Mindfulness Meditation for Insomnia

Overseen By Yan Ma

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brigham and Women's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with chronic insomnia, experiencing trouble falling asleep at least 3 nights a week for over 3 months. Participants must have an Insomnia Severity Index score of 15 or higher, speak English, and own a smart device to install the required app.

Inclusion Criteria

I have had trouble sleeping at least 3 nights a week for over 3 months.

I struggle to fall asleep, taking more than 20 minutes.

I have severe trouble sleeping.

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation

Trial Overview The study tests mindfulness meditation (MM) using an app at bedtime. There are three groups: one follows specific MM instructions, another uses MM without guidance, and the third receives sleep hygiene education only. The goal is to see if these methods improve sleep quality.

How Is the Trial Designed?

Group I: Uninstructed app-guided mindfulness meditation Experimental Treatment 2 Interventions

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.

Group II: Sleep Hygiene Education only Experimental Treatment 1 Intervention

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.

Group III: Instructed bedtime app-guided mindfulness meditation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+