Anxiety DisordersPhase 4NCT07628153

Mindfulness and Biofeedback for Anxiety Disorders

A Phase 4 study testing "Reacor" adaptive biofeedback system, Escitalopram 10 mg/day and Biofeedback plus Escitalopram in people with Anxiety Disorders, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 74 years
Conditions the study is for: Anxiety Disorders
What is being tested?: "Reacor" adaptive biofeedback system, Escitalopram 10 mg/day and Biofeedback plus Escitalopram
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: 1 siteRussia
Study dates: 11 Jul 2022to 24 Feb 2025
Phase: Phase 4
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 19 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

First time diagnosis of anxiety disorder (ICD 10 codes F40 or F41), Inpatient at the time of enrollment, Mild to moderate functional impairment according to the International Classification of Functioning, Disability and Health (ICF), Age 19-74 years, Willing and able to provide written informed consent
Non-inclusion criteria:
Photosensitive epilepsy, Severe intellectual, attentional, or memory impairment, Exacerbation of mental illness, Lack of motivation, Unwillingness or inability to provide written consent

Who cannot join

exacerbation of a severe mental and/or somatic disease, withdrawal of consent, inability to attend one or more individual sessions, refusal to do homework, inability to complete all three assessments

Trial locations and contacts

1 site in 1 country.

Russia1 site

Department of Psychotherapy of the A.Ya. Kozhevnikov Clinic of Nervous Diseases at the Sechenov University Clinical Center
Moscow, 119991

Other trials in Russia

About this study

Official title: Development of Mindfulness Through Adaptive Biofeedback Methods in the Treatment of Anxiety Disorders: Randomized Controlled Trial

This randomized controlled trial compared the effectiveness of a 10-day mindfulness training program using adaptive biofeedback (BFB) versus medication therapy (escitalopram 10 mg/day) versus combined treatment (BFB + medication) in inpatients with anxiety disorders (ICD-10 F40/F41). The primary outcomes were changes in anxiety (Hamilton Anxiety Rating Scale, HARS) and mindfulness (Five Facet Mindfulness Questionnaire, FFMQ) from baseline to post-treatment and at one-month follow-up.

Read the detailed description

This was an open-label, randomized, parallel-group study conducted at the Department of Psychotherapy of [Blinded for Review] between July 2022 and February 2025. Adult inpatients (age 19-74 years) with a first-time diagnosis of anxiety disorder according to ICD-10 codes F40 and F41 were eligible. Exclusion criteria included photosensitive epilepsy, severe cognitive impairment, exacerbation of mental illness, lack of motivation, and inability to provide informed consent.

Participants were randomly assigned (simple unrestricted randomization) to one of three groups:

BFB group (n=76): 10 daily 60-minute individual sessions of mindfulness training using the "Reacor" adaptive biofeedback system, which records physiological parameters (heart rate, EEG alpha rhythm) and converts them into real-time auditory and visual signals.

Medication therapy (MT) group (n=46): escitalopram 10 mg once daily from day 1, continued through follow-up.

Combined therapy (CT) group (n=58): both BFB training and escitalopram 10 mg/day as above.

All patients received standard inpatient medical care. No concomitant psychotherapy, physiotherapy, or additional psychotropic medications were allowed.

Assessments were conducted at three time points: baseline (T0), immediately after the 10-day treatment (T1), and one month after treatment completion (T2). The primary outcomes were the change from baseline in the Hamilton Anxiety Rating Scale (HARS) total score (assessed by an independent blinded psychiatrist) and the Five Facet Mindfulness Questionnaire (FFMQ) total score (self-reported). Secondary outcomes included HARS subscales (somatic and psychic anxiety), FFMQ subscales (observing, describing, acting with awareness, non-judging, non-reactivity), heart rate, and EEG alpha-rhythm power.

Adherence was monitored through daily rounds and pill counts. A per-protocol analysis was conducted on 180 completers; an intention-to-treat analysis (worst-case imputation) was performed on all 188 randomized patients. Repeated-measures MANOVA and ANOVA with Scheffé post-hoc tests were used. A priori sample size calculation (GPower 3.1.9.7) based on a medium effect size (f=0.30), α=0.05, power=0.80, and correlation among repeated measures r=0.5 indicated a required total sample size of 138. Allowing for 15% dropout, we aimed to recruit at least 159 patients; the final per-protocol sample of 180 exceeded this requirement.

Conditions: Anxiety Disorders
Being tested: "Reacor" adaptive biofeedback system, Escitalopram 10 mg/day, Biofeedback plus Escitalopram
Keywords: mindfulness, anxiety disorders, biofeedback, neurofeedback, adaptive biofeedback
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"Reacor" adaptive biofeedback systemDevice
The Reacor system records physiological parameters (heart rate, EEG alpha rhythm) and converts them into real-time auditory and visual signals. Patients undergo 10 daily 60-minute sessions of adaptive biofeedback training aimed at increasing alpha-rhythm power and heart rate variability, thereby developing self-regulation and mindfulness skills. Each session includes 20 minutes of active training with feedback.
Escitalopram 10 mg/dayDrug
Escitalopram 10 mg orally once daily in the morning, started on day 1 without dose titration. Treatment continued during inpatient stay and through one-month follow-up. Adherence monitored by pill count and daily clinical rounds. Therapy follows clinical recommendations approved by the Ministry of Health of the Russian Federation (level A, certainty 1).
Biofeedback plus EscitalopramCombination product
Participants underwent 10 daily 60 minute biofeedback sessions identical to the BFB group, plus daily oral escitalopram 10 mg. The schedule, procedures, and adherence monitoring were the same as in the respective monotherapy arms.

Study groups in NCT07628153
Study group	Role	What they receive
Mindfulness Training with Adaptive Biofeedback (BFB)	Experimental	Participants received 10 daily 60 minute individual sessions of mindfulness training using the "Reacor" adaptive biofeedback system (records heart rate and EEG alpha rhythm, provides real time auditory and visual feedback). Training was conducted by a certified medical psychologist over 10 working days. Receives: Device: "Reacor" adaptive biofeedback system
Medication Therapy (Escitalopram)	Active comparator	Participants received escitalopram 10 mg once daily in the morning from day 1, continued during inpatient stay and through the one month follow up. No dose titration was performed. Therapy followed clinical recommendations (level A). Receives: Drug: Escitalopram 10 mg/day
Combined Therapy (BFB + Escitalopram)	Experimental	Participants received both the adaptive biofeedback based mindfulness training (as in BFB group) and escitalopram 10 mg/day (as in MT group) concurrently, following the same schedules. Receives: Combination Product: Biofeedback plus Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hamilton Anxiety Rating Scale (HARS) total score
HARS is a 14 item clinician rated scale assessing anxiety severity. Each item scored 0 - 4 (total range 0 - 56). Higher scores indicate more severe anxiety. The scale consists of two subscales: psychic anxiety and somatic anxiety. Assessment performed by an independent psychiatrist blinded to group allocation.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.
Change in Five Facet Mindfulness Questionnaire (FFMQ) total score
FFMQ is a 39 item self report questionnaire measuring five facets of mindfulness: observing, describing, acting with awareness, non judging of inner experience, and non reactivity. Each item scored 1 - 5 (total range 39 - 195). Higher scores indicate higher levels of mindfulness. Patients completed the questionnaire at each assessment.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.

Secondary outcomes (4)

HARS subscale scores: psychic anxiety and somatic anxiety
Psychic anxiety subscale (items 1 - 7) and somatic anxiety subscale (items 8 - 14) of the HARS. Each subscale total range 0 - 28. Assessed by blinded psychiatrist.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.
FFMQ subscale scores
Five subscales of the FFMQ: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non judging (8 items), Non reactivity (7 items). Each subscale score range depends on number of items (1 - 5 per item). Self administered.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.
Heart rate (HR)
Heart rate measured using the "Reacor" system as part of functional diagnostics.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.
EEG alpha rhythm power (alpha index)
Alpha rhythm power (8 - 13 Hz) measured in occipital leads (O1, O2) using EEG "Reacor" (Medicom-MTD). Expressed as percentage of total EEG power. Recorded during resting state with eyes closed.
Measured: Baseline, immediately after 10 day treatment, and at one month follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202224 Feb 2025

First posted4 Jun 2026
Study start11 Jul 2022
Primary completion24 Feb 2025
Study completion24 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open-label, parallel-group, randomized controlled trial with three arms: (1) adaptive biofeedback-based mindfulness training (BFB), (2) escitalopram 10 mg/day (MT), (3) combined BFB + escitalopram (CT). Assessments at baseline, after 10-day treatment, and at 1-month follow-up. Primary outcomes: change in HARS (anxiety) and FFMQ (mindfulness). Assessor of HARS blinded; participants and care providers not blinded.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07628153
Sponsor's protocol ID: 1323-2022
Status last verified: May 2026
First submitted: 1 Jun 2026
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to institutional policy and the terms of informed consent, individual participant data will not be made publicly available. Only anonymized data may be shared upon reasonable request to the corresponding author.

Publications

Kostenko E.V., Kotelnikova A.V., Petrova L.V., Pogonchenkova I.V., Filippov M.S. The psychophysiological technology with biofeedback in complex rehabilitation of post-stroke patients: a randomized controlled study // Bulletin of Rehabilitation Medicine. - 2025. - Vol. 24. - N. 1. - P. 55-66. doi: 10.38025/2078-1962-2025-24-1-55-66
Ruzinova, V.M., Kotelnikova, A.V., Kiseleva, M.G. (2026). Biofeedback as a Tool for Psychological Self-Regulation: Mechanisms, Effectiveness, and Clinical and Psychological Application. New Psychological Research, No. 1, 203-218. DOI: 10.51217/npsyresearch_2026_06_01_11
Kostenko E.V., Kotelnikova A.V., Pogonchenkova I.V., Petrova L.V., Khaustova A.V., Filippov M.S., Kaverina E.V. Psychophysiological Technologies Using the Biofeedback Method: an Analytical Review. Bulletin of Rehabilitation Medicine. 2024; 23(3):77-91. https://doi.org/10.38025/2078-1962-2024-23-3-77-91 (In Russ.).]
Kotelnikova AV, Ruzinova VM, Kiseleva MG, Volel B, Kukshina AA. Mindfulness Development via Biofeedback for Anxiety in Hospitalized Patients: A Randomized Controlled Trial. Brain Sci. 2026 Jul 15;16(7):748. doi: 10.3390/brainsci16070748.
PubMed 42512522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Mindfulness Through Adaptive Biofeedback Methods in the Treatment of Anxiety Disorders: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07628153
Acronym / sponsor ID: 1323-2022
Conditions: Anxiety Disorders
Keywords: mindfulness, anxiety disorders, biofeedback, neurofeedback, adaptive biofeedback
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
Study start: 11 Jul 2022 (actual)
Primary completion: 24 Feb 2025 (actual)
Study completion: 24 Feb 2025 (actual)
First posted: 4 Jun 2026 (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.

Detailed description

Participants were randomly assigned (simple unrestricted randomization) to one of three groups:

Medication therapy (MT) group (n=46): escitalopram 10 mg once daily from day 1, continued through follow-up.

Combined therapy (CT) group (n=58): both BFB training and escitalopram 10 mg/day as above.

All patients received standard inpatient medical care. No concomitant psychotherapy, physiotherapy, or additional psychotropic medications were allowed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Open-label, parallel-group, randomized controlled trial with three arms: (1) adaptive biofeedback-based mindfulness training (BFB), (2) escitalopram 10 mg/day (MT), (3) combined BFB + escitalopram (CT). Assessments at baseline, after 10-day treatment, and at 1-month follow-up. Primary outcomes: change in HARS (anxiety) and FFMQ (mindfulness). Assessor of HARS blinded; participants and care providers not blinded.

Arm	Type	Receives
Mindfulness Training with Adaptive Biofeedback (BFB)	Experimental	Device: "Reacor" adaptive biofeedback systemParticipants received 10 daily 60 minute individual sessions of mindfulness training using the "Reacor" adaptive biofeedback system (records heart rate and EEG alpha rhythm, provides real time auditory and visual feedback). Training was conducted by a certified medical psychologist over 10 working days.
Medication Therapy (Escitalopram)	Active comparator	Drug: Escitalopram 10 mg/dayParticipants received escitalopram 10 mg once daily in the morning from day 1, continued during inpatient stay and through the one month follow up. No dose titration was performed. Therapy followed clinical recommendations (level A).
Combined Therapy (BFB + Escitalopram)	Experimental	Combination Product: Biofeedback plus EscitalopramParticipants received both the adaptive biofeedback based mindfulness training (as in BFB group) and escitalopram 10 mg/day (as in MT group) concurrently, following the same schedules.

Who may qualify

Ages: 19 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

First time diagnosis of anxiety disorder (ICD 10 codes F40 or F41), Inpatient at the time of enrollment, Mild to moderate functional impairment according to the International Classification of Functioning, Disability and Health (ICF), Age 19-74 years, Willing and able to provide written informed consent
Photosensitive epilepsy, Severe intellectual, attentional, or memory impairment, Exacerbation of mental illness, Lack of motivation, Unwillingness or inability to provide written consent

Key exclusion criteria (1 listed)

exacerbation of a severe mental and/or somatic disease, withdrawal of consent, inability to attend one or more individual sessions, refusal to do homework, inability to complete all three assessments

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
"Reacor" adaptive biofeedback systemThe Reacor system records physiological parameters (heart rate, EEG alpha rhythm) and converts them into real-time auditory and visual signals. Patients undergo 10 daily 60-minute sessions of adaptive biofeedback training aimed at increasing alpha-rhythm power and heart rate variability, thereby developing self-regulation and mindfulness skills. Each session includes 20 minutes of active training with feedback.	Device	Mindfulness Training with Adaptive Biofeedback (BFB)
Escitalopram 10 mg/dayEscitalopram 10 mg orally once daily in the morning, started on day 1 without dose titration. Treatment continued during inpatient stay and through one-month follow-up. Adherence monitored by pill count and daily clinical rounds. Therapy follows clinical recommendations approved by the Ministry of Health of the Russian Federation (level A, certainty 1).	Drug	Medication Therapy (Escitalopram)
Biofeedback plus EscitalopramParticipants underwent 10 daily 60 minute biofeedback sessions identical to the BFB group, plus daily oral escitalopram 10 mg. The schedule, procedures, and adherence monitoring were the same as in the respective monotherapy arms.	Combination product	Combined Therapy (BFB + Escitalopram)

Primary outcome

Change in Hamilton Anxiety Rating Scale (HARS) total score
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.
HARS is a 14 item clinician rated scale assessing anxiety severity. Each item scored 0 - 4 (total range 0 - 56). Higher scores indicate more severe anxiety. The scale consists of two subscales: psychic anxiety and somatic anxiety. Assessment performed by an independent psychiatrist blinded to group allocation.
Change in Five Facet Mindfulness Questionnaire (FFMQ) total score
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.
FFMQ is a 39 item self report questionnaire measuring five facets of mindfulness: observing, describing, acting with awareness, non judging of inner experience, and non reactivity. Each item scored 1 - 5 (total range 39 - 195). Higher scores indicate higher levels of mindfulness. Patients completed the questionnaire at each assessment.

4 secondary outcomes

HARS subscale scores: psychic anxiety and somatic anxiety
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.
FFMQ subscale scores
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.
Heart rate (HR)
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.
EEG alpha rhythm power (alpha index)
Time frame: Baseline, immediately after 10 day treatment, and at one month follow up.

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 4 Jun 2026.
BackgroundKostenko E.V., Kotelnikova A.V., Petrova L.V., Pogonchenkova I.V., Filippov M.S. The psychophysiological technology with biofeedback in complex rehabilitation of post-stroke patients: a randomized controlled study // Bulletin of Rehabilitation Medicine. - 2025. - Vol. 24. - N. 1. - P. 55-66. doi: 10.38025/2078-1962-2025-24-1-55-66
BackgroundRuzinova, V.M., Kotelnikova, A.V., Kiseleva, M.G. (2026). Biofeedback as a Tool for Psychological Self-Regulation: Mechanisms, Effectiveness, and Clinical and Psychological Application. New Psychological Research, No. 1, 203-218. DOI: 10.51217/npsyresearch_2026_06_01_11
BackgroundKostenko E.V., Kotelnikova A.V., Pogonchenkova I.V., Petrova L.V., Khaustova A.V., Filippov M.S., Kaverina E.V. Psychophysiological Technologies Using the Biofeedback Method: an Analytical Review. Bulletin of Rehabilitation Medicine. 2024; 23(3):77-91. https://doi.org/10.38025/2078-1962-2024-23-3-77-91 (In Russ.).]
Derived from this study: PubMed 42512522Kotelnikova AV, Ruzinova VM, Kiseleva MG, Volel B, Kukshina AA. Mindfulness Development via Biofeedback for Anxiety in Hospitalized Patients: A Randomized Controlled Trial. Brain Sci. 2026 Jul 15;16(7):748. doi: 10.3390/brainsci16070748.
Individual participant dataSharing planned: No. Due to institutional policy and the terms of informed consent, individual participant data will not be made publicly available. Only anonymized data may be shared upon reasonable request to the corresponding author.

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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.

Anastasia Kotelnikova, Dr. Sc. (Psychology) principal investigator

I.M. Sechenov First Moscow State Medical University (Sechenov University)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 1 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 4 Jun 2026. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hamilton Anxiety Rating Scale (HARS) total score (time frame: Baseline, immediately after 10 day treatment, and at one month follow up.). 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?

On the ClinicalTrials.gov record for NCT07628153, which also lists 4 linked publications.

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 4 Jun 2026.