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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 effects on heart rates (i.e., beta-blockers); - Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders; - Currently under medications with sleep changing effects (e.g., anxiolytics/benzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.); - Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Instructed bedtime app-guided mindfulness meditation
    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.
    Other names:
    • Uninstructed bedtime app-guided mindfulness meditation
    • Sleep hygiene education
  • Behavioral: Sleep hygiene education
    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.
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.
  • Behavioral: Uninstructed app-guided mindfulness meditation
    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.
  • Behavioral: Sleep hygiene education
    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.
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.
  • Behavioral: Sleep hygiene education
    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.

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02215
Contact:
Yan Ma

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Yan Ma
(617) 732-8544
yanma@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.