Depression Mild Clinical Trial
Official title:
The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive Depression
NCT number | NCT05025904 |
Other study ID # | 16-15-00183 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2017 |
Est. completion date | April 9, 2019 |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | April 9, 2019 |
Est. primary completion date | April 9, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal Reserch Center of Fundamental and Translational Medicine | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Federal Research Center of Fundamental and Translational Medicine, Russian Federation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Change in adult anxious attachment from baseline to mid-treatment | Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption | 2.5 months on average | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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