Community-based Approach to Lowering Stress Through Mindfulness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2028-05-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Depression Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CALM-Chicago M-Body

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No