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Mindfulness and Biofeedback for Anxiety Disorders
Sponsor: I.M. Sechenov First Moscow State Medical University
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.
Official title: Development of Mindfulness Through Adaptive Biofeedback Methods in the Treatment of Anxiety Disorders: Randomized Controlled Trial
Key Details
Gender
All
Age Range
19 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2022-07-11
Completion Date
2025-02-24
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
"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.
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).
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.
Locations (1)
Department of Psychotherapy of the A.Ya. Kozhevnikov Clinic of Nervous Diseases at the Sechenov University Clinical Center
Moscow, Russia