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Trial record 2 of 1327 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Change

Gaze Contingent Feedback in Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT02945735
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, 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)

Condition or disease Intervention/treatment Phase
Depression, Unipolar Depressive Disorder Depressive Disorder, Major Behavioral: Attention Modification Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945735


Contacts
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Contact: Yair Bar-Haim, PhD yair1@post.tau.ac.il
Contact: Dana Shamai, BA danasham@mail.tau.ac.il

Locations
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Israel
Tel-Aviv University Recruiting
Tel-Aviv, Israel
Contact: Yair Bar-Haim, PhD       yair1@post.tau.ac.il   
Contact: Dana Shamai       danasham@mail.tau.ac.il   
Principal Investigator: Yair Bar-Haim, PhD         
Sub-Investigator: Dana Shamai         
Sponsors and Collaborators
Tel Aviv University
Investigators
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Principal Investigator: Yair Bar-Haim, Phd Tel Aviv University

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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     History of Changes
Other Study ID Numbers: TAUDEPI
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yair Bar-Haim, Tel Aviv University:
depression
cognitive bias modification
MDD
major depressive disorder
attention bias modification treatment
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders