Real-time fMRI Neurofeedback for Mild/Moderate Depression

NCT ID: NCT05025904

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2019-04-09

Brief Summary

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.

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.

Conditions

Depression Mild; Depression Moderate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Real-time fMRI neurofeedback (rt-fMRI NFB)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Сognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.

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.

Group Type: ACTIVE_COMPARATOR

EEG neurofeedback (EEG NFB)

Intervention Type: BEHAVIORAL

EEG neurofeedback targeting frontal alpha asymmetry index. Participants continuously received visual feedback on their frontal alpha asymmetry index. Up-regulation condition only was utilized.

Interventions

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.

Intervention Type: BEHAVIORAL

Сognitive behavioral therapy (CBT)

A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Research Center of Fundamental and Translational Medicine, Russian Federation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark B. Shtark, Ph.D.

Role: STUDY_DIRECTOR

FRC FTM

Locations

Federal Reserch Center of Fundamental and Translational Medicine

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

16-15-00183

Identifier Type: -

Identifier Source: org_study_id