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 a
| Condition(s) | Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Chronic, Mindfulness, Telemedicine |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Age 18 years and older; * Chronic insomnia (≥ 3 nights/week, for ≥ 3 months), defined by DSM-V or ICSD-3; * Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency \>20 min; * Insomnia Severity Index score ≥ 15; * Speak and understand English; * Have a smart device (phone or tablet) for mobile app installation Exclusion Criteria: * Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.); * Shift worker or routine night shifts; * Women with pregnancy or breastfeeding; * Regular (defined as twice a week or more) practice of mind-body interventions; * Patients with pace-maker or routinely using cardiovascular medications that have effe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Brigham and Women's Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2026-02 |
| NCT ID | NCT06972303 |
| Official listing | https://clinicaltrials.gov/study/NCT06972303 |