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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06348082
Other study ID # 2000036068
Secondary ID 1R18HS029812-01
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2025
Est. completion date July 2028

Study information

Verified date April 2024
Source Yale University
Contact Siobhan Thompson, MPH
Phone 203.785.4222
Email siobhan.thompson@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

In phases 1 and 2, the investigator will identify multi-level barriers and facilitators to implementing the online mindfulness-based therapy for insomnia (MBTI) through an equity lens using community-engaged research with key stakeholders. The investigators will then develop and refine equity-focused implementation strategies with the community advisory board, comprised of community-based organization members, African Methodist Episcopal Zion Church networks, clinicians, and community health workers (CHWs). In phase 3, the investigators will use a Hybrid Type 1 effectiveness/implementation design with a pragmatic randomized controlled trial with MBTI and a waitlist control in Black women with insomnia. Specialists will assess and address social needs of Black women, and registered nurses will deliver the online MBTI intervention in the community settings. The focus of this registration is phase 3. The study will contribute to equity-focused implementation science and policy decisions by providing multi-level implementation determinants, equity-relevant metrics, and contextual factors through community-engaged research and evaluation of the outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 340
Est. completion date July 2028
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - self-identified Black women - English speaking - meet ICSD3 diagnostic criteria for insomnia disorders, defined as difficulty initiating or maintaining sleep that occurs despite adequate opportunity to sleep with at least one associated daytime impairment symptom (ISI > 7) - 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. 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) - significant current practice of any form of meditation (>15min per day) - obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, use of medication that influence circadian rhythm, e.g., Parkinson's disease) - active or terminal cancer.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-based therapy for insomnia (MBTI)
MBTI will be administered in 8 weekly sessions. Session 1 consists of introductions and an overview. Subsequent sessions consist of mindfulness concepts/practice and behavioral strategies for sleep. Each session will begin with guided formal meditation followed by discussion. Mindfulness practice (at home) expectations are 30-45 minutes of meditation/day at least 5 days during the period of the intervention, followed by 20 minutes/day until the final follow-up assessment (at 16 weeks). Mindfulness concepts: Overview of Mindfulness, Mindfulness of the Body, Obstacles to Mindfulness,Working with Difficult Emotions, Cultivating Positive Emotions, Working with Difficult Thoughts, Mindful Interactions.

Locations

Country Name City State
United States Yale School of Nursing Biobehavioral Lab West Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insomnia Severity Change in Insomnia severity or remission will be assessed using the Insomnia Severity Index (ISI). The ISI is a 7 item survey used to determine insomnia severity. Total score range from 0-28 with cutoffs as follows: no insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). Response to the MBTI on the ISI will be defined as a meaningful change of 7 or more points from baseline, or remission as reduction to a score less than 8. baseline, week 8 and week 16
Primary Change in Perceived Stress Change will be assessed using the Perceived Stress Scale (PSS -10) Total score range from 0-40 with cutoffs as follows: low perceived stress (0-13); moderate perceived stress (14-26); high perceived stress (27-40). Response to the MBTI on the PSS will be defined as a meaningful change of 5 or more points from baseline, or remission as reduction to a score less than 13. baseline, week 8 and week 16
Primary Acceptability of Intervention (AIM) Acceptability of the implementation strategy will be assessed using the Acceptability of Intervention measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability. week 8 and week 16
Primary Feasibility of Intervention (FIM) Feasibility of the implementation strategy will be assessed using the Acceptability of Intervention measure (FIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate higher likelihood of feasibility. week 8 and week 16
Primary Treatment Fidelity Fidelity to the MBTI intervention will be scored using The Mindfulness-Based Relapse Prevention Adherence and Competence Scale (MBRP-AC), a treatment fidelity checklist tool for mindfulness interventions. Specifically, staff trained to observe key components of intervention delivery will complete a checklist of items that correspond to each session (n=8) to evaluate the fidelity to the intervention protocol. Summary scores will reflect the higher the percentage of key components checked off, the higher the fidelity to the treatment intervention protocol. Weeks 1-8 intervention training sessions
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