Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women.
Soohyun Nam, Guangyu Tong, Joanne Iennaco, Debbie Humphries, Monica Ordway, Minjung Lee, Siobhan Thompson, Milagrosa Seguinot, Fernando Morales, Kwasheba Harriot, Nilda Paris, Katurah A Bryant, Kristine Weidner, Taneha Edwards, Robin Whittemore
Contemporary Clinical Trials November 25, 2025 DOI: 10.1016/j.cct.2025.108166 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical protocol Randomized Qualitative Peer reviewed |
|---|---|
| Sample size | 340 |
| Population | Black women with insomnia in the U.S. |
| Intervention | Mindfulness-based therapy for insomnia (MBTI) |
| Measures | Insomnia Severity Index, actigraphy |
| Topics | Meditation |
| Keywords | Humans Qualitative research Adult Female Community health workers Stress Sleep Black women Health equity |
| Registration | NCT06348082 |
| Key points | The protocol proposes a community-engaged, equity-focused approach to adapting and implementing online group-based mindfulness-based therapy for insomnia for Black women, integrating community health workers to address social determinants of health. It aims to test whether this tailored intervention improves implementation outcomes (acceptability, feasibility, fidelity, cost) and effectiveness outcomes (Insomnia Severity Index reduction of at least 7 points; actigraphy-measured total sleep time increase of 20-40 minutes). |
Abstract
Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia (MBTI) tailored for Black women, and to test the effectiveness of MBTI. The study will utilize trained registered nurses to deliver the online MBTI sessions and integrate community health workers (CHWs) to address social determinants of health. This two-phase, study includes: (1) qualitative individual interviews with Black women, CHWs, and clinicians to identify barriers/facilitators to online MBTI (N = 10-40) (2) the development of equity-focused implementation strategies through community engagement process with the Community Advisory Board (clinicians, CHWs, social workers, and community-based organization members), and (3) a Hybrid Type 1 randomized controlled trial comparing online group-based MBTI to a waitlist control (N = 340). Implementation outcomes include acceptability (mean summary score ≥ 3.5 out of 5-point Likert scale), feasibility (≥ 80 %), fidelity (≥ 85 %), cost, and contextual factors; effectiveness outcomes include changes in Insomnia Severity Index scores (≥ 7-point reduction post-intervention) and actigraphy-measured sleep (an increase in total sleep time 20-40 min post-intervention). This study addresses the urgent need for equity-focused intervention and implementation research in sleep health. The study will evaluate how tailoring evidence-based interventions to community needs, leveraging CHWs, and embedding community partnership throughout the process improves access, uptake, and outcomes in Black women with insomnia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06348082.
Citations in the library
Cites 3
- Mindfulness-Based Interventions for Patients with Cardiovascular Disease: A Focused Review for Practicing Clinicians. Current cardiology reports March 2, 2023
- Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. Mindfulness February 2019
- Mind-Body Interventions to Reduce Risk for Health Disparities Related to Stress and Strength Among African American Women: The Potential of Mindfulness-Based Stress Reduction, Loving-Kindness, and the NTU Therapeutic Framework. Complementary health practice review December 14, 2010