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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adult anxious attachment from baseline to end-treatment | Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption | 4.5 months on average |
| Change in adult anxious attachment from baseline to mid-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark B. Shtark, Ph.D. | FRC FTM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Reserch Center of Fundamental and Translational Medicine | Novosibirsk | 630117 | Russia |
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Participants were assigned to one of 3 groups: real-time fMRI neurofeedback (rt-fMRI NFB), EEG neurofeedback (aborted), and cognitive behavioral therapy (CBT).
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| Сognitive behavioral therapy (CBT) | Behavioral | A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist. |
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| 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. |
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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 |
Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption |
| 2.5 months on average |
| Change in adult avoidant attachment from baseline to end-treatment | Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption | 4.5 months on average |
| Change in adult avoidant attachment from baseline to mid-treatment | Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption | 2.5 months on average |
| Change in rumination level from baseline to end-treatment | Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination | 4.5 months on average |
| Change in rumination level from baseline to mid-treatment | Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination | 2.5 months on average |
| Change in alexithymia level from baseline to end-treatment | Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia | 4.5 months on average |
| Change in alexithymia level from baseline to mid-treatment | Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia | 2.5 months on average |