Community-based Approach to Lowering Stress Through Mindfulness

Not Applicable

Not yet recruiting

• Conditions: Depression; Hypertension

• Registration Number: NCT06987799
• Lead Sponsor: Northwestern University

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-15
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness: Depressive Symptom Response	From enrollment to the end of treatment at 8 weeks	Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, and change in appetite. As a clinically sensitive measures of depressive symptom response, participants will complete the Centers for Epidemiologic Studies Depression Scale (CES-D). The CES-D consists of twenty items rated on a four-point Likert scale from 1 (Rarely or None of the time) to 4 (Most or All of the time). Total scores range from 0 to 60, with higher scores indicating a greater burden of depressive symptoms.; The CES-D is often used in clinical trials and will be used as a measure of effect of the intervention as change in depressive symptoms and has been validated in diverse populations.
Effectiveness: Systolic Blood Pressure Response	From enrollment to the end of treatment at 8 weeks	Blood pressure (BP) will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged. A clinically meaningful change in systolic BP, as defined as a decrease of ≥5 mmHg, would be indicative of a clinical effect of the intervention.
Implementation: Acceptability	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years	One of the primary implementation outcomes will be acceptability of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Acceptability will be measured using the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). AIM scores range from 4 to 20, with higher scores indicating greater acceptability.
Implementation: Appropriateness	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years	One of the primary implementation outcomes will be appropriateness of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Appropriateness will be measured using the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). IAM scores range from 4 to 20, with higher scores indicating greater appropriateness.
Implementation: Feasibility	Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years	One of the primary implementation outcomes will be feasibility of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Feasibility will be measured using the Feasibility of Intervention Measure (FIM). The FIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). FIM scores range from 4 to 20, with higher scores indicating greater feasibility.

Secondary Outcome Measures

Name	Time	Method
Effectiveness: Depressive Symptom Remission	From enrollment to the end of treatment at 8 weeks	Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, or change in appetite. As a measure of depression that is commonly used in medical care, participants will complete the Patient Health Questionnaire 9-item scale (PHQ-9). The PHQ-9 consists of 9 items that are rated on a four-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Total scores range from 0 to 27, where higher score indicate greater burden of depressive symptoms. Scores ≥10 on the PHQ-9 are suggestive of a depressive episode.; The PHQ-9 is consistent with measurement of depressive symptoms in medical/clinical settings and will serve as a clinically meaningful indicator of improvement in depressive symptoms (50% decrease in PHQ-9 score and/or PHQ-9 score \<10).
Effectiveness: Blood Pressure Control	From enrollment to the end of treatment at 8 weeks	Blood pressure control is defined as maintaining blood pressure within a healthy range (i.e., \<120/\<80 mmHg for healthy adults; \<130/\<80 mmHg for adults with hypertension). Blood pressure will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged.; Blood pressure control (clinically meaningful indicator) will be defined as \<130/\<80 mmHg, per American Heart Association guidelines of blood pressure control among individuals diagnosed with hypertension.
Effectiveness: Medication Adherence	From enrollment to the end of treatment at 8 weeks	Medication adherence is defined as whether a person takes a medication as prescribed (e.g., twice daily). Medication adherence will be measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale. The Hill-Bone Compliance Scale is a 14-item scale with each item scored using a 4-point Likert scale ranging from 1 (All of the time) to 4 (None of the time). One item is reverse coded. Total scores range from 14 to 56, where higher scores indicate poorer medication adherence.
Implementation: Fidelity	Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years	Fidelity will be assessed by how well the interventionists, community members, organizational leaders, and researchers adhere to the intervention and implementation protocols. Specifically fidelity to the intervention protocol will be measured using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Ratings will be completed by the group leaders (self-ratings) and by trained research team members. The MBI:TAC summary sheet evaluates instructor competency across 6 domains, each comprising 3 to 5 key features. Items are scored using a 6-point Likert scale ranging from 1 (Incompetent) to 6 (Advanced). Total scores range from 27 to 162, with higher scores indicating greater competency in delivering the intervention and, therefore, greater intervention fidelity.

Trial Locations

Locations (1)

Triedstone Church of Chicago; 🇺🇸 Chicago, Illinois, United States