Real-time fMRI Neurofeedback for Mild/Moderate Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression Mild, Depression Moderate

Intervention / Treatment
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* Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB)
* Behavioral: Сognitive behavioral therapy (CBT)
* Behavioral: EEG neurofeedback (EEG NFB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were assigned to one of 3 groups: real-time fMRI neurofeedback (rt-fMRI NFB), EEG neurofeedback (aborted), and cognitive behavioral therapy (CBT).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time fMRI neurofeedback (rt-fMRI NFB)<br>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)<br>* 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.<br>|
| Active Comparator: Сognitive behavioral therapy (CBT)<br>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)<br>* A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.<br>|
| Active Comparator: EEG neurofeedback (EEG NFB)<br>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)<br>* EEG neurofeedback targeting frontal alpha asymmetry index. Participants continuously received visual feedback on their frontal alpha asymmetry index. Up-regulation condition only was utilized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy