Actively Recruiting
Mindfulness Meditation for Insomnia
Led by Brigham and Women's Hospital · Updated on 2026-02-25
30
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mindfulness Meditation for Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Chronic insomnia occurring 3 or more nights per week for at least 3 months, defined by DSM-V or ICSD-3
- Main complaint of difficulty falling asleep with sleep onset latency greater than 20 minutes
- Insomnia Severity Index score of 15 or higher
- Ability to speak and understand English
- Access to a smartphone or tablet capable of installing the mobile app
You will not qualify if you...
- Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder)
- Shift work or routine night shift work
- Pregnancy or breastfeeding for women
- Regular practice (twice a week or more) of mind-body interventions
- Use of pacemaker or cardiovascular medications affecting heart rate (e.g., beta-blockers)
- Neurological disorders such as epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors
- Current diagnosis of psychotic, substance use, or trauma-related disorders
- Use of medications that affect sleep such as anxiolytics, benzodiazepines, selective serotonin reuptake inhibitors, hypnotics
- Hearing impairment or hearing loss
- Must report any medication use for at least 2 weeks before and during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
Y
Yan Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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