Real-time fMRI Neurofeedback for Mild/Moderate Depression

Depression Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025904
• Other study ID #: 16-15-00183
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: August 2021
• Source: Federal Research Center of Fundamental and Translational Medicine, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depressive Disorder

Intervention

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.
• ?ognitive behavioral therapy (CBT)
A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
• 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.

Locations

Country	Name	City	State
Russian Federation	Federal Reserch Center of Fundamental and Translational Medicine	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Center of Fundamental and Translational Medicine, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

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