Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Gaze Contingent Feedback in Major Depressive Disorder

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)

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depressive Disorder, Major; Depression, Unipolar
• Intervention / Treatment: Behavioral: Attention Modification

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis	a structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.	approximately 20 min

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2016
• Primary Completion (Actual): January 7, 2019
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: depression; MDD; major depressive disorder; cognitive bias modification; attention bias modification treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: TAUDEPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO