Mindfulness Meditation for Insomnia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Instructed bedtime app-guided mindfulness meditation
- Uninstructed app-guided mindfulness meditation
- Sleep hygiene education
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov