Mindfulness Meditation for Sleep Disorders

(REST Trial)

Overseen By Deborah E Garet, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anti-inflammatories

Disqualifiers: Mood disorder, Anxiety disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness meditation can improve sleep in first-year college students with sleep issues. Participants will be divided into two groups: one will practice mindfulness meditation, and the other will receive sleep education. The goal is to identify which method more effectively reduces sleep problems and enhances overall well-being. The study seeks first-year UCLA students living in dorms who experience significant sleep disturbances.

As an unphased trial, this study provides participants the opportunity to explore innovative methods for improving sleep and well-being.

Will I have to stop taking my current medications?

The trial excludes participants who use medications that may influence sleep or inflammation, so you may need to stop taking such medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that mindfulness meditation is generally safe and easy for most people. Research examining over 200 studies found that mindfulness-based therapy effectively reduces stress, with few risks reported. Another study focused on mindfulness meditation for sleep problems and found it might help improve sleep quality. However, more research is needed to fully understand any possible negative effects. Overall, mindfulness meditation is considered a low-risk option for improving health, making it a promising choice for those looking to enhance their sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness Meditation for sleep disorders because it offers a natural, non-pharmacological approach to improving sleep quality. Unlike traditional treatments like sleeping pills or cognitive behavioral therapy, mindfulness meditation focuses on enhancing awareness and relaxation, which can promote better sleep without the risk of side effects or dependency. This method encourages participants to develop skills in mindfulness that can lead to long-term improvements in sleep patterns and overall well-being.

What evidence suggests that this trial's treatments could be effective for sleep disorders?

Research has shown that mindfulness meditation, which participants in this trial may receive, can improve sleep quality. Studies have found that practices like Mindful Awareness Practices (MAPs) lead to noticeable improvements in insomnia and related sleep issues. Specifically, one study found a large positive impact, indicating a meaningful improvement in sleep quality. The data from these studies suggest that mindfulness meditation could be a promising way to treat sleep problems. These findings support its potential effectiveness in improving sleep among college students. Meanwhile, another group in this trial will receive Sleep Education, serving as an active comparator to evaluate the effectiveness of mindfulness meditation. ^{2 6 7 8 9}

Who Is on the Research Team?

Julienne E Bower, Ph.D.

Principal Investigator

University of California, Los Angeles

Andrew Fuligni, Ph.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

The UCLA REST Study is for first-year undergraduate students at UCLA, aged 18-20, living in campus dorms and experiencing sleep issues as indicated by a score of 8+ on the Insomnia Severity Index. Students with mood or anxiety disorders, certain medical conditions, or prior mindfulness meditation instruction are not eligible.

Inclusion Criteria

Must live in the residential halls on UCLA campus

Must have a score of 8 or above on the Insomnia Severity Index (ISI), indicating at least sub-threshold levels of sleep disturbance.

I am a first-year undergraduate student at UCLA.

Exclusion Criteria

I have taken mindfulness meditation classes or am in a sleep education program.

I have a condition or take medication that affects my sleep or causes inflammation.

I have been diagnosed with a mood or anxiety disorder based on specific test scores.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Eligible participants complete baseline assessments including questionnaires, blood samples, and actigraphy setup

1 week

1 visit (in-person)

Treatment

Participants attend weekly group sessions for Mindful Awareness Practices or Sleep Education over six weeks

6 weeks

6 visits (in-person)

Immediate Post-Intervention Assessment

Participants complete post-intervention assessments including questionnaires, blood samples, and actigraphy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects with assessments at 3, 6, and 12 months post-intervention

12 months

3 visits (1 in-person, 2 virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation
• Sleep Education

Trial Overview This study tests whether a six-week group-based mindfulness program (MAPs) can improve sleep and reduce inflammation compared to standard sleep education. It involves questionnaires, blood samples for immune analysis, and wrist actigraphs to track sleep before and after the intervention plus follow-ups.

How Is the Trial Designed?

Group I: Mindfulness Meditation Experimental Treatment 1 Intervention

Half of the subjects will be randomly assigned to participate in the Mindfulness Meditation intervention. This class will meet once a week, for two hours, over the course of six weeks.

Group II: Sleep Education Active Control 1 Intervention

Half of the subjects will be randomly assigned to participate in the Sleep Education intervention. This class will meet once a week, for two hours, over the course of six weeks.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Mindfulness meditation, specifically mindfulness-based therapy for insomnia (MBTI) and mindfulness-based stress reduction (MBSR), significantly reduced total wake time, pre-sleep arousal, and insomnia severity in adults with chronic insomnia compared to a self-monitoring control group, with 54 participants involved in the study.

MBTI showed superior long-term efficacy, achieving a 50% remission rate and 78.6% response rate at the 6-month follow-up, suggesting mindfulness meditation could be a viable alternative to traditional insomnia treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness meditation for chronic insomnia. Ong, JC., Manber, R., Segal, Z., et al.[2022]

Mindfulness-based cognitive therapy for insomnia (MBCT-I) showed a significant short-term reduction in insomnia severity compared to a sleep psycho-education with exercise control (PEEC) group, with a notable effect size at 2 months.

While MBCT-I improved wake time after sleep onset at 2 and 5 months, both MBCT-I and PEEC groups exhibited similar long-term improvements in sleep parameters by 8 months, indicating that MBCT-I may not provide sustained benefits over PEEC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. Wong, SY., Zhang, DX., Li, CC., et al.[2022]

Mindfulness-based stress reduction (MBSR) shows promise as an effective intervention for improving sleep quality in individuals with insomnia, as highlighted by recent randomized controlled trials (RCTs).

This systematic review aims to synthesize current evidence on MBSR's effects on sleep disturbances, providing valuable insights for healthcare providers and the general public in selecting evidence-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction for adults with sleep disturbance: a protocol for an update of a systematic review and meta-analysis. Kim, SM., Park, JM., Seo, HJ.[2018]

An 8-week mindfulness-based stress reduction (MBSR) program helped participants with chronic insomnia improve their sleep quality, leading to feelings of being more refreshed and less distressed about their insomnia, even if they weren't sleeping longer.

Participants reported that mindfulness practices, especially the body scan technique, were effective in helping them fall asleep faster and that group support was crucial for maintaining motivation and behavioral changes related to sleep hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How mindfulness changed my sleep: focus groups with chronic insomnia patients. Hubbling, A., Reilly-Spong, M., Kreitzer, MJ., et al.[2021]

Mindfulness-based therapy for insomnia (MBT-I) combines behavioral treatments with mindfulness meditation to help individuals with chronic sleep disturbances.

Preliminary evidence suggests that MBT-I can effectively aid in emotion regulation and stress reduction, offering a novel approach to managing insomnia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based approach to the treatment of insomnia. Ong, J., Sholtes, D.[2021]

Mindfulness-Based Interventions (MBIs) are gaining attention for their potential to improve insomnia and sleep disturbances, suggesting a promising alternative to traditional treatments.

The paper reviews literature from 2012 to 2016, highlighting how mindfulness practices may positively influence sleep processes, although further research is needed to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Quest for Mindful Sleep: A Critical Synthesis of the Impact of Mindfulness-Based Interventions for Insomnia. Garland, SN., Zhou, ES., Gonzalez, BD., et al.[2020]

Mindfulness-based stress reduction (MBSR) did not show significant improvements in sleep quality for adults with chronic insomnia or cancer, based on a systematic review of 20 randomized controlled trials involving 7516 records.

While MBSR may have some subjective benefits compared to waitlist controls, the overall effectiveness is uncertain due to substantial variability in results and concerns about bias in the included studies, highlighting the need for larger, well-designed trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on adults with sleep disturbance: an updated systematic review and meta-analysis. Kim, SM., Park, JM., Seo, HJ., et al.[2022]

Mindfulness-based interventions show promise in improving sleep for individuals with psychiatric disorders, particularly in those with anxiety and depression, although the evidence is still limited.

There is a need for more well-controlled studies specifically designed to target sleep through mindfulness strategies, as current improvements may be more related to reductions in psychiatric symptoms rather than direct effects on sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Strategies for Improving Sleep in People with Psychiatric Disorders. Peters, AL., Saunders, WJ., Jackson, ML.[2023]

Mindfulness meditation programs have been shown to significantly reduce stress, anxiety, depression, and burnout among nurses and nursing students, enhancing their overall well-being and empathy.

The review included 16 studies, but most were small-scale, which limits the generalizability of the findings; larger and more rigorous studies are needed to confirm these benefits in broader nursing populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. van der Riet, P., Levett-Jones, T., Aquino-Russell, C.[2022]

Mindfulness meditation has emerged as a promising treatment for insomnia, supported by recent randomized controlled trials that show significant effects on self-reported sleep quality.

While mindfulness-based therapies are effective, especially in reducing insomnia-related arousal, more research is needed to understand their mechanisms and to identify which individuals may benefit the most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Mindfulness for the Treatment of Insomnia. Ong, JC., Smith, CE.[2022]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6557693/

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. Further research is warranted.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9048455/

Effects of mindfulness-based intervention programs on ... All MBI programs (MBTT, MBCT, IMMI and MBSR), except MM, are effective options to improve sleep problems among people with depression or anxiety disorder.

3. uclahealth.org uclahealth.org/programs/uclamindful/about-us/research/maps-research

Mindful Awareness Practices (MAPs) Research at MARC Both groups showed statistically significant improvements in depression, insomnia, and negative affect during the six weeks (all p. <0.05), but only the MAPs ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S096522992100008X

The mindfulness-based stress reduction program for ... MBSR significantly improved sleep quality compared to usual care (standardized mean difference −0.29, 95 % confidence interval −0.55 to −0.04, I2 = 58 %).

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2110998

Mindfulness Meditation and Improvement in Sleep Quality ... The effect size of 0.89 for improvement in sleep quality was large and of clinical relevance considering that effect sizes obtained from all ...

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH Meditation and mindfulness practices usually are considered to have few risks. However, few studies have examined these practices for potentially harmful ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00768781

NCT00768781 | Mindfulness-Based Approaches to Insomnia The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia ...

8. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Researchers reviewed more than 200 studies of mindfulness among healthy people and found mindfulness-based therapy was especially effective for reducing stress ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769761

Effect of a Brief Mindfulness-Based Program on Stress in ... This randomized clinical trial examines the effect of a brief mindfulness-based program on stress reduction among health care professionals ...