beck Depression Inventory
    • Time Frame: post treatment (1 week after treatment completion) and 3-month follow up
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel Aviv University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yair Bar-Haim, Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University – Tel Aviv University
  • Overall Official(s)
    • Yair Bar-Haim, Phd, Principal Investigator, Tel Aviv University

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