drugset / Trial / NCT07628153

Mindfulness and Biofeedback for Anxiety Disorders

NCT07628153

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Publications

  • Background 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.).]

Drugs

EvaluationDrugModalityDoseRoute
Comparator Escitalopram Small molecule 10 mg Oral

Indications