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Completed

NCT Number: NCT02945735

Gaze Contingent Feedback in Major Depressive Disorder (MDD)

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)

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Key information

Conditions

Depression, Unipolar Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv University

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

attention modification

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Gaze Contingent Feedback in Major Depressive Disorder

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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