Gaze Contingent Feedback in Major Depressive Disorder (MDD)

NCT02945735 | Completed

• 1 other identifier: TAUDEPI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Depression, Unipolar; Depressive Disorder; Depressive Disorder, Major

Keywords

depression; cognitive bias modification; MDD; major depressive disorder; attention bias modification treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline - BDI-II - Beck Depression Inventory

  post treatment (1 week after treatment completion) and 3-month follow up

Other Outcomes (1)

• changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis

  approximately 20 min

Study Arms (2)

gaze-contingent

EXPERIMENTAL

Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns

Behavioral: Attention Modification

non-gaze contingent

PLACEBO COMPARATOR

Participants will receive non-gaze-continent feedback unrelated to their viewing patterns

Behavioral: Attention Modification

Interventions

Attention Modification BEHAVIORAL

Feedback according to participants' viewing patterns, in order to modify their attention.

gaze-contingent; non-gaze contingent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Yair Bar-Haim, Phd

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: November 6, 2016
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)