Implementing "Community-based approach for lowering stress through mindfulness in Chicago" (CALM-Chicago) for depression and hypertension: Study protocol of a proof-of-concept trial.
8 affiliations
- 1Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
- 2Total Resource Community Development Organization, Chicago, IL, USA.
- 3The University of Kansas, Lawrence, KS, USA.
- 4Washington University School of Medicine, St. Louis, MO, USA.
- 5The George Institute for Global Health, UNSW Sydney, Australia.
- 6University of Abuja, Abuja, Nigeria.
- 7Spencer Fox Eccles School of Medicine at the University of Utah, Salt Lake City, UT, USA.
- 8Illinois Department of Human Services, Chicago, IL, USA.
Abstract
Community-based mental health interventions hold potential to reach communities who are less likely to engage in traditional clinic-based services. Partnering with community members and organizations to develop a community-informed approach increases the likelihood of successful implementation of these interventions. We will evaluate the effectiveness and implementation of an adapted mindfulness-based stress reduction intervention among Black/African American adults with comorbid depression and hypertension. This trial is a single-arm, type 1 hybrid effectiveness-implementation study. We will recruit Black/African American adults (≥18 years) with elevated depressive symptoms (PHQ-9 scores ≥10) and a self-reported diagnosis of hypertension. All participants will be enrolled in an 8-week mindfulness-based stress reduction program that has been adapted for Black/African American adults, heart health, and community-based delivery. Study participants will complete surveys at baseline and at 4 weeks and 8 weeks post-baseline; blood pressure readings before and after the first and final mindfulness sessions; and a post-intervention focus group. We will also recruit community members to a community advisory board to advise on trial execution, challenges, implementation, and evaluation. Primary effectiveness outcomes include effect sizes of changes in depressive symptoms (Patient Health Questionnaire-9 scores) and systolic blood pressure from baseline to 8 weeks. The primary implementation outcome of implementation acceptability, appropriateness, feasibility will be assessed using mixed qualitative-quantitative methods. Successful completion of this trial will provide preliminary evidence for the effectiveness of mindfulness for improving depression and blood pressure control as well as the implementation of community-based mindfulness programs. ClinicalTrials.gov (NCT06987799).
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BibTeX
@article{carroll2026implementing,
title = {{Implementing "Community-based approach for lowering stress through mindfulness in Chicago" (CALM-Chicago) for depression and hypertension: Study protocol of a proof-of-concept trial.}},
author = {Allison J Carroll and Paris Davis and Larissa R Reed and Asia Ellis and Namratha R Kandula and Abel N Kho and Quentin R Youmans and Carly M Maletich and Mark D Huffman and Justin D Smith and Inger E Burnett-Zeigler},
journal = {Contemporary clinical trials communications},
year = {2026},
month = oct,
doi = {10.1016/j.conctc.2026.101702},
url = {https://europepmc.org/article/MED/42999674},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Implementing "Community-based approach for lowering stress through mindfulness in Chicago" (CALM-Chicago) for depression and hypertension: Study protocol of a proof-of-concept trial.
AU - Allison J Carroll
AU - Paris Davis
AU - Larissa R Reed
AU - Asia Ellis
AU - Namratha R Kandula
AU - Abel N Kho
AU - Quentin R Youmans
AU - Carly M Maletich
AU - Mark D Huffman
AU - Justin D Smith
AU - Inger E Burnett-Zeigler
PY - 2026
DA - 2026/10/27
JO - Contemporary clinical trials communications
DO - 10.1016/j.conctc.2026.101702
UR - https://europepmc.org/article/MED/42999674
AB - Community-based mental health interventions hold potential to reach communities who are less likely to engage in traditional clinic-based services. Partnering with community members and organizations to develop a community-informed approach increases the likelihood of successful implementation of these interventions. We will evaluate the effectiveness and implementation of an adapted mindfulness-based stress reduction intervention among Black/African American adults with comorbid depression and hypertension. This trial is a single-arm, type 1 hybrid effectiveness-implementation study. We will recruit Black/African American adults (≥18 years) with elevated depressive symptoms (PHQ-9 scores ≥10) and a self-reported diagnosis of hypertension. All participants will be enrolled in an 8-week mindfulness-based stress reduction program that has been adapted for Black/African American adults, heart health, and community-based delivery. Study participants will complete surveys at baseline and at 4 weeks and 8 weeks post-baseline; blood pressure readings before and after the first and final mindfulness sessions; and a post-intervention focus group. We will also recruit community members to a community advisory board to advise on trial execution, challenges, implementation, and evaluation. Primary effectiveness outcomes include effect sizes of changes in depressive symptoms (Patient Health Questionnaire-9 scores) and systolic blood pressure from baseline to 8 weeks. The primary implementation outcome of implementation acceptability, appropriateness, feasibility will be assessed using mixed qualitative-quantitative methods. Successful completion of this trial will provide preliminary evidence for the effectiveness of mindfulness for improving depression and blood pressure control as well as the implementation of community-based mindfulness programs. ClinicalTrials.gov (NCT06987799).
SN - 2451-8654
ER -