Mindfulness Therapy for Insomnia
(Project WISHES Trial)
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the online mindfulness-based therapy for insomnia (MBTI) intervention
Follow-up
Participants are monitored for changes in insomnia severity and perceived stress
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness-based therapy for insomnia (MBTI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Department of Health and Human Services
Collaborator