Gaze Contingent Feedback in Major Depressive Disorder (MDD)

Depressive Disorder Clinical Trial

Official title:

Gaze Contingent Feedback in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945735
• Other study ID #: TAUDEPI
• Status: Completed
• Phase: N/A
• Start date: November 6, 2016
• Est. completion date: January 7, 2019

Study information

• Verified date: December 2019
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Behavioral:
• Attention Modification
Feedback according to participants' viewing patterns, in order to modify their attention.

Locations

Country	Name	City	State
Israel	Tel-Aviv University	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis	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.	approximately 20 min
Primary	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	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.	post treatment (1 week after treatment completion) and 3-month follow up