Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Not Applicable

Completed

• Conditions: Depressive Disorder; Depressive Disorder, Major; Depression, Unipolar

• Registration Number: NCT02945735
• Lead Sponsor: Tel Aviv University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Study Start: 2016-11-06
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)	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 Outcome Measures

Name	Time	Method
Change from baseline - BDI-II - Beck Depression Inventory	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.

Trial Locations

Locations (1)

Tel-Aviv University; 🇮🇱 Tel-Aviv, Israel