Mindfulness Development via Biofeedback for Anxiety in Hospitalized Patients: A Randomized Controlled Trial
Anastasia V. Kotelnikova, Vera M. Ruzinova, Maria G. Kiseleva, Beatrice Volel, Anastasia A. Kukshina
Brain Sciences July 15, 2026 DOI: 10.3390/brainsci16070748 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 188 |
| Population | Inpatients with anxiety disorder (ICD10 F40/F41) |
| Interventions | Biofeedback for enhancing mindfulness Escitalopram |
| Dose | 10 mg/day |
| Duration | 10-day treatment, one-month follow-up |
| Topics | Anxiety Meditation |
| Keywords | Randomized controlled trial Rating scale Biofeedback Escitalopram Mindfulness-based stress reduction Physical therapy Clinical psychology |
| Registration | NCT07628153 |
| Key findings | Biofeedback, alone or combined with escitalopram, reduced anxiety and increased mindfulness more than escitalopram alone, with no significant difference between biofeedback and combined therapy. |
Abstract
Background: Anxiety disorders are prevalent and debilitating. Given challenges in maintaining mindfulness at one-month remission, integrative approaches targeting anxiety and psychological resources (especially mindfulness) have gained interest. This study aimed to assess the effectiveness of adding biofeedback to the treatment of anxiety disorders.
Methods: Inpatients with anxiety disorder (ICD10 F40/F41) were randomized to three groups: (1) biofeedback for enhancing mindfulness (BFB, n = 76); (2) medication therapy (MT, escitalopram 10 mg/day, n = 46); and (3) combined therapy (BFB + MT, CT, n = 66). Per-protocol analysis: 180 completers; ITT: all 188 randomized patients. The primary outcomes were changes in the Hamilton Anxiety Rating Scale (HAM-A) total score and the Five Facet Mindfulness Questionnaire total score, assessed at baseline, after 10 days of treatment, and at one-month follow-up. The HAM-A assessor was blinded to group allocation.
Results: In the per-protocol analysis, the BFB and CT groups showed a significantly greater reduction in the HAM-A score than the MT group did. For example, post-treatment, the mean difference between BFB and MT groups was –6.30 points (95% CI: –9.12 to –3.48, p = 0.00046). The BFB and CT groups did not differ significantly. For mindfulness, the BFB and CT groups showed an increase, whereas the MT group showed a decrease (BFB vs. MT: mean difference 30.28 points, 95% CI: 23.54–37.02, p < 0.000001). Intention-to-treat (ITT) analysis (n = 188) confirmed the robustness of these findings.
Conclusions: BFB appears to be a promising approach for reducing anxiety and fostering mindfulness skills; these findings suggest it may be worth exploring further as a potential component of comprehensive therapy for anxiety disorders. Clinical
Trial Registration: ClinicalTrials.gov NCT07628153 (retrospectively registered). The trial was retrospectively registered, and the primary analysis was conducted on a per-protocol population.
Comparable studies
Other randomized controlled trials on anxiety, most cited first.
Citations in the library
Cites 5
- Pharmacological Treatment of Generalised Anxiety Disorder: Current Practice and Future Directions. Expert Review of Neurotherapeutics June 1, 2023
- Mechanism of Action of Mindfulness-Based Interventions for Pain Relief-A Systematic Review. Journal of Integrative and Complementary Medicine December 1, 2024
- Does mindfulness-based cognitive therapy with tapering support reduce risk of relapse/recurrence in major depressive disorder by enhancing positive affect? A secondary analysis of the PREVENT trial. Journal of Consulting and Clinical Psychology September 1, 2024
- Effectiveness of Neurofeedback-Assisted and Conventional 6-Week Web-Based Mindfulness Interventions on Mental Health of Chinese Nursing Students: Randomized Controlled Trial. Journal of Medical Internet Research May 23, 2025
- Mindfulness meditation alters alpha amplitude without affecting arousal. International Journal of Psychophysiology June 14, 2025