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Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Primary Purpose

Depression, Unipolar, Depressive Disorder, Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Modification
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Unipolar focused on measuring depression, cognitive bias modification, MDD, major depressive disorder, attention bias modification treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel-Aviv University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gaze-contingent

non-gaze contingent

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 25, 2016
Last Updated
December 17, 2019
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02945735
Brief Title
Gaze Contingent Feedback in Major Depressive Disorder (MDD)
Official Title
Gaze Contingent Feedback in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2016 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unipolar, Depressive Disorder, Depressive Disorder, Major
Keywords
depression, cognitive bias modification, MDD, major depressive disorder, attention bias modification treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaze-contingent
Arm Type
Experimental
Arm Description
Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns
Arm Title
non-gaze contingent
Arm Type
Placebo Comparator
Arm Description
Participants will receive non-gaze-continent feedback unrelated to their viewing patterns
Intervention Type
Behavioral
Intervention Name(s)
Attention Modification
Intervention Description
Feedback according to participants' viewing patterns, in order to modify their attention.
Primary Outcome Measure Information:
Title
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
Description
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.
Time Frame
post treatment (1 week after treatment completion) and 3-month follow up
Secondary Outcome Measure Information:
Title
Change from baseline - BDI-II - Beck Depression Inventory
Description
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.
Time Frame
post treatment (1 week after treatment completion) and 3-month follow up
Other Pre-specified Outcome Measures:
Title
changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
Description
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.
Time Frame
approximately 20 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, Phd
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Gaze Contingent Feedback in Major Depressive Disorder (MDD)

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