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Recruiting NCT06987799

Community-based Approach to Lowering Stress Through Mindfulness

No phase Interventional Depression Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study).
Who it may be relevant to
Registry conditions: Depression, Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science

Overview

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)

Interventions

  • Behavioral 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 measures

  • 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]
Secondary outcome measures (4)
  • Effectiveness: Depressive Symptom Remission [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Effectiveness: Blood Pressure Control [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Effectiveness: Medication Adherence [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Implementation: Fidelity [Time frame: Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Salvation Army Ray and Joan Kroc Corps Community Center Chicago — Chicago

Publications

  • 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- PMID 36803835

Identifiers

NCT: NCT06987799 · STU00215977 · K23HL168234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗