Depression Mild, Depression Moderate
Conditions
Keywords
Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALReal-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.
BEHAVIORALСognitive behavioral therapy (CBT)
A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
BEHAVIORALEEG 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.
Sponsors
Federal Research Center of Fundamental and Translational Medicine, Russian Federation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in adult anxious attachment from baseline to end-treatment | 4.5 months on average | Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption |
| Change in adult anxious attachment from baseline to mid-treatment | 2.5 months on average | Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption |
| Change in adult avoidant attachment from baseline to end-treatment | 4.5 months on average | Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption |
| Change in adult avoidant attachment from baseline to mid-treatment | 2.5 months on average | Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption |
| Change in rumination level from baseline to end-treatment | 4.5 months on average | Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination |
| Change in rumination level from baseline to mid-treatment | 2.5 months on average | Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination |
| Change in alexithymia level from baseline to end-treatment | 4.5 months on average | Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia |
| Change in alexithymia level from baseline to mid-treatment | 2.5 months on average | Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia |
Countries
Russia
Outcome results
None listed