Community-based Approach to Lowering Stress Through Mindfulness (CALM-Chicago)

Northwestern University

Status: Begins enrollment this month

Conditions: Hypertension; Depression

Treatments: Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06987799

K23HL168234 (U.S. NIH Grant/Contract)

STU00215977

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Culturally adapted mindfulness-based stress reduction intervention

Experimental group

Description:

This arm will participate in the CALM-Chicago intervention, a culturally adapted mindfulness-based stress reduction intervention that has been further adapted for implementation in faith-based communities on the South Side of Chicago. The intervention includes 8 weekly group sessions in which participants receive education about mindfulness, stress reduction, and blood pressure management; practice mindfulness activities and meditation; and develop a personal mindfulness practice.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)