Mindfulness Meditation for Insomnia

The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.

NCT Number	NCT06972303
Lead Sponsor	Brigham and Women's Hospital Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions	Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Chronic, Mindfulness, Telemedicine
Enrollment	30 participants
Start Date	2026-03-31
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-12-29 (estimated)
Updated on ClinicalTrials.gov	2026-06-23