Community-based Approach to Lowering Stress Through Mindfulness

NCT06987799 | Recruiting

• 2 other identifiers: STU00215977K23HL168234
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Depression; Hypertension

Keywords

culturally adapted; african american; depression; high blood pressure; hypertension

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Effectiveness: Depressive Symptom Remission

  From enrollment to the end of treatment at 8 weeks

• Effectiveness: Blood Pressure Control

  From enrollment to the end of treatment at 8 weeks

• Effectiveness: Medication Adherence

  From enrollment to the end of treatment at 8 weeks

• Implementation: Fidelity

  Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years

Study Arms (1)

Culturally adapted mindfulness-based stress reduction intervention

EXPERIMENTAL

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)

Interventions

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

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.

Also known as: CALM-Chicago, M-Body

Culturally adapted mindfulness-based stress reduction intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Total Resource Community Development Organization (TRCDO): collaborator

Study Sites (1)

The Salvation Army Ray and Joan Kroc Corps Community Center Chicago

Chicago, Illinois, 60643, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36803835 BACKGROUND

MeSH Terms

Conditions

Depression; Hypertension

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Allison J Carroll, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asia Ellis, BA

CONTACT

13125033569; asia.ellis@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 23, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be available with the publication of the primary study outcomes.
• 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.

Locations

US (1)