Mindfulness Meditation for Insomnia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06972303
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Insomnia
  • Insomnia Chronic
  • Mindfulness
  • Sleep Initiation and Maintenance Disorders
  • Telemedicine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Instructed bedtime app-guided mindfulness meditation — BEHAVIORAL
    All participants will access the a smartphone app, and the mindfulness meditation practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. The investigators will provide instructions for participants who are assigned to practice at bedtime.
  • Uninstructed app-guided mindfulness meditation — BEHAVIORAL
    The guided mindfulness meditation practice will also be based on the same app. The investigators will not provide instructions for participants, and they have complete freedom to use the app as real-world users.
  • Sleep hygiene education — BEHAVIORAL
    Sleep hygiene education will be based on recognized, general, non-personalized sleep hygiene advice, for example, recommendations about bedtime routines and use of alcohol and caffeine, tips on creating a sleep-conducive bedroom environment.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Jul 31, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Instructed bedtime app-guided mindfulness meditation
    Participants will utilize the specific sleep program available within the app, which will include a choice of audio soundtracks for guided MM (no exposure to screen lights during practice). The practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. Participants will specifically use the app during the immediate pre-sleep period. They can choose their preferred meditation sessions within the Sleep menu in Week 1-4.
  • Experimental: Uninstructed app-guided mindfulness meditation
    Participants will be asked to practice MM using the same app during daytime (prior to the evening meal), but without specific study instructions around components to access or specific time of practice.
  • Other: Sleep Hygiene Education only
    Participants will receive sleep hygiene education and asked not to start any new insomnia treatments. Sleep hygiene education serves as a minimal intervention control condition and real-world comparator. At the end of the study, interested participants in the control group will be given equal access to the mobile app. Usual care for insomnia typically involves sleep hygiene education, so all three groups will receive standard SHE as part of usual care.

Primary Outcome Measure

Screened-to-eligible ratio [ Time Frame: Week 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Yan Ma

Find similar trials in Boston, MA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Brigham and Women's Hospital· Boston, MA

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