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

Trial Summary

What is the purpose of this trial?

The Women's HARP study is a multi-center study focusing on women with clinical presentation of myocardial infarction (MI). Women will complete stress questionnaires following presentation to the medical center with elevated cardiac enzymes and abnormal electrocardiograms (ECGs). 2 months following MI, participants will be screened for the Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported. After completing baseline assessments, participants will be randomized to Enhanced Usual Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.

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.

What data supports the effectiveness of the treatment Enhanced Usual Care, Duphalac, Kristalose, Stress Management, Stress Reduction, Anxiety Management, Prenatal Stress Intervention for heart attack patients?

Research shows that stress management programs can significantly reduce anxiety and depression in heart attack patients, improving their overall quality of life and social activities. Additionally, regular contact and support from healthcare providers can lead to significant reductions in mortality for patients with coronary heart disease. ^{1 2 3 4 5}

Is the stress management treatment safe for humans?

The research articles provided do not contain specific safety data for stress management treatments or related interventions like Enhanced Usual Care, Duphalac, Kristalose, or Anxiety Management. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the Stress Management treatment for heart attack differ from other treatments?

This Stress Management treatment is unique because it combines stress reduction techniques with enhanced usual care, focusing on both the patient and their family to reduce stress and improve quality of life after a heart attack. It emphasizes relaxation, self-confidence, and control, which can lead to reduced anxiety and depression, and improved social and daily activities. ^{1 2 3 4 11}

Research Team

Harmony R Reynolds, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

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

You have thoughts of hurting yourself.

Current participation in another behavioral clinical trial

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stress management in cardiac patients: a preliminary study of the predictors of improvement in quality of life. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Brief strategic therapy in first myocardial infarction patients with increased levels of stress: a randomized clinical trial. [2015]

3. Canada pubmed.ncbi.nlm.nih.gov

Comforting the after-coronary patient. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Family stress management following acute myocardial infarction: an educational and skills training intervention program. [2019]

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

Effects of a psychological intervention programme on mental stress, coping style and immune function in percutaneous coronary intervention patients. [2023]

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

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

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

Spontaneous adverse event reports of serious ventricular arrhythmias, QT prolongation, syncope, and sudden death in patients treated with cisapride. [2017]

8. Brazil pubmed.ncbi.nlm.nih.gov

Proposal of a trigger tool to assess adverse events in dental care. [2019]

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

Contraindicated use of cisapride: impact of food and drug administration regulatory action. [2019]

10. Germany 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. [2023]

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

Comparison of psychologic stress responses in patients and spouses ten weeks after a cardiac illness event. [2007]