Real-time fMRI Neurofeedback for Mild/Moderate Depression

The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive Depression

The aim of the study is to compare the effects of the self-regulation (neurofeedback) of the fMRI signal of the prefrontal cortex in depression to ones of more conventional non-pharmacological treatment, primarily, psychotherapy.

Study Overview

• Status: Completed
• Conditions: Depression Moderate; Depression Mild
• Intervention / Treatment: Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB); Behavioral: Сognitive behavioral therapy (CBT); Behavioral: EEG neurofeedback (EEG NFB)

Detailed Description

The study was devoted to the neural, clinical, and psychological effects of the rt-fMRI neurofeedback for mild/moderate depression. Recruited unmedicated patients suffering from depression were assigned either to the fMRI neurofeedback (8 sessions of the left prefrontal cortex activity regulation) or to the active control group, i.e., a double dosage of cognitive-behavioral treatment or EEG neurofeedback (preliminary aborted). Depression symptoms were measured at baseline, at mid-treatment, and at post-treatment points. Some inventories of depression and related traits were also given. In the rt-fMRI group, self-regulation learning was also estimated by means of the fMRI signal change.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630117
    • Federal Reserch Center of Fundamental and Translational Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A diagnosis of unipolar depressive disorder on ICD-10 (F32, F33, F34.1)
• Sufficient self-regulation ability (verified with 3 sessions of ALAY EEG neurofeedback)

Exclusion Criteria:

• Serious somatic, mental, or substance abuse problem other than depression
• Depression secondary to other mental or somatic conditions
• Psychotic features in depression or comorbid psychotic disorder
• Serious suicide risk
• Seasonal depression
• Receiving or planning to receive psychotropic medications
• Receiving cardiovascular medications
• General MRI exclusions
• Current pregnancy
• IQ<70 (established with Raven's progressive matrices)
• Previous experience with neurofeedback

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real-time fMRI neurofeedback (rt-fMRI NFB); The duration of a session was approximately a half-hour. The course duration was 8 sessions. The preferred frequency was once a week, however, the schedule was flexibly adjusted for patients' convenience.	Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB); Real-time fMRI neurofeedback targeting control of the left medial prefrontal cortex. Participants continuously received visual feedback on the level of activity within the 2D region of interest corrected to the whole-slice brain volume activity. Up- and downregulation blocks were switched for better control.
Active Comparator: Сognitive behavioral therapy (CBT); The duration of a session was approximately an hour/hour and a half. The course duration was 8 individual and 8 group sessions and included home assignments. The preferred frequency was twice a week, however, the schedule was flexibly adjusted for patients' convenience and for improving benefits of the treatment.	Behavioral: Сognitive behavioral therapy (CBT); A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
Active Comparator: EEG neurofeedback (EEG NFB); The duration of a session was approximately a half-hour. The course duration was 16 sessions. The preferred frequency was twice a week, however, the schedule was flexibly adjusted for patients' convenience. Group was preliminarily aborted for lack of time and participants in order to assign more patients to the abovementioned arms.	Behavioral: EEG neurofeedback (EEG NFB); EEG neurofeedback targeting frontal alpha asymmetry index. Participants continuously received visual feedback on their frontal alpha asymmetry index. Up-regulation condition only was utilized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression symptoms severity from baseline to end-treatment	Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression	4.5 months on average
Change in depression symptoms severity from baseline to mid-treatment	Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression	2.5 months on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective depression severity, test 1 from baseline to end-treatment	Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression	4.5 months on average
Change in subjective depression severity, test 1 from baseline to mid-treatment	Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression	2.5 months on average
Change in subjective depression severity, test 2 from baseline to end-treatment	Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression	4.5 months on average
Change in subjective depression severity, test 2 from baseline to mid-treatment	Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression	2.5 months on average
Change in the raw estimate of subjective depression severity from baseline to end-treatment	Hospital Anxiety and Depression Scale (HADS), depression subscale, scores ranging 0-21, higher scores indicate more severe subjective depression	4.5 months on average
Change in the raw estimate of subjective depression severity from baseline to mid-treatment	Hospital Anxiety and Depression Scale (HADS), depression subscale, scores ranging 0-21, higher scores indicate more severe subjective depression	2.5 months on average

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adult anxious attachment from baseline to end-treatment	Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption	4.5 months on average
Change in adult anxious attachment from baseline to mid-treatment	Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption	2.5 months on average
Change in adult avoidant attachment from baseline to end-treatment	Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption	4.5 months on average
Change in adult avoidant attachment from baseline to mid-treatment	Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption	2.5 months on average
Change in rumination level from baseline to end-treatment	Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination	4.5 months on average
Change in rumination level from baseline to mid-treatment	Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination	2.5 months on average
Change in alexithymia level from baseline to end-treatment	Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia	4.5 months on average
Change in alexithymia level from baseline to mid-treatment	Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia	2.5 months on average

Collaborators and Investigators

• Sponsor: Federal Research Center of Fundamental and Translational Medicine, Russian Federation
• Investigators: Study Director: Mark B. Shtark, Ph.D., FRC FTM

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): April 9, 2019

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging; Cognitive Behavioral Therapy; Neurofeedback
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 16-15-00183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No