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

Trial Summary

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 data supports the effectiveness of the treatment Mindfulness App Training for Heart Disease?

Research shows that online mindfulness training can lead to small improvements in exercise capacity, blood pressure, mental functioning, and depression in heart disease patients, suggesting it could be a helpful addition to usual care. ^{1 2 3 4 5}

Is mindfulness training safe for humans?

Mindfulness training is generally considered safe for humans and is often used to improve psychological well-being and quality of life. It has been integrated into healthcare for self-care and disease management, with studies supporting its use in various conditions. ^{3 4 5 6 7}

How does the Mindfulness App Training for Heart Disease treatment differ from other treatments?

This treatment is unique because it uses mindfulness training, which can help reduce stress and improve emotional regulation, potentially leading to better exercise capacity and mental health in heart disease patients. Unlike traditional treatments that focus on medication, this approach emphasizes self-care and stress management through mindfulness practices. ^{1 2 3 4 5}

What is the purpose of this trial?

This study will investigate the feasibility and effects of a smartphone-based mindfulness training program vs. usual care in a sample of stressed midlife and older adults at risk for cardiovascular disease. 105 participants will be randomly assigned to complete a four-week mindfulness training intervention, which involves 28 audio-guided lessons and practice prompts delivered 3x daily, or to continue with their regular routines. Data will be collected at baseline, post-intervention, and three-month follow-up. The study will involve seven laboratory visits, which will include assessments and training on daily life monitoring and intervention procedures. Data assessing subjective and physiological stress reactivity in daily life will be collected for 3 days at pre-intervention, post-intervention, and 3-month follow-up. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop models that predict daily life stress. Data will be used to evaluate feasibility of the intervention and assessments in a sample at risk for cardiovascular disease and to test effects of mindfulness training on subjective and physiological stress reactivity.

Research Team

Thomas W Kamarck, PhD

Principal Investigator

University of Pittsburgh

Emily K Lindsay, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

I am 45 years old or older.

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

High perceived stress (above 15 on the 10-item Perceived Stress Scale)

Exclusion Criteria

Pregnancy

Positive PTSD screen (traumatic event(s) endorsed and total score ≥3 on Primary Care PTSD screen for DSM-5)

Typical alcohol consumption ≥15 drinks per week

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. [2018]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness and physical disease: a concise review. [2020]

5. United States 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. [2023]

6. Scotland 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. [2023]

7. United States 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. [2021]