Mindfulness for Hypertension and Depression

(CALM-Chicago Trial)

Overseen By Asia Ellis, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Antidepressants

Disqualifiers: Severe mental illness, suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Research Team

Allison J Carroll, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for African American adults who have both high blood pressure and depression. Participants will engage in an 8-week group-based mindfulness program designed to manage stress and improve health outcomes, specifically tailored to their cultural needs.

Inclusion Criteria

Lives, works, or spends much of their time in the South Side of Chicago neighborhood

I have been diagnosed with high blood pressure by a doctor.

Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10

Exclusion Criteria

I am under 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week group-based mindfulness intervention (CALM-Chicago) focusing on mindfulness and stress management.

8 weeks

8 weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of depressive symptoms and blood pressure control.

up to 3 years

Treatment Details

Interventions

• Mindfulness-Based Stress Reduction (MBSR)

Trial Overview The study tests a culturally adapted Mindfulness-Based Stress Reduction (MBSR) program called CALM-Chicago. It aims to see if this intervention can reduce depressive symptoms and help control blood pressure when delivered in a community setting.

Participant Groups

Group I: Culturally adapted mindfulness-based stress reduction intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Total Resource Community Development Organization (TRCDO)

Collaborator