Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women.
Soohyun Nam, Guangyu Tong, Joanne Iennaco...
https://pubmed.ncbi.nlm.nih.gov/41308952/Actively Recruiting
Led by Yale University · Updated on 2026-02-19
340
Participants Needed
2
Research Sites
8 weeks
Total Duration
This research aims to promote health and healthcare equity by testing an online mindfulness-based therapy designed to reduce stress and sleep problems linked to heart and metabolic diseases in Black women. The study focuses on understanding barriers and supports for this therapy through community involvement and aims to provide insights for better health policies and practices. The study includes two groups one receives the mindfulness-based therapy for insomnia MBTI in six weekly online sessions led by registered nurses, while the other is a waitlist control group. The MBTI sessions cover mindfulness concepts and practices to improve sleep, with daily meditation expected at home during and after the intervention. Social needs assessments are also part of the program. Participants will be evaluated at the start, week 6, and week 12 for changes in insomnia severity, stress levels, and how acceptable and feasible the intervention is. Treatment sessions will be monitored for fidelity. The total study period includes the intervention and follow-up assessments, with data collection on sleep, stress, and participant feedback to understand the therapys impact and implementation.
CONDITIONS
Project Women's Insomnia Sleep Health Equity Study (WISHES)
S
Siobhan Thompson, MPH
S
Soohyun Nam, phD
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Yale University
Lead Sponsor
Department of Health and Human Services
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | MBTI (trial arm) | Control (no intervention) | CBT‑I (guideline‑based care) |
|---|---|---|---|
| What it is | A structured mindfulness‑based therapy for insomnia delivered over weekly sessions | A control group receiving no active intervention | Cognitive behavioral therapy for insomnia (CBT‑I) is the guideline‑recommended first‑line non‑drug treatment for chronic insomnia |
| Role in the trial | Investigational behavioral therapy arm | Control arm with no intervention | An active behavioral treatment commonly used in clinical care though not included in this trial |
| Primary use | To address insomnia symptoms through mindfulness and behavioral techniques | Serves as comparison to measure MBTI effects | Used widely to improve insomnia using cognitive and behavioral strategies |
| How it is given or performed | Delivered in weekly sessions with formal mindfulness practice and behavioral strategies for sleep | No sessions or intervention provided | Typically delivered in multiple sessions combining behavioral and cognitive components |
| Evidence status | Efficacy not yet established; trial is ongoing | No expected active effect; serves as baseline comparator | Supported by clinical practice guidelines as first‑line treatment for chronic insomnia |
| Important limitations | Effectiveness in Black women specifically not yet known until trial results available | Does not reflect an active treatment | Access to CBT‑I may be limited in some communities |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants randomized to the Mindfulness-based therapy for insomnia (MBTI) group attend 6 weekly online sessions focused on mindfulness concepts and behavioral strategies for sleep. They are expected to practice mindfulness meditation at home daily during this period.
6 weekly sessions (online)
Duration - 6 weeks
Participants continue mindfulness practice at home with reduced daily meditation until the final assessment at 12 weeks.
Assessments at week 12 (online or in-person)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Soohyun Nam, Guangyu Tong, Joanne Iennaco...
https://pubmed.ncbi.nlm.nih.gov/41308952/Yale University
Lead Sponsor
Department of Health and Human Services
Collaborating Sponsor