Mindfulness Meditation for Insomnia

Mass General Brigham

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Sleep Initiation and Maintenance Disorders; Mindfulness; Insomnia; Telemedicine; Insomnia Chronic

Treatments: Behavioral: Instructed bedtime app-guided mindfulness meditation; Behavioral: Sleep hygiene education; Behavioral: Uninstructed app-guided mindfulness meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT06972303

N.A. yet

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Instructed bedtime app-guided mindfulness meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Sleep hygiene education

Behavioral: Instructed bedtime app-guided mindfulness meditation

Uninstructed app-guided mindfulness meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Uninstructed app-guided mindfulness meditation

Behavioral: Sleep hygiene education

Sleep Hygiene Education only

Other group

Description:

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.

Treatment:

Behavioral: Sleep hygiene education