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Mindfulness and Biofeedback for Anxiety Disorders

NCT07628153 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-06-04

No results posted yet for this study

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

Interventions

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.

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).

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.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Anastasia Kotelnikova, Dr. Sc. (Psychology) · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2025-02-24
Completion
2025-02-24

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628153 on ClinicalTrials.gov