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Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Sponsor
Tel Aviv University (Other)
Overall Status
Completed
CT.gov ID
NCT02945735
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
26
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attention Modification
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Gaze Contingent Feedback in Major Depressive Disorder
Actual Study Start Date :
Nov 6, 2016
Actual Primary Completion Date :
Jan 7, 2019
Actual Study Completion Date :
Jan 7, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis [approximately 20 min]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tel-Aviv University Tel-Aviv Israel

Sponsors and Collaborators

  • Tel Aviv University

Investigators

  • Principal Investigator: Yair Bar-Haim, Phd, Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yair Bar-Haim, Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT02945735
Other Study ID Numbers:
  • TAUDEPI
First Posted:
Oct 26, 2016
Last Update Posted:
Dec 18, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Yair Bar-Haim, Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University, Tel Aviv University
depression
cognitive bias modification
MDD
major depressive disorder
attention bias modification treatment
Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major

Study Results

No Results Posted as of Dec 18, 2019