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Community-based Approach to Lowering Stress Through Mindfulness

NCT06987799 · Northwestern University
In plain English

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Official title
Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science
About this study
The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are: * Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms? * Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control? * Is the intervention acceptable, appropriate, and feasible as delivered in a community setting? Participants will: * Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation. * Complete surveys online * Have their blood pressure measured with a non-invasive blood pressure cuff * Attend 1 focus group (optional)
Eligibility criteria
Inclusion Criteria: * ≥18 years old * Lives, works, or spends much of their time in the South Side of Chicago neighborhood * Self-reports diagnosis of hypertension or high blood pressure by a clinician * Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10 * Not taking antidepressant medication or stable on antidepressant medication for ≥6 months as self-reported Exclusion Criteria: * \<18 years old * Severe mental illness (e.g., bipolar disorder, psychosis) * Current suicidal ideation (PHQ-9 item 9) or recent (past 6 months) suicide attempt * Unable to provide informed consent or complete study activities in English
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-10
Estimated completion: 2028-05-31
Last updated: 2026-04-13
Interventions
Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)
Primary outcomes
  • Effectiveness: Depressive Symptom Response (From enrollment to the end of treatment at 8 weeks)
  • Effectiveness: Systolic Blood Pressure Response (From enrollment to the end of treatment at 8 weeks)
  • Implementation: Acceptability (Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years)
Sponsor
Northwestern University · other
With: National Heart, Lung, and Blood Institute (NHLBI), Total Resource Community Development Organization (TRCDO)
Contacts & investigators
ContactAsia Ellis, BA · contact · asia.ellis@northwestern.edu · 13125033569
InvestigatorAllison J Carroll, PhD · principal_investigator, Northwestern University
All locations (1)
The Salvation Army Ray and Joan Kroc Corps Community Center ChicagoRecruiting
Chicago, Illinois, United States
Community-based Approach to Lowering Stress Through Mindfulness · TrialPath