Pilot RCT Opens: App-Based Mindfulness Meditation vs Sleep Hygiene Education in Chronic Insomnia — Feasibility Data to Inform Future Digital Therapeutics Trial
247 Health News Editorial
·8 July 2026
·4 min read
·clinical-trialsA pilot randomised controlled trial at Brigham and Women's Hospital is evaluating the feasibility and acceptability of app-guided mindfulness meditation as a bedtime intervention for adults with chronic insomnia disorder. The three-arm study compares instructed and uninstructed mindfulness meditation against sleep hygiene education, with findings intended to inform the design of a future definitive efficacy trial. Clinicians managing patients with treatment-resistant or pharmacotherapy-ineligible insomnia should monitor this emerging digital therapeutics evidence base.
Originally reported by ClinicalTrials.gov
References
- 1.Brigham and Women's Hospital. (2025). A pilot feasibility and acceptability RCT of an app-based mindfulness meditation intervention for sleep among patients with insomnia disorder (NCT06972303). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06972303
- 2.Billingham, S. A. M., Whitehead, A. L., & Julious, S. A. (2013). An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Medical Research Methodology, 13, 104. https://doi.org/10.1186/1471-2288-13-104
- 3.Gong, H., Ni, C. X., Liu, Y. Z., Zhang, Y., Su, W. J., Lian, Y. J., Peng, W., & Jiang, C. L. (2016). Mindfulness meditation for insomnia: A meta-analysis of randomized controlled trials. Journal of Psychosomatic Research, 89, 1–6. https://doi.org/10.1016/j.jpsychores.2016.09.008
- 4.Morin, C. M., Belleville, G., Bélanger, L., & Ivers, H. (2011). The Insomnia Severity Index: Psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep, 34(5), 601–608. https://doi.org/10.5665/SLEEP.1544
- 5.Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125–133. https://doi.org/10.7326/M15-2175
- 6.Roth, T. (2007). Insomnia: Definition, prevalence, etiology, and consequences. Journal of Clinical Sleep Medicine, 3(5 Suppl), S7–S10. https://doi.org/10.5664/jcsm.26929
2
247 Health News Editorial
247 Health News is a medical intelligence platform delivering evidence-based research appraisals, clinical trial monitoring, and health technology news for healthcare professionals.
Related Articles
clinical-trials
Digital Health Platform vs Case Manager Support in Hypertension Management: Taiwan's 1,726-Participant Trial Signals a Shift in Blood Pressure Care Delivery
3 Aug 2026
clinical-trials
Phase II Trial: AI-Powered Wysa Chatbot vs Unmet Need — Digital Eating Disorder Prevention in At-Risk Adolescents
3 Aug 2026
clinical-trials
Pilot Trial Targets the Inpatient-to-Outpatient Gap: Digital Smoking Cessation Intervention for Persons With Serious Mental Illness — Key Findings for Clinicians
3 Aug 2026
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service