Mindfulness and Biofeedback for Anxiety Disorders

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Device: "Reacor" adaptive biofeedback system; Drug: Escitalopram 10 mg/day; Combination product: Biofeedback plus Escitalopram

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Training with Adaptive Biofeedback (BFB); 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.	Device: "Reacor" adaptive biofeedback system; 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.
Active Comparator: Medication Therapy (Escitalopram); 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).	Drug: Escitalopram 10 mg/day; 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).
Experimental: Combined Therapy (BFB + Escitalopram); 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.	Combination product: Biofeedback plus Escitalopram; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, immediately after 10 day treatment, and at one month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, immediately after 10 day treatment, and at one month follow up.

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Anastasia Kotelnikova, Dr. Sc. (Psychology), I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General 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.).]

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: neurofeedback; biofeedback; mindfulness; anxiety disorders; adaptive biofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Mind-Body Therapies; Complementary Therapies; Amines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nitriles; Feedback, Psychological; Propylamines; Benzofurans; Escitalopram; Biofeedback, Psychology
• Other Study ID Numbers: 1323-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No