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

Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science

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)

Study Overview

• Status: Recruiting
• Conditions: Depression; Hypertension
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asia Ellis, BA; Phone Number: 13125033569; Email: asia.ellis@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Recruiting
      • The Salvation Army Ray and Joan Kroc Corps Community Center Chicago
      • Contact: Larissa Reed, MA; Email: lreedtrcdo@gmail.com
      • Contact: Asia Ellis, BA; Phone Number: 312-503-2781; Email: calmchicagostudy@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Culturally adapted mindfulness-based stress reduction intervention; 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.

Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study); This clinical trial will evaluate the effectiveness of the culturally adapted intervention, CALM-Chicago, in a community setting. CALM-Chicago has been previously used in a clinical setting.; Other Names: CALM-Chicago; M-Body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Depressive Symptom Response	Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, and change in appetite. As a clinically sensitive measures of depressive symptom response, participants will complete the Centers for Epidemiologic Studies Depression Scale (CES-D). The CES-D consists of twenty items rated on a four-point Likert scale from 1 (Rarely or None of the time) to 4 (Most or All of the time). Total scores range from 0 to 60, with higher scores indicating a greater burden of depressive symptoms. The CES-D is often used in clinical trials and will be used as a measure of effect of the intervention as change in depressive symptoms and has been validated in diverse populations.	From enrollment to the end of treatment at 8 weeks
Effectiveness: Systolic Blood Pressure Response	Blood pressure (BP) will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged. A clinically meaningful change in systolic BP, as defined as a decrease of ≥5 mmHg, would be indicative of a clinical effect of the intervention.	From enrollment to the end of treatment at 8 weeks
Implementation: Acceptability	One of the primary implementation outcomes will be acceptability of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Acceptability will be measured using the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). AIM scores range from 4 to 20, with higher scores indicating greater acceptability.	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Implementation: Appropriateness	One of the primary implementation outcomes will be appropriateness of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Appropriateness will be measured using the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). IAM scores range from 4 to 20, with higher scores indicating greater appropriateness.	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Implementation: Feasibility	One of the primary implementation outcomes will be feasibility of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Feasibility will be measured using the Feasibility of Intervention Measure (FIM). The FIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). FIM scores range from 4 to 20, with higher scores indicating greater feasibility.	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Depressive Symptom Remission	Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, or change in appetite. As a measure of depression that is commonly used in medical care, participants will complete the Patient Health Questionnaire 9-item scale (PHQ-9). The PHQ-9 consists of 9 items that are rated on a four-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Total scores range from 0 to 27, where higher score indicate greater burden of depressive symptoms. Scores ≥10 on the PHQ-9 are suggestive of a depressive episode. The PHQ-9 is consistent with measurement of depressive symptoms in medical/clinical settings and will serve as a clinically meaningful indicator of improvement in depressive symptoms (50% decrease in PHQ-9 score and/or PHQ-9 score <10).	From enrollment to the end of treatment at 8 weeks
Effectiveness: Blood Pressure Control	Blood pressure control is defined as maintaining blood pressure within a healthy range (i.e., <120/<80 mmHg for healthy adults; <130/<80 mmHg for adults with hypertension). Blood pressure will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged. Blood pressure control (clinically meaningful indicator) will be defined as <130/<80 mmHg, per American Heart Association guidelines of blood pressure control among individuals diagnosed with hypertension.	From enrollment to the end of treatment at 8 weeks
Effectiveness: Medication Adherence	Medication adherence is defined as whether a person takes a medication as prescribed (e.g., twice daily). Medication adherence will be measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale. The Hill-Bone Compliance Scale is a 14-item scale with each item scored using a 4-point Likert scale ranging from 1 (All of the time) to 4 (None of the time). One item is reverse coded. Total scores range from 14 to 56, where higher scores indicate poorer medication adherence.	From enrollment to the end of treatment at 8 weeks
Implementation: Fidelity	Fidelity will be assessed by how well the interventionists, community members, organizational leaders, and researchers adhere to the intervention and implementation protocols. Specifically fidelity to the intervention protocol will be measured using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Ratings will be completed by the group leaders (self-ratings) and by trained research team members. The MBI:TAC summary sheet evaluates instructor competency across 6 domains, each comprising 3 to 5 key features. Items are scored using a 6-point Likert scale ranging from 1 (Incompetent) to 6 (Advanced). Total scores range from 27 to 162, with higher scores indicating greater competency in delivering the intervention and, therefore, greater intervention fidelity.	Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Total Resource Community Development Organization (TRCDO)
• Investigators: Principal Investigator: Allison J Carroll, PhD, Northwestern University

Publications and helpful links

General Publications

• Burnett-Zeigler I, Zhou E, Martinez JH, Zumpf K, Lartey L, Moskowitz JT, Wisner KL, McDade T, Brown CH, Gollan J, Ciolino JD, Schauer JM, Petito LC. Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC). Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 15, 2025
• First Posted (Actual): May 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: depression; hypertension; high blood pressure; african american; culturally adapted
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Hypertension; Depression; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: STU00215977; K23HL168234 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All datasets that can be shared will be deposited in openICPSR, a repository for social, behavioral, and health sciences research data. The participant dataset will include self-reported demographics, psychological metrics, clinical data. The community partners dataset will include coded qualitative responses. The investigators will share de-identified individual-participant level (IPD) data. Item-level data will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. Appropriate measures such as removing or recoding identifiers (per Section 164.514(a) of the HIPAA Privacy Rule) will be used for data de-identification and sharing. To facilitate interpretation of the data, data dictionaries, statistical analysis plans, and data collection instruments will be shared and associated with the relevant datasets.
• IPD Sharing Time Frame: The IPD will be available with the publication of the primary study outcomes.
• IPD Sharing Access Criteria: All datasets that can be shared will be deposited in openICPSR, a repository for social, behavioral, and health sciences research data. The participant dataset will include self-reported demographics, psychological metrics, clinical data. The community partners dataset will include coded qualitative responses. The investigators will share de-identified individual-participant level (IPD) data. Item-level data will be shared openly, along with example quantifications and transformations from initial raw data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No