Mindfulness for Hypertension and Depression

(CALM-Chicago Trial)

Overseen By Asia Ellis, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Antidepressants

Disqualifiers: Severe mental illness, suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mindfulness program can help African American adults with both high blood pressure (hypertension) and depression. The program, Mindfulness-Based Stress Reduction (MBSR), teaches mindfulness and stress reduction techniques, such as meditation and deep breathing, over eight weeks in a community setting. Researchers aim to determine if this approach can improve mood and blood pressure levels, and if participants find it helpful and easy to follow. The trial seeks participants who live or spend time on the South Side of Chicago, have been diagnosed with high blood pressure, and experience symptoms of depression. As an unphased trial, this study offers a unique opportunity to explore new ways to manage health conditions through mindfulness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on antidepressant medication, you must have been stable on it for at least 6 months to participate.

What prior data suggests that this mindfulness-based intervention is safe for participants?

Research has shown that Mindfulness-Based Stress Reduction (MBSR) is generally safe for most people. Studies have found that MBSR can help lower blood pressure in individuals with hypertension, and participants have reported improved mental well-being.

Safety checks in similar programs have not identified major concerns. While any treatment can have side effects, serious ones are rare with MBSR. Monthly safety checks monitor for unexpected issues, and any problems are recorded, though no significant reports of harm have emerged.

Overall, MBSR is well-tolerated and considered safe for individuals with high blood pressure and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-based stress reduction (MBSR) is unique because it offers a holistic approach by integrating mindfulness and stress management techniques specifically adapted for culturally diverse communities. Unlike standard treatments for hypertension and depression, which often rely on medication like antihypertensives and antidepressants, MBSR focuses on mental and emotional wellness through mindfulness practices. Researchers are excited about this method because it empowers individuals to manage their stress and blood pressure naturally, potentially reducing the need for medication and personalizing care based on cultural and community needs.

What evidence suggests that this mindfulness-based intervention is effective for hypertension and depression?

Research has shown that mindfulness-based stress reduction (MBSR) can improve blood pressure and mental health. In one study, a 12-week MBSR program significantly lowered both systolic and diastolic blood pressure and improved mental health. Another review found that an 8-week MBSR program reduced blood pressure in individuals with high levels. Additionally, studies indicate that MBSR helps lower blood pressure and ease depression and anxiety, particularly in low-income, African-American older adults. This trial will involve a culturally adapted mindfulness-based stress reduction intervention, incorporating mindfulness meditation, a key component of MBSR known for reducing stress, depression, and blood pressure. ^{1 3 6 7 8}

Who Is on the Research Team?

Allison J Carroll, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for African American adults who have both high blood pressure and depression. Participants will engage in an 8-week group-based mindfulness program designed to manage stress and improve health outcomes, specifically tailored to their cultural needs.

Inclusion Criteria

Lives, works, or spends much of their time in the South Side of Chicago neighborhood

I have been diagnosed with high blood pressure by a doctor.

Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10

Exclusion Criteria

I am under 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week group-based mindfulness intervention (CALM-Chicago) focusing on mindfulness and stress management.

8 weeks

8 weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of depressive symptoms and blood pressure control.

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Based Stress Reduction (MBSR)

Trial Overview The study tests a culturally adapted Mindfulness-Based Stress Reduction (MBSR) program called CALM-Chicago. It aims to see if this intervention can reduce depressive symptoms and help control blood pressure when delivered in a community setting.

How Is the Trial Designed?

Group I: Culturally adapted mindfulness-based stress reduction intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Total Resource Community Development Organization (TRCDO)

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222936/

Effects of Mindfulness-Based Stress Reduction on Blood ... The 12-week MBSR program resulted in a significant reduction in the mean systolic and diastolic blood pressures and improvement in mental health and different ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16160

Effect and Acceptability of Mindfulness-Based Stress ... The current meta-analysis provided evidence that a standard 8-week MBSR program can reduce office SBP/DBP in patients with an elevated BP and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022399914000543

Effectiveness of mindfulness-based stress reduction and ... Indeed, randomised controlled studies of MBSR intervention have been shown to reduce blood pressure in low-income African-American older adults [16], and in ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08139-0

Mindfulness-based intervention for hypertension patients with ... Mindfulness-based, short-term focused interventions provide modest relief for depression and/or anxiety and are effective in lowering blood pressure and ...

5. medrxiv.org medrxiv.org/content/10.1101/2021.08.18.21262240.full

Effects of the Mindfulness-Based Blood Pressure ... Mindfulness meditation is particularly effective at attenuating stress, depression, and blood pressure (Ponte Márquez et al.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33131316/

A Meta-Analysis of Randomized Controlled Trials The mindfulness-based stress reduction program (MBSR) may reduce blood pressure (BP) in patients with hypertension or elevated BP.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722005730

Effects of the Mindfulness-Based Blood Pressure ... It is concluded that MB-BP induces alterations in brain structural connectivity which could mediate beneficial changes in depression and interoceptive ...

8. medrxiv.org medrxiv.org/content/10.1101/2025.05.27.25328464v1.full-text

Impact of the Mindfulness-Based Blood Pressure ... Monthly online safety checks monitor serious adverse events and physical injuries. Any adverse events were recorded by the data safety ...