CALM-Chicago Study for Depression and High Blood Pressure
This study is testing a program called CALM-Chicago, which uses mindfulness (a way to focus on the present moment) to help African American adults in the South Side of Chicago who have both high blood pressure (hypertension) and depression. Researchers want to see if CALM-Chicago can improve depressive symptoms and help control blood pressure. They also want to understand if this program is well-received and practical to offer in a community setting. The study is looking for about 60 participants who are 18 or older, live or work in the South Side of Chicago, have a diagnosis of high blood pressure, and show signs of elevated depressive symptoms. The study is currently recruiting participants.
- Study design
- This interventional study plans to enroll 60 participants. It is testing a behavioral intervention called Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study).
- What's involved
- You would participate in an 8-week group-based mindfulness intervention called CALM-Chicago. Your depressive symptoms and blood pressure will be measured from enrollment to the end of treatment at 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your acceptability of the intervention will be assessed every 6 weeks during enrollment and follow-up for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Community-based Approach to Lowering Stress Through Mindfulness
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Allison J Carroll, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Effectiveness: Depressive Symptom ResponseFrom 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 ResponseFrom 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: AcceptabilityAssessed 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: AppropriatenessAssessed 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: FeasibilityAssessed 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.