Depression MildNCT05025904
Real-time fMRI Neurofeedback for Mild/Moderate Depression
A study testing Real-time fMRI neurofeedback (rt-fMRI NFB), Сognitive behavioral therapy (CBT) and EEG neurofeedback (EEG NFB) in people with Depression Mild and Depression Moderate, run by Federal Research Center of Fundamental and Translational Medicine, Russian Federation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- Real-time fMRI neurofeedback (rt-fMRI NFB), Сognitive behavioral therapy (CBT) and EEG neurofeedback (EEG NFB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteRussia
- Study dates
- 6 Jun 2017to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- Receiving cardiovascular medications
- General MRI exclusions
- Current pregnancy
- IQ<70 (established with Raven's progressive matrices)
- Previous experience with neurofeedback
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Reserch Center of Fundamental and Translational Medicine
Novosibirsk, 630117
About this study
Official title: The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive 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.
Read the 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.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- Real-time fMRI neurofeedback (rt-fMRI NFB), Сognitive behavioral therapy (CBT), EEG neurofeedback (EEG NFB)
- Keywords
- Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI neurofeedback (rt-fMRI NFB)Behavioural
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)Behavioural
A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
EEG neurofeedback (EEG NFB)Behavioural
EEG neurofeedback targeting frontal alpha asymmetry index. Participants continuously received visual feedback on their frontal alpha asymmetry index. Up-regulation condition only was utilized.
| Study group | Role | What they receive |
|---|---|---|
| Real-time fMRI neurofeedback (rt-fMRI NFB) | Experimental | 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. Receives: Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB) |
| Сognitive behavioral therapy (CBT) | Active comparator | 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. Receives: Behavioral: Сognitive behavioral therapy (CBT) |
| EEG neurofeedback (EEG NFB) | Active comparator | 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. Receives: Behavioral: EEG neurofeedback (EEG NFB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4.5 months on average
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
Measured: 2.5 months on average
Secondary outcomes (6)
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
Measured: 4.5 months on average
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
Measured: 2.5 months on average
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
Measured: 4.5 months on average
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
Measured: 2.5 months on average
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
Measured: 4.5 months on average
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
Measured: 2.5 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start6 Jun 2017
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Center of Fundamental and Translational Medicine, Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark B. Shtark, Ph.D., Study director, FRC FTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025904
- Sponsor's protocol ID
- 16-15-00183
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive Depression
- ClinicalTrials.gov ID
- NCT05025904
- Acronym / sponsor ID
- 16-15-00183
- Conditions
- Depression Mild, Depression Moderate
- Keywords
- Neurofeedback, Functional Magnetic Resonance Imaging, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federal Research Center of Fundamental and Translational Medicine, Russian FederationUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Real-time fMRI neurofeedback (rt-fMRI NFB) | Experimental | Behavioral: Real-time fMRI neurofeedback (rt-fMRI NFB)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. |
| Сognitive behavioral therapy (CBT) | Active comparator | Behavioral: Сognitive behavioral therapy (CBT)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. |
| EEG neurofeedback (EEG NFB) | Active comparator | Behavioral: EEG neurofeedback (EEG NFB)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Real-time fMRI neurofeedback (rt-fMRI NFB) |
| Сognitive behavioral therapy (CBT)A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist. | Behavioural | Сognitive behavioral therapy (CBT) |
| 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. | Behavioural | EEG neurofeedback (EEG NFB) |
Primary outcome
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
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
6 secondary outcomes
Change in subjective depression severity, test 1 from baseline to end-treatment
Time frame: 4.5 months on average
Change in subjective depression severity, test 1 from baseline to mid-treatment
Time frame: 2.5 months on average
Change in subjective depression severity, test 2 from baseline to end-treatment
Time frame: 4.5 months on average
Change in subjective depression severity, test 2 from baseline to mid-treatment
Time frame: 2.5 months on average
Change in the raw estimate of subjective depression severity from baseline to end-treatment
Time frame: 4.5 months on average
Change in the raw estimate of subjective depression severity from baseline to mid-treatment
Time frame: 2.5 months on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark B. Shtark, Ph.D. study director
FRC FTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time fMRI neurofeedback (rt-fMRI NFB), Сognitive behavioral therapy (CBT) and EEG neurofeedback (EEG NFB) in people with Depression Mild and Depression Moderate, run by Federal Research Center of Fundamental and Translational Medicine, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms severity from baseline to end-treatment (time frame: 4.5 months on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.