Clinical trial NCT06987799: Community-based Approach to Lowering Stress Through Mindfulness
Official title: Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Hypertension
Keywords: culturally adapted
african american
depression
high blood pressure
hypertension
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Total Resource Community Development Organization (TRCDO)
First posted: 2025-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness: Depressive Symptom Response
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Effectiveness: Systolic Blood Pressure Response
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Implementation: Acceptability
timeFrame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
measure: Implementation: Appropriateness
timeFrame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
measure: Implementation: Feasibility
timeFrame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Secondary outcomes:
measure: Effectiveness: Depressive Symptom Remission
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Effectiveness: Blood Pressure Control
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Effectiveness: Medication Adherence
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Implementation: Fidelity
timeFrame: Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Triedstone Church of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Allison J Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.