Mindfulness Meditation for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether mindfulness meditation can improve sleep for people with chronic insomnia. Participants will join one of three groups: one will practice guided meditation at bedtime, another will meditate without specific instructions during the day, and the third will receive only sleep hygiene education. The researchers aim to determine which approach best aids falling asleep and enhances overall sleep quality. Individuals who have struggled with falling asleep for at least three months and possess a smart device for app use might be suitable candidates. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
Yes, if you are currently taking medications that affect sleep, like anxiety medications or antidepressants, you will need to stop them at least 2 weeks before the study starts and during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that mindfulness meditation (MM) is generally safe and may help with sleep problems. Studies have found that MM can improve sleep quality and reduce insomnia. For instance, one study found that MM helped people feel less anxious before bed, leading to better sleep.
Mindfulness meditation poses no major safety concerns. It is a gentle practice that involves focusing the mind and often includes breathing exercises or visualizing calming images, making it easy for most people to do.
For those considering joining a trial that includes mindfulness meditation, current evidence suggests it's a safe choice with potential benefits for sleep.12345Why are researchers excited about this trial's treatments?
Researchers are excited about mindfulness meditation as a treatment for insomnia because it offers a drug-free approach to improving sleep. Unlike traditional treatments, such as medications or cognitive behavioral therapy, mindfulness meditation can be conveniently accessed through an app and practiced at home. This trial is exploring two unique approaches: one that guides users through meditation right before sleep, and another that encourages meditation earlier in the day. Both methods aim to enhance relaxation and reduce stress, potentially improving sleep quality without the side effects associated with medications. This innovative use of technology and focus on holistic well-being are what make these treatments particularly promising.
What evidence suggests that this trial's treatments could be effective for insomnia?
Research has shown that mindfulness meditation can improve sleep and reduce insomnia. In this trial, participants will use a meditation app in different ways. One group will use the app for instructed bedtime mindfulness meditation, which may include techniques such as breathing exercises and relaxation. Another group will practice uninstructed app-guided mindfulness meditation during the daytime. Studies have found that both guided and unguided meditation apps can enhance sleep quality and lessen insomnia symptoms.46789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to 4 weeks of instructed bedtime mindfulness meditation, uninstructed mindfulness meditation, or sleep hygiene education
Follow-up
Participants are monitored for changes in sleep outcomes and adherence to intervention protocol
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?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Citations
Bedtime App–Guided Mindfulness Meditation in Patients ...
Benefits and skills imparted by mindfulness included decreased catastrophizing, acceptance and nonreactivity, body awareness and relaxation, ...
NCT06972303 | Mindfulness Meditation for Insomnia
The investigators will provide instructions for participants who are assigned to practice at bedtime. Other Names: Uninstructed bedtime app-guided mindfulness ...
3.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41027036/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1pq-4TZ0w1pIimA2HHLJZYTkSjaU335U-aRSFRxJ31Blahz9sN&fc=20220524061305&ff=20250930222922&v=2.18.0.post9+e462414Bedtime App-Guided Mindfulness Meditation in Patients ...
Participants practiced MM guided by a commercially available smartphone app at bedtime for 4 weeks. Pre-post assessments included a battery of ...
Award Information | HHS TAGGS
App-guided bedtime mindfulness for insomnia - PROJECT SUMMARY This K23 award will support the candidate's training and development towards an independent ...
Testing a mindfulness meditation mobile app for the treatment ...
This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep ...
The effect of mindfulness meditation on sleep quality
These preliminary findings suggest that mindfulness meditation may be effective in treating some aspects of sleep disturbance.
Mindfulness meditation for insomnia: A meta-analysis of ...
The results suggest that MM may mildly improve some sleep parameters in patients with insomnia. MM can serve as an auxiliary treatment to medication for sleep ...
Bedtime App–Guided Mindfulness Meditation in Patients ...
Our preliminary analysis of subjective measures indicated improvement in sleep quality, insomnia severity, and presleep arousal, including.
A Randomized Controlled Trial of Mindfulness Meditation for ...
Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for ...
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