Recruiting

CALM-ChicagoCommunity-based Approach to Lowering Stress Through Mindfulness

Sponsor:

Northwestern University

Code:

NCT06987799

Conditions

Depression

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06987799

Start date

Sep 10, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

Effectiveness: Depressive Symptom Response [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
Effectiveness: Systolic Blood Pressure Response [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
Implementation: Acceptability [ Time Frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years ]
Implementation: Appropriateness [ Time Frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years ]
Implementation: Feasibility [ Time Frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years ]

Central Contacts and Locations

Central contacts

Asia Ellis, BA

13125033569 asia.ellis@northwestern.edu

Locations

The Salvation Army Ray and Joan Kroc Corps Community Center Chicago

Recruiting

Chicago, Illinois, United States, 60643

Contacts

Asia Ellis, BA

312-503-2781 calmchicagostudy@northwestern.edu

Larissa Reed, MA

lreedtrcdo@gmail.com

More Information

Sponsor

Northwestern University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

culturally adapted
african american
depression
high blood pressure
hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-13.