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Completed

NCT Number: NCT05025904

Real-time fMRI Neurofeedback for Mild/Moderate Depression

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.

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Key information

Conditions

Depression Mild Depression Moderate

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Reserch Center of Fundamental and Translational Medicine

Novosibirsk, 630117, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Сognitive behavioral therapy (CBT)

Behavioral

A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.

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.

Primary outcomes

  1. Change in depression symptoms severity from baseline to end-treatment

    Time frame: 4.5 months on average

    Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression

  2. Change in depression symptoms severity from baseline to mid-treatment

    Time frame: 2.5 months on average

    Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression

Secondary outcomes

  1. Change in subjective depression severity, test 1 from baseline to end-treatment

    Time frame: 4.5 months on average

    Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression

  2. Change in subjective depression severity, test 1 from baseline to mid-treatment

    Time frame: 2.5 months on average

    Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression

  3. Change in subjective depression severity, test 2 from baseline to end-treatment

    Time frame: 4.5 months on average

    Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression

  4. Change in subjective depression severity, test 2 from baseline to mid-treatment

    Time frame: 2.5 months on average

    Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression

  5. Change in the raw estimate of subjective depression severity from baseline to end-treatment

    Time frame: 4.5 months on average

    Hospital Anxiety and Depression Scale (HADS), depression subscale, scores ranging 0-21, higher scores indicate more severe subjective depression

  6. Change in the raw estimate of subjective depression severity from baseline to mid-treatment

    Time frame: 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 outcomes

  1. Change in adult anxious attachment from baseline to end-treatment

    Time frame: 4.5 months on average

    Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption

  2. Change in adult anxious attachment from baseline to mid-treatment

    Time frame: 2.5 months on average

    Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption

  3. Change in adult avoidant attachment from baseline to end-treatment

    Time frame: 4.5 months on average

    Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption

  4. Change in adult avoidant attachment from baseline to mid-treatment

    Time frame: 2.5 months on average

    Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption

  5. Change in rumination level from baseline to end-treatment

    Time frame: 4.5 months on average

    Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination

  6. Change in rumination level from baseline to mid-treatment

    Time frame: 2.5 months on average

    Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination

  7. Change in alexithymia level from baseline to end-treatment

    Time frame: 4.5 months on average

    Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia

  8. Change in alexithymia level from baseline to mid-treatment

    Time frame: 2.5 months on average

    Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia

Sponsors and collaborators

Lead sponsor

Federal Research Center of Fundamental and Translational Medicine, Russian Federation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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