340 Participants Needed

Mindfulness Therapy for Insomnia

(Project WISHES Trial)

ST
Overseen BySiobhan Thompson, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Mindfulness-based therapy for insomnia (MBTI)?

Research shows that Mindfulness-based therapy for insomnia (MBTI) can help improve sleep quality and reduce insomnia symptoms in older adults by decreasing the difference between how long they think it takes to fall asleep and how long it actually takes. This improvement is linked to increased mindfulness, which helps people become more aware and accepting of their thoughts and feelings, potentially leading to better sleep.12345

Is mindfulness therapy for insomnia safe for humans?

Mindfulness-based therapies for insomnia, like Mindfulness-Based Therapy for Insomnia (MBTI), have been studied in various trials and are generally considered safe for humans. These therapies focus on improving sleep through mindfulness practices and have not been associated with any significant safety concerns in the research available.12345

How is Mindfulness-based therapy for insomnia (MBTI) different from other treatments for insomnia?

Mindfulness-based therapy for insomnia (MBTI) is unique because it focuses on teaching mindfulness concepts through guided meditation and self-regulation practices, which help reduce cognitive arousal and improve sleep. Unlike traditional treatments like cognitive-behavioral therapy for insomnia (CBT-I), MBTI emphasizes mindfulness as a core component, offering an alternative approach for those who may not respond well to standard therapies.12467

What is the purpose of this trial?

The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.

Research Team

SN

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

Principal Investigator

Yale University School of Nursing

Eligibility Criteria

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.
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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.
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Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MBTIExperimental Treatment1 Intervention
Participants randomized to MBTI group.
Group II: ControlActive Control1 Intervention
Participants randomized to waitlist control group.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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]
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.
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]

References

Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. [2023]
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. [2022]
Increased high-frequency NREM EEG power associated with mindfulness-based interventions for chronic insomnia: Preliminary findings from spectral analysis. [2021]
A Meta-Analysis of Mindfulness-Based Therapies for Insomnia and Sleep Disturbance: Moving Towards Processes of Change. [2019]
Effects of mindfulness-based therapy for insomnia and a sleep hygiene/exercise programme on subjective-objective sleep discrepancy in older adults with sleep disturbances: Exploratory secondary analysis of a randomised clinical trial. [2022]
Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. [2022]
Mindfulness as an Adjunct or Alternative to CBT-I. [2023]
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