Real-time fMRI Neurofeedback for Mild/Moderate Depression

Not Applicable

Completed

• Conditions: Depression Moderate; Depression Mild
• Interventions: Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB); Behavioral: EEG neurofeedback (EEG NFB); Behavioral: Сognitive behavioral therapy (CBT)

• Registration Number: NCT05025904
• Lead Sponsor: Federal Research Center of Fundamental and Translational Medicine, Russian Federation

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.

Study Timeline

• Study Start: 2017-06-06
• Primary Completion: 2019-04-09
• Study Completion: 2019-04-09
• Status Verified: 2021-08
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time fMRI neurofeedback (rt-fMRI NFB)	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.
EEG neurofeedback (EEG NFB)	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.
Сognitive behavioral therapy (CBT)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Federal Reserch Center of Fundamental and Translational Medicine; 🇷🇺 Novosibirsk, Russian Federation