Sleep and Mindfulness Program for Aging

Overseen By Rebecca Robbins, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Severe cognitive impairment

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

Compensation: Varies

Number of Visits: 4

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults sleep better and improve their quality of life and mental sharpness. It combines a sleep health program with mindfulness techniques to address challenges faced by seniors in residential facilities. The trial is open to individuals aged 55 and older who live in these communities and do not have severe cognitive issues.

As an unphased trial, participants contribute to innovative research focused on enhancing senior well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this sleep and mindfulness intervention is safe for older adults?

Research has shown that mindfulness programs are generally safe for older adults. A review of 15 studies found these programs improved both physical and emotional well-being without causing serious side effects. Another study found that a mindfulness program helped older adults with sleep problems sleep better, again without any major negative effects. While researchers continue to study mindfulness and sleep health programs, current evidence suggests they are well-tolerated and safe for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for sleep issues in older adults, which often involve medication or cognitive therapy, the Sleep Health and Mindfulness Program combines sleep health education with mindfulness practices. This program is tailored specifically for older adults living in housing facilities, addressing their unique challenges and needs. Researchers are excited about this approach because it promotes a holistic lifestyle change rather than just addressing symptoms, potentially leading to more sustainable improvements in sleep quality and overall well-being.

What evidence suggests that this sleep and mindfulness intervention is effective for improving sleep and cognitive function in older adults?

Research has shown that mindfulness practices can greatly benefit older adults. For instance, one study found that a program called mindfulness-based stress reduction (MBSR) improved sleep and reduced depression. Another study demonstrated that mindfulness helped individuals with sleep issues achieve better rest. Additionally, mindfulness has been linked to improved mental health and reduced anxiety. These findings suggest that combining sleep health techniques with mindfulness, as in the Sleep Health and Mindfulness Program for Older Adults being tested in this trial, could enhance sleep and quality of life for older adults. ^{2 4 6 7 8}

Who Is on the Research Team?

Rebecca Robbins, PhD

Principal Investigator

PhD

Are You a Good Fit for This Trial?

This trial is for older adults aged 55 and above living in residential facilities, looking to improve their sleep, quality of life, and cognitive function. Those with severe cognitive impairment as determined by the MoCA test cannot participate.

Inclusion Criteria

I am 55 or older and live in a care facility.

Exclusion Criteria

Severe cognitive impairment according to the Montreal Cognitive Assessment (MoCA)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Design and Adaptation

Design and adapt a sleep, mindfulness, and sleep disorders education intervention for older adults

8 weeks

Pilot Study

Conduct a small pilot study to ascertain feasibility and acceptability of the Sleep Health and Mindfulness Program

6 months

Sessions at baseline, 2-months, and 6-months

Follow-up

Participants are monitored for sleep quality, cognitive function, and quality of life

6 months

Data collection at baseline, 2-months, and 6-months

What Are the Treatments Tested in This Trial?

Interventions

• Sleep health and mindfulness intervention

Trial Overview The study is testing a new program that focuses on improving sleep patterns and mindfulness among seniors. The goal is to see if this intervention can enhance overall well-being and mental sharpness.

How Is the Trial Designed?

Group I: Sleep Health and Mindfulness Program for Older Adults Experimental Treatment 1 Intervention

This grant will develop and design an adapted version of an existing, effective Sleep Health Program, which will be coupled with mindfulness content, to meet the needs and unique barriers older adults in housing facilities face. The modules for the proposed Sleep Health and Mindfulness program will be designed in collaboration with the implementation partner, the City of Boston Age Strong Commission, whose talented leaders and staff have decades of experience designing programs for seniors on a variety of topics, including mindfulness.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34415638/

Effectiveness of a mindfulness intervention for older adults ... At 2 months, intervention group reported better mental well-being (0.9, 95%CI: 0.1-1.8, p = 0.025) and less depressive symptoms (-1.0; 95%CI: -1.7 to -0.3, p = ...

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1242868/full

Effects of mindfulness-based cognitive therapy on older ... Results: Mindfulness was found to reduce poor sleep quality in people with both long-term and short-term sleep disorders. Weighting effect model Hedge'g = − ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17759-9

Effect of mindfulness-based stress reduction (MBSR) program ... The results of this study showed that MBSR can be effective in reducing depression levels, improving emotion regulation, and sleep quality among ...

4. academic.oup.com academic.oup.com/sleepadvances/article/6/4/zpaf056/8240159

a digital randomized control trial protocol for improving sleep ... For example, mindfulness meditation has been linked to enduring improvements in depressive symptoms [7, 53], mood [54], and anxiety [52] in adults from clinical ...

5. dovepress.com dovepress.com/the-effectiveness-of-a-mindfulness-based-art-therapy-program-on-sleep--peer-reviewed-fulltext-article-PPA

The Effectiveness of a Mindfulness-Based Art Therapy ... Conclusion: The MBAT program enhances relaxation for older adults, improving their sleep quality and mental health. It incorporates education on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4868399/

Mindfulness for Older Adults: Effects on Well-being The present review examined 15 studies investigating the effects of mindfulness-based interventions on physical and emotional wellbeing in older adults.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03677726

Study Details | NCT03677726 | Improving Sleep Continuity ... In this study, the investigators propose to test mindfulness-based training (MBT) as an intervention to improve sleep quality by reducing sleep ...

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

The effect of mindfulness meditation on sleep quality There was moderate strength of evidence that mindfulness meditation interventions significantly improved sleep quality compared with nonspecific active controls ...