Stress Management for Heart Attack

(HARP Trial)

Recruiting at 13 trial locations

Overseen By Harmony R Reynolds, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Depression, Suicidal ideation, Psychosis, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women who have had a heart attack and are experiencing high stress levels. Researchers seek to determine if stress management techniques can improve recovery compared to usual care. Participants will be divided into two groups: one receiving stress management and the other receiving standard care, known as Enhanced Usual Care, which includes treatments like Duphalac and Kristalose. Women who have experienced a heart attack with symptoms such as chest pain and report high stress two months afterward are well-suited for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery strategies for women experiencing stress after a heart attack.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stress management techniques are generally safe for people recovering from a heart attack. Studies indicate that mental health treatments, such as those for anxiety or depression, can aid recovery in heart patients. For example, one study found that mindfulness-based stress reduction (MBSR) enhanced well-being in heart patients. These treatments are usually well-tolerated, with few serious side effects.

While not every method works the same for everyone, reducing stress is a positive step. The goal is to support mental health, which can aid heart healing. For those considering joining a study, it is reassuring to know that stress management has a history of being safe and helpful for many heart patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stress management as a treatment for heart attack recovery because it offers a non-pharmaceutical approach, focusing on reducing stress through techniques like meditation, counseling, and relaxation exercises. Unlike standard treatments that often rely on medication to manage symptoms and prevent further heart issues, stress management directly targets the emotional and psychological stressors that can impact heart health. This approach is unique because it empowers patients to take an active role in their recovery, potentially improving overall well-being and reducing the risk of future heart problems without additional medications. By addressing the root causes of stress, this method could complement existing care and offer a holistic path to recovery.

What evidence suggests that this trial's treatments could be effective for stress management in women after a heart attack?

Research has shown that managing stress can aid recovery after a heart attack. In this trial, participants will join either a Stress Management program or Enhanced Usual Care (EUC). One study found that incorporating stress management into cardiac rehabilitation (a program to improve heart health after an attack) reduced stress more effectively than usual care. Another study suggested that stress management might slightly lower the risk of dying from heart-related issues. Although some results vary, stress management has the potential to positively impact heart health following a heart attack. ^{2 6 7 8 9}

Who Is on the Research Team?

Harmony R Reynolds, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for women over 21 who've had a heart attack, shown by chest pain or similar symptoms and abnormal heart tests. They must be willing to follow the study rules and have felt stressed after their heart attack. Women with severe depression, suicidal thoughts, cognitive issues, other serious health problems explaining their symptoms, or in another behavior study can't join.

Inclusion Criteria

I am female.

I have had a heart attack confirmed by blood tests or an ECG.

Willing to provide informed consent and comply with all aspects of the protocol

Exclusion Criteria

Current participation in another behavioral clinical trial

You have thoughts of hurting yourself.

My high troponin levels are due to another health issue, not a heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months post-MI

Baseline Assessment

Participants complete self-report questionnaires and 7 days of wrist actigraphy

1 week

Treatment

Participants are randomized to Enhanced Usual Care (EUC) or stress management, involving 8 weekly phone sessions

8 weeks

8 phone sessions

Follow-up

Participants are monitored for changes in stress, health status, sleep quality, and depressive symptoms

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Stress Management

Trial Overview The study compares two ways of helping women after a heart attack: Enhanced Usual Care (EUC) versus stress management programs for 8 weeks. Participants are chosen randomly for either group and will answer questionnaires about stress and wear an Actigraph device to measure activity levels.

How Is the Trial Designed?

Group I: Stress Management Experimental Treatment 2 Interventions

Group II: Enhanced Usual Care (EUC) Experimental Treatment 2 Interventions

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?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

In a 5-year study at a Finnish tertiary hospital, the Global Trigger Tool (GTT) identified 53 adverse drug events (ADEs) among 834 patient records, indicating a rate of 13 ADEs per 1000 patient-days and affecting 6% of patients.

The study found that as the number of medication-related triggers increased, so did the likelihood of experiencing an ADE, suggesting that the GTT medication module is useful for detecting potential risks, although modifications could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. Valkonen, V., Haatainen, K., Saano, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824555/

Enhancing Cardiac Rehabilitation With Stress ... CR enhanced by SMT produced significant reductions in stress and greater improvements in medical outcomes compared with standard CR.

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001381

Post–Myocardial Infarction Psychological Distress The data on whether treatment of postmyocardial psychological distress improves cardiac prognosis are mixed and of variable quality, and further ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290389/

Effect of mindfulness-based stress reduction in patients ... This study aimed to examine the effects of mindfulness-based stress reduction (MBSR) in patients with acute myocardial infarction (AMI) after primary ...

4. journals.lww.com journals.lww.com/ebp/fulltext/2024/04000/does_stress_management_improve_outcomes_in.14.aspx

Does stress management improve outcomes in patients ... Stress management interventions seem to modestly decrease coronary heart disease (CHD)-associated mortality.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2214782922000690

Reducing stress and anxiety in patients with myocardial ... Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9334337/

Reducing stress and anxiety in patients with myocardial ... The planned E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study (e-SMINC) aims ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587445/

Advancements in Myocardial Infarction Management These models use a combination of clinical variables, biomarker measurements, and imaging data to estimate the probability of adverse outcomes ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031117

Impact of Mental Health Treatment on Outcomes in Patients ... Mental health treatment for anxiety or depression has a significant impact on outcomes in patients with cardiovascular disease consisting of reduced ...

9. nature.com nature.com/articles/s41598-019-54932-2

Randomized Trial of Mindfulness-Based Stress Reduction ... This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of ...