Clinical trial NCT05025904: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Depression Moderate
Keywords: Neurofeedback
Functional Magnetic Resonance Imaging
Cognitive Behavioral Therapy
Lead sponsor: Federal Research Center of Fundamental and Translational Medicine, Russian Federation
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depression symptoms severity from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in depression symptoms severity from baseline to mid-treatment
timeFrame: 2.5 months on average
Secondary outcomes:
measure: Change in subjective depression severity, test 1 from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in subjective depression severity, test 1 from baseline to mid-treatment
timeFrame: 2.5 months on average
measure: Change in subjective depression severity, test 2 from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in subjective depression severity, test 2 from baseline to mid-treatment
timeFrame: 2.5 months on average
measure: Change in the raw estimate of subjective depression severity from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in the raw estimate of subjective depression severity from baseline to mid-treatment
timeFrame: 2.5 months on average
Other outcomes:
measure: Change in adult anxious attachment from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in adult anxious attachment from baseline to mid-treatment
timeFrame: 2.5 months on average
measure: Change in adult avoidant attachment from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in adult avoidant attachment from baseline to mid-treatment
timeFrame: 2.5 months on average
measure: Change in rumination level from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in rumination level from baseline to mid-treatment
timeFrame: 2.5 months on average
measure: Change in alexithymia level from baseline to end-treatment
timeFrame: 4.5 months on average
measure: Change in alexithymia level from baseline to mid-treatment
timeFrame: 2.5 months on average
Locations:
city: Novosibirsk
country: Russian Federation
facility: Federal Reserch Center of Fundamental and Translational Medicine
Study officials:
affiliation: FRC FTM
name: Mark B. Shtark, Ph.D.
role: STUDY_DIRECTOR
References: