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Real-time fMRI Neurofeedback for Mild/Moderate Depression

Primary Purpose

Depression Mild, Depression Moderate

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Real-time fMRI neurofeedback (rt-fMRI NFB)
Сognitive behavioral therapy (CBT)
EEG neurofeedback (EEG NFB)
Sponsored by
Federal Research Center of Fundamental and Translational Medicine, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Mild focused on measuring Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Reserch Center of Fundamental and Translational Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Real-time fMRI neurofeedback (rt-fMRI NFB)

Сognitive behavioral therapy (CBT)

EEG neurofeedback (EEG NFB)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
August 18, 2021
Last Updated
August 24, 2021
Sponsor
Federal Research Center of Fundamental and Translational Medicine, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT05025904
Brief Title
Real-time fMRI Neurofeedback for Mild/Moderate Depression
Official Title
The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Center of Fundamental and Translational Medicine, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depression Moderate
Keywords
Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time fMRI neurofeedback (rt-fMRI NFB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Сognitive behavioral therapy (CBT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EEG neurofeedback (EEG NFB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Real-time fMRI neurofeedback (rt-fMRI NFB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Сognitive behavioral therapy (CBT)
Intervention Description
A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
Intervention Type
Behavioral
Intervention Name(s)
EEG neurofeedback (EEG NFB)
Intervention Description
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 Outcome Measure Information:
Title
Change in depression symptoms severity from baseline to end-treatment
Description
Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression
Time Frame
4.5 months on average
Title
Change in depression symptoms severity from baseline to mid-treatment
Description
Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression
Time Frame
2.5 months on average
Secondary Outcome Measure Information:
Title
Change in subjective depression severity, test 1 from baseline to end-treatment
Description
Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression
Time Frame
4.5 months on average
Title
Change in subjective depression severity, test 1 from baseline to mid-treatment
Description
Beck Depression Inventory (BDI), scores ranging 0-63, higher scores indicate more severe subjective depression
Time Frame
2.5 months on average
Title
Change in subjective depression severity, test 2 from baseline to end-treatment
Description
Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression
Time Frame
4.5 months on average
Title
Change in subjective depression severity, test 2 from baseline to mid-treatment
Description
Zung Self-Rating Depression Scale (ZSRDS), scores ranging 20-80, higher scores indicate more severe subjective depression
Time Frame
2.5 months on average
Title
Change in the raw estimate of subjective depression severity from baseline to end-treatment
Description
Hospital Anxiety and Depression Scale (HADS), depression subscale, scores ranging 0-21, higher scores indicate more severe subjective depression
Time Frame
4.5 months on average
Title
Change in the raw estimate of subjective depression severity from baseline to mid-treatment
Description
Hospital Anxiety and Depression Scale (HADS), depression subscale, scores ranging 0-21, higher scores indicate more severe subjective depression
Time Frame
2.5 months on average
Other Pre-specified Outcome Measures:
Title
Change in adult anxious attachment from baseline to end-treatment
Description
Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption
Time Frame
4.5 months on average
Title
Change in adult anxious attachment from baseline to mid-treatment
Description
Experience in Close Relationships (ECR), anxious attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption
Time Frame
2.5 months on average
Title
Change in adult avoidant attachment from baseline to end-treatment
Description
Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption
Time Frame
4.5 months on average
Title
Change in adult avoidant attachment from baseline to mid-treatment
Description
Experience in Close Relationships (ECR), avoidant attachment subscale, scores ranging 15-105, higher scores indicate more attachment disruption
Time Frame
2.5 months on average
Title
Change in rumination level from baseline to end-treatment
Description
Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination
Time Frame
4.5 months on average
Title
Change in rumination level from baseline to mid-treatment
Description
Rumination Response Scale (RRS), total rumination score, scores ranging 22-88, higher scores indicate more rumination
Time Frame
2.5 months on average
Title
Change in alexithymia level from baseline to end-treatment
Description
Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia
Time Frame
4.5 months on average
Title
Change in alexithymia level from baseline to mid-treatment
Description
Toronto Alexithymia Scale (TAS-26), scores ranging 26-130, higher scores indicate more alexithymia
Time Frame
2.5 months on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark B. Shtark, Ph.D.
Organizational Affiliation
FRC FTM
Official's Role
Study Director
Facility Information:
Facility Name
Federal Reserch Center of Fundamental and Translational Medicine
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation

12. IPD Sharing Statement

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Real-time fMRI Neurofeedback for Mild/Moderate Depression

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