Real-time fMRI Neurofeedback for Mild/Moderate Depression

Federal Research Center of Fundamental and Translational Medicine, Russian Federation

Status: Completed

Conditions: Depression Mild; Depression Moderate

Treatments: Behavioral: Сognitive behavioral therapy (CBT); Behavioral: EEG neurofeedback (EEG NFB); Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05025904

16-15-00183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Real-time fMRI neurofeedback (rt-fMRI NFB)

Experimental group

Description:

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.

Treatment:

Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB)

Сognitive behavioral therapy (CBT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Сognitive behavioral therapy (CBT)

EEG neurofeedback (EEG NFB)

Active Comparator group

Description:

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.

Treatment:

Behavioral: EEG neurofeedback (EEG NFB)