NCT05025904

Real-time fMRI Neurofeedback for Mild/Moderate Depression

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Federal Research Center of Fundamental and Translational Medicine, Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	Сognitive behavioral therapy (CBT)	A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
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.

Timeline

• Start date: 2017-06-06
• Primary completion: 2019-04-09
• Completion: 2019-04-09
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

1 site across 1 country: Russia