Mindfulness and Biofeedback for Anxiety Disorders
Development of Mindfulness Through Adaptive Biofeedback Methods in the Treatment of Anxiety Disorders: Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Moscow, 러시아 제국, 119991
- Department of Psychotherapy of the A.Ya. Kozhevnikov Clinic of Nervous Diseases at the Sechenov University Clinical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: 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).
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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).
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hamilton Anxiety Rating Scale (HARS) total score
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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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.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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Change in Five Facet Mindfulness Questionnaire (FFMQ) total score
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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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.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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HARS subscale scores: psychic anxiety and somatic anxiety
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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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.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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FFMQ subscale scores
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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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.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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Heart rate (HR)
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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Heart rate measured using the "Reacor" system as part of functional diagnostics.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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EEG alpha rhythm power (alpha index)
기간: Baseline, immediately after 10 day treatment, and at one month follow up.
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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.
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Baseline, immediately after 10 day treatment, and at one month follow up.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anastasia Kotelnikova, Dr. Sc. (Psychology), I.M. Sechenov First Moscow State Medical University (Sechenov University)
간행물 및 유용한 링크
일반 간행물
- 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.).]
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1323-2022
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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