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)