Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Mindfulness and Biofeedback for Anxiety Disorders

1 juin 2026 mis à jour par: I.M. Sechenov First Moscow State Medical University

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

188

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: "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.
Comparateur actif: 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).
Médicament: 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).
Expérimental: 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.
Produit combiné: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Hamilton Anxiety Rating Scale (HARS) total score
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
HARS subscale scores: psychic anxiety and somatic anxiety
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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)
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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)
Délai: Baseline, immediately after 10 day treatment, and at one month follow up.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

I.M. Sechenov First Moscow State Medical University

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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.).]

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 juillet 2022

Achèvement primaire (Réel)

24 février 2025

Achèvement de l'étude (Réel)

24 février 2025

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1323-2022

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner