Real-time fMRI Neurofeedback for Mild/Moderate Depression

NCT05025904 | Completed

• 1 other identifier: 16-15-00183
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Mild; Depression Moderate

Keywords

Neurofeedback; Functional Magnetic Resonance Imaging; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in subjective depression severity, test 1 from baseline to end-treatment

  4.5 months on average

• Change in subjective depression severity, test 1 from baseline to mid-treatment

  2.5 months on average

• Change in subjective depression severity, test 2 from baseline to end-treatment

  4.5 months on average

• Change in subjective depression severity, test 2 from baseline to mid-treatment

  2.5 months on average

• Change in the raw estimate of subjective depression severity from baseline to end-treatment

  4.5 months on average

Other Outcomes (8)

• Change in adult anxious attachment from baseline to end-treatment

  4.5 months on average

• Change in adult anxious attachment from baseline to mid-treatment

  2.5 months on average

• Change in adult avoidant attachment from baseline to end-treatment

  4.5 months on average

Study Arms (3)

Real-time fMRI neurofeedback (rt-fMRI NFB)

EXPERIMENTAL

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)

Сognitive behavioral therapy (CBT)

ACTIVE COMPARATOR

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)

EEG neurofeedback (EEG NFB)

ACTIVE COMPARATOR

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)

Interventions

Real-time fMRI neurofeedback (rt-fMRI NFB) 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.

Real-time fMRI neurofeedback (rt-fMRI NFB)

Сognitive behavioral therapy (CBT) BEHAVIORAL

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

Сognitive behavioral therapy (CBT)

EEG neurofeedback (EEG NFB) 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.

EEG neurofeedback (EEG NFB)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Current pregnancy
• IQ\<70 (established with Raven's progressive matrices)
• Previous experience with neurofeedback

Sponsors & Collaborators

• Federal Research Center of Fundamental and Translational Medicine, Russian Federation: lead

Study Sites (1)

Federal Reserch Center of Fundamental and Translational Medicine

Novosibirsk, 630117, Russia

Location

Study Officials

• Mark B. Shtark, Ph.D.

  FRC FTM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned to one of 3 groups: real-time fMRI neurofeedback (rt-fMRI NFB), EEG neurofeedback (aborted), and cognitive behavioral therapy (CBT).

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 27, 2021
• Study Start: June 6, 2017
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

RU (1)