Mindfulness Therapy for Insomnia

(Project WISHES Trial)

Overseen By Siobhan Thompson, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychotropic, Circadian rhythm

Disqualifiers: Psychosis, Depression, Anxiety, Cancer, others

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

Compensation: Varies

Number of Visits: 14

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness-based therapy can reduce stress and improve sleep in Black women with insomnia. The research examines how improved sleep might lower the risk of heart disease and related health issues. Participants will either engage in mindfulness-based therapy for insomnia (MBTI) or join a waitlist group for comparison. It suits Black women who struggle with sleep at least three nights a week and face daytime issues as a result. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance sleep and overall health for Black women.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking more than one psychotropic medicine daily, you may not be eligible to participate.

What prior data suggests that mindfulness-based therapy for insomnia is safe?

Research has shown that mindfulness-based therapy for insomnia (MBTI) is generally safe. Studies have found that MBTI improves sleep without causing major side effects. In past research, participants reported better sleep quality, with no serious negative effects linked to the therapy.

MBTI combines mindfulness techniques with behavior therapy to address insomnia, focusing on relaxation and awareness. These gentle, non-invasive methods are well-tolerated by most people. Since this trial does not involve a new drug or invasive treatment, it is considered quite safe.

Overall, existing evidence suggests that MBTI is a safe option for those seeking to improve sleep through mindfulness techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-based therapy for insomnia (MBTI) is unique because it offers a non-drug approach to managing insomnia, unlike standard treatments that typically involve medication or cognitive behavioral therapy. This therapy uses mindfulness techniques to help individuals become more aware of their thoughts and feelings, potentially reducing the stress and anxiety that often contribute to sleeplessness. Researchers are excited about MBTI because it could provide a holistic, sustainable solution to insomnia without the side effects associated with medication, offering a new avenue for those who haven't found success with traditional treatments.

What evidence suggests that mindfulness-based therapy for insomnia is effective for reducing stress and sleep deficiency-related cardiometabolic disease burden in Black women?

Research shows that mindfulness-based therapy for insomnia (MBTI), which participants in this trial may receive, can improve sleep. Studies have found that people sleep more efficiently, spending less time awake at night. One study found that these improvements lasted for 6 to 12 months after therapy. MBTI has also reduced symptoms of insomnia, depression, and mental alertness. These findings suggest that MBTI could be a promising option for those struggling with insomnia. ^{3 6 7 8 9}

Who Is on the Research Team?

Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN

Principal Investigator

Yale University School of Nursing

Are You a Good Fit for This Trial?

This trial is for Black women who are experiencing insomnia and may have cardiometabolic syndrome, which includes conditions like heart disease and diabetes. Participants should be interested in trying a mindfulness-based therapy to improve their sleep.

Inclusion Criteria

English speaking

I am a Black woman.

Additional quantitative insomnia criteria based on research recommendations and the new ICSD3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31 min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months.

Exclusion Criteria

Psychosis or unstable/significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)

I meditate for more than 15 minutes daily.

I have sleep apnea, restless legs, or a condition affecting my sleep/wake cycle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the online mindfulness-based therapy for insomnia (MBTI) intervention

6 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for changes in insomnia severity and perceived stress

6 weeks

Assessments at week 6 and week 12

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-based therapy for insomnia (MBTI)

Trial Overview The study is testing Mindfulness-Based Therapy for Insomnia (MBTI), aiming to reduce stress and the risk of diseases related to poor sleep among participants by teaching them techniques to enhance their sleep quality.

How Is the Trial Designed?

Group I: MBTI Experimental Treatment 1 Intervention

Participants randomized to MBTI group.

Group II: Control Active Control 1 Intervention

Participants randomized to waitlist control group.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) have been shown to effectively improve sleep and reduce cognitive arousal, which are key factors in managing insomnia.

The article suggests that MBIs can be used as an adjunct or alternative treatment to cognitive behavioral therapy for insomnia (CBT-I), highlighting their potential role in enhancing sleep treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as an Adjunct or Alternative to CBT-I. Ong, JC., Kalmbach, DA.[2023]

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 Therapy for Insomnia (MBTI) significantly reduced insomnia severity more than the Sleep Hygiene, Education, and Exercise Program (SHEEP) in a study of 127 older adults, indicating its effectiveness as a treatment option.

MBTI also improved objective sleep measures, such as wake after sleep onset and sleep onset latency, while no participants experienced adverse effects, suggesting it is a safe alternative for those struggling with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. Perini, F., Wong, KF., Lin, J., et al.[2023]

Mindfulness-Based Therapy for Insomnia (MBTI) improved self-reported sleep quality and significantly increased N2 sleep, while the sleep hygiene education and exercise program (SHEEP) led to improvements in N3 sleep, indicating that both interventions have unique benefits for sleep architecture.

The study, involving 94 participants and using ambulatory polysomnography to measure sleep changes, suggests that mindfulness training may work through different mechanisms compared to traditional sleep interventions, as evidenced by the distinct effects on sleep macroarchitecture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissociable changes in sleep architecture with mindfulness and sleep hygiene intervention in older adults: Secondary and exploratory analysis of polysomnography data from the Mindfulness Sleep Therapy (MIST) trial. Wong, KF., Perini, F., Lin, J., et al.[2022]

Citations

1. med.upenn.edu med.upenn.edu/cbti/assets/user-content/documents/Ong_Mindfulness-BasedTherapyforInsomnia-BTSD.pdf

Mindfulness-Based Therapy for Insomnia | MBTI Follow-up data revealed that the acute treatment gains achieved at the end of treatment were maintained at 6 and 12 months post- treatment, and 61 percent of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6171769/

Using Mindfulness for the Treatment of Insomnia - PMC Data across the 3 studies that used actigraphy showed an increase of sleep efficiency from 1% to 2%, a decrease in total wake time between 11 to ...

3. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1072752/full

Mindfulness-based therapy for insomnia alleviates ... Mindfulness-based therapy for insomnia alleviates insomnia, depression, and cognitive arousal in treatment-resistant insomnia: A single-arm ...

4. e-jyms.org e-jyms.org/journal/view.php?number=2628

Effects and mechanisms of a mindfulness-based ... In the meta-analysis results of MBI insomnia published in 2020, participants in the MBI group showed a significant improvement in insomnia as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8342656/

A Randomized Controlled Trial to Examine the Feasibility ... This study provides preliminary evidence of the feasibility and efficacy of a digital MBTI, which may assist in the broader dissemination of insomnia treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153063/

A Randomized Controlled Trial of Mindfulness Meditation ... It was hypothesized that MBTI would show relative benefits on sleep measures compared to MBSR on acute and long-term outcomes. Together, these aims were ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03724305

NCT03724305 | Reduce Emotional Symptoms of Insomnia ... The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal ...

8. academic.oup.com academic.oup.com/sleep/article/43/Supplement_1/A198/5846931

Preliminary Data from the Mindfulness Sleep Therapy (MIST ... Mindfulness-based treatment for insomnia (MBTI) is a viable intervention for improving poor sleep. We report preliminary data from an ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5300077/

The Quest for Mindful Sleep: A Critical Synthesis of ... This paper provides a critical appraisal of this growing area investigating the application of MBIs for people with insomnia and sleep disturbance.