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

Background: 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.

Methods: 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 session; 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.

Discussion: 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. Trial registration ClinicalTrials.gov (NCTXXXXXXXXX)