Mindfulness and Biofeedback for Anxiety Disorders

NCT07628153 | Completed Phase 4

• 1 other identifier: 1323-2022
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders

Keywords

mindfulness; anxiety disorders; biofeedback; neurofeedback; adaptive biofeedback

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• HARS subscale scores: psychic anxiety and somatic anxiety

  Baseline, immediately after 10 day treatment, and at one month follow up.

• FFMQ subscale scores

  Baseline, immediately after 10 day treatment, and at one month follow up.

• Heart rate (HR)

  Baseline, immediately after 10 day treatment, and at one month follow up.

• EEG alpha rhythm power (alpha index)

  Baseline, immediately after 10 day treatment, and at one month follow up.

Study Arms (3)

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.

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).

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.

Combination Product: Biofeedback plus Escitalopram

Interventions

"Reacor" adaptive biofeedback system DEVICE

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.

Mindfulness Training with Adaptive Biofeedback (BFB)

Escitalopram 10 mg/day DRUG

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).

Medication Therapy (Escitalopram)

Biofeedback plus Escitalopram COMBINATION_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.

Combined Therapy (BFB + Escitalopram)

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, 119991, Russia

Location

Related Publications (3)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.).]

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Escitalopram; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Anastasia Kotelnikova, Dr. Sc. (Psychology)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start: July 11, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)