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

Trial Summary

What is the purpose of this trial?

Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.

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.

What data supports the effectiveness of the treatment Mindfulness Meditation for Sleep Disorders?

Research shows that mindfulness meditation can help improve sleep quality and reduce sleep disturbances, particularly in people with insomnia and cancer patients. It combines meditation with behavioral strategies to manage sleep issues and has been shown to reduce stress and improve emotional regulation, which can contribute to better sleep. ^{1 2 3 4 5}

Is mindfulness meditation safe for treating sleep disorders?

Mindfulness meditation is generally considered safe, but some people may experience side effects like anxiety or discomfort. Severe reactions, such as psychosis, are rare and often linked to other factors like the intensity of practice or personal mental health history. Mindfulness programs are usually designed to be adaptable to avoid causing harm. ^{6 7 8 9 10}

How is mindfulness meditation different from other treatments for sleep disorders?

Mindfulness meditation is unique because it combines meditation practices with behavioral strategies to help manage stress and emotions, which can improve sleep quality. Unlike medications or other therapies, it focuses on developing awareness and acceptance of thoughts and feelings, which can help individuals adapt to sleep disturbances. ^{2 11 12 13 14}

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

Eligibility Criteria

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

I am between 18 and 20 years old.

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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

A mindfulness-based approach to the treatment of insomnia. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Strategies for Improving Sleep in People with Psychiatric Disorders. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using Mindfulness for the Treatment of Insomnia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

7. England 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

How mindfulness changed my sleep: focus groups with chronic insomnia patients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness meditation for chronic insomnia. [2022]

12. Switzerland 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. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Quest for Mindful Sleep: A Critical Synthesis of the Impact of Mindfulness-Based Interventions for Insomnia. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on adults with sleep disturbance: an updated systematic review and meta-analysis. [2022]