Mindfulness App Training for Heart Disease

(MATCH Trial)

Overseen By Emily K Lindsay, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Atherosclerotic disease, Night shifts, Pregnancy, Alcohol, Marijuana, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a mindfulness app can reduce stress in individuals at risk for heart disease. Participants will either use the app with guided meditation lessons (Mindfulness Training) or continue their usual care routine, receiving stress management resources (Enhanced Usual Care). The study will track stress levels using phone and sensor data to assess the app's effectiveness. Suitable candidates include those living in the Pittsburgh area with high stress, high blood pressure, and possibly diabetes or high cholesterol. As an unphased trial, this study provides a unique opportunity to explore innovative stress reduction methods that could enhance heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, as the study compares mindfulness training to regular routines.

What prior data suggests that this mindfulness training is safe for individuals at risk for cardiovascular disease?

Research shows that mindfulness training is generally safe for most people. Studies have found that mindfulness activities can help reduce stress and manage high blood pressure. For instance, one study showed that a mindfulness program effectively lowered stress levels in healthcare workers. Another study found that practicing mindfulness can help people feel more balanced and connected, which is important for overall well-being.

Participants in these studies did not report any major negative effects from mindfulness practices. This suggests that most people handle mindfulness training well. As always, individuals should consider their own health conditions and consult a healthcare provider before starting any new health program, but current evidence supports the safety of mindfulness training. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Training app because it offers a unique approach to managing heart disease by focusing on mental well-being through mindfulness. Unlike traditional treatments that often rely on medication or lifestyle changes, this app delivers 28 audio-guided lessons to teach meditation techniques like concentration, sensory clarity, and equanimity. The app also provides daily practice prompts to reinforce these skills. This method could provide a convenient, non-pharmacological tool to help individuals manage stress, which is a key factor in heart disease.

What evidence suggests that this mindfulness training might be an effective treatment for heart disease?

Research has shown that mindfulness training, which participants in this trial may receive, benefits heart health. A review of studies found that mindfulness-based activities help reduce anxiety and stress, both linked to heart disease. Another study found that these programs lower blood pressure and body mass index, both crucial for heart health. Guided meditations and mindfulness techniques have also been linked to better blood pressure control and improvements in heart health markers. These findings suggest that mindfulness training might help manage stress and improve overall heart health, which is vital for those at risk of heart disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Thomas W Kamarck, PhD

Principal Investigator

University of Pittsburgh

Emily K Lindsay, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults aged 45+ in the Pittsburgh area with hypertension and moderate-to-high cardiovascular risk are eligible. They must have a compatible smartphone, speak English well, and be available for study visits. Excluded are those with severe heart conditions, night shift workers, heavy drinkers or drug users, pregnant women, individuals with certain mental health issues or who practice mind-body exercises regularly.

Inclusion Criteria

Living in the Pittsburgh area for the next 5 months and available for study visits and activities during this period

I am 45 years old or older.

I have been diagnosed with high blood pressure.

Exclusion Criteria

Pregnancy

Typical alcohol consumption ≥15 drinks per week

Marijuana or hashish use >9 of the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a smartphone-based mindfulness training program or continue their regular routines for 4 weeks

4 weeks

7 laboratory visits for assessments and training

Post-Intervention Monitoring

Participants complete a second week of daily life monitoring, including assessments of stress reactivity and cardiovascular responses

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a third week of monitoring three months later

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Mindfulness Training

Trial Overview

The trial is testing if using a mindfulness app can help stressed adults at risk of heart disease. Half will use the app daily for four weeks; the other half won't change their routine. Stress levels will be measured before and after intervention and again three months later using lab visits and wearable devices.

How Is the Trial Designed?

Group I: Mindfulness Training Experimental Treatment 1 Intervention

Mindfulness intervention involving 28 audio-guided lessons plus daily brief practice prompts. Lessons train meditation techniques for 3 mindfulness skills: concentration, sensory clarity, and equanimity. Practice prompts delivered 3x daily build on the skills trained in each lesson.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Participants in the EUC condition will have no study requirements during the 4-week intervention period, but they will receive a list of stress management resources upon randomization (websites, books, health tracking apps, and mental health services) with no additional intervention support.

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Mindfulness training for primary care (MTPC) significantly improved emotion regulation in patients with anxiety, depression, and stress-related disorders, showing reductions in difficulties in emotion regulation scores at both 8 and 24 weeks compared to a low-dose mindfulness comparator.

MTPC also facilitated health behavior change, with 63% of participants successfully initiating their action plans within 3 weeks, compared to only 38% in the low-dose group, indicating its effectiveness in promoting self-management of chronic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. Gawande, R., Smith, L., Comeau, A., et al.[2023]

Mindfulness training (MT) delivered via phone was found to be feasible and well-accepted by participants, with a 100% retention rate and 91% attendance over 8 weeks among 33 outpatients with heart failure.

While MT did not improve medication adherence or depression levels, it significantly enhanced cognitive function, functional capacity, and mindfulness skills, indicating potential benefits for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. Salmoirago-Blotcher, E., Walaska, K., Trivedi, D., et al.[2023]

A brief mindfulness-based stress reduction program significantly improved nursing students' attitudes towards medical errors and reduced the number of medical errors made in a simulation environment, based on a study of 78 third-year nursing students.

While the program enhanced awareness of medical errors, it did not significantly affect self-confidence or satisfaction levels among the students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a brief mindfulness-based stress reduction program on strengthening awareness of medical errors and risks among nursing students. Tarhan, M., Elibol, E.[2023]

A 12-month follow-up study involving 324 patients with heart disease showed that online mindfulness training led to a small but significant improvement in exercise capacity, with participants walking an average of 17.9 meters further in a 6-minute test compared to usual care.

Mindfulness training also resulted in favorable long-term effects on systolic blood pressure, mental functioning, and depressive symptoms, suggesting it could be a beneficial addition to standard clinical care for heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial. Gotink, RA., Younge, JO., Wery, MF., et al.[2019]

Higher levels of trait mindfulness and mindfulness training are linked to improved psychological well-being and quality of life, suggesting potential benefits for managing stress-related diseases.

While many studies support the integration of mindfulness into healthcare for self-care and disease management, more rigorous research with larger trials and objective measures is needed to confirm its effects on physical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and physical disease: a concise review. Greeson, JM., Chin, GR.[2020]

In a study involving 324 patients with heart disease, 12 weeks of online mindfulness training resulted in a borderline significant improvement in exercise capacity, as measured by the 6-minute walk test, compared to usual care alone.

Mindfulness training also significantly reduced heart rate in patients, suggesting it may be a beneficial addition to standard treatments for improving physiological health in heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. Younge, JO., Wery, MF., Gotink, RA., et al.[2018]

A brief mindfulness-based stress reduction intervention significantly improved psychological and social quality of life in cardiac patients after a percutaneous coronary intervention (PCI), compared to a self-help control group, with 114 participants involved in the study.

The intervention was particularly effective in reducing anxiety and depression symptoms in patients younger than 60 years, suggesting that mindfulness training may be more beneficial for younger cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief mindfulness based intervention for increase in emotional well-being and quality of life in percutaneous coronary intervention (PCI) patients: the MindfulHeart randomized controlled trial. Nyklíček, I., Dijksman, SC., Lenders, PJ., et al.[2021]

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