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Stress Management for Heart Attack (HARP Trial)

N/A

Waitlist Available

Led By Harmony R Reynolds, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female sex

Objective evidence of MI (either or both of the following): Elevation of troponin to above the laboratory upper limit of normal, ST segment elevation of ≥1mm on 2 contiguous ECG leads

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

HARP Trial Summary

This trial is studying stress management in women who have had a heart attack. Women will fill out stress questionnaires and may be enrolled in the study if they report high levels of stress. They will be randomly assigned to either a stress management program or usual care, and followed for 6 months.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like stress management techniques, side effects may include discomfort from discussing personal experiences or wearing the Actigraph device but no medical side effects are expected.

HARP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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

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I have had symptoms like chest pain that suggest a heart attack.

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I am 21 years old or older.

HARP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived Stress Scale (PSS-10) scores

Secondary outcome measures

Patient Health Questionnaire (PHQ-9)

Seattle Angina Questionnaire-7 Score (SAQ-7)

Short Form (SF-12) Score

+1 more

HARP Trial Design

2Treatment groups

Experimental Treatment

Group I: Stress ManagementExperimental Treatment2 Interventions

Group II: Enhanced Usual Care (EUC)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stress Management

2011

N/A

~2820

Actigraph

2005

N/A

~1440

Enhanced Usual Care

2019

Completed Phase 3

~8530

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,526 Total Patients Enrolled

Harmony R Reynolds, MDPrincipal InvestigatorNYU Langone Medical Center

2 Previous Clinical Trials

800 Total Patients Enrolled

Media Library

Enhanced Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT02914483 — N/A

Heart Attack Research Study Groups: Stress Management, Enhanced Usual Care (EUC)

Heart Attack Clinical Trial 2023: Enhanced Usual Care Highlights & Side Effects. Trial Name: NCT02914483 — N/A

Enhanced Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT02914483 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity for enrolment in this research?

"At this time, the clinical trial posted on August 1st 2016 is not soliciting any participants. The last update occured on July 18th 2022. Although it has stopped enrolling candidates, there are many other studies that are still welcoming new patients as of now."

Answered by AI

Can elderly individuals over 80 participate in this experiment?

"In order to be accepted for the clinical trial, applicants must between 21 and 99 years old. There are 11 peculiar studies targeting those younger than 18 while there are 357 trials dedicated to seniors aged 65 or over."

Answered by AI

To whom is this scientific exploration open?

"This clinical trial, which has a target of 200 participants, requires enrollees to have suffered from myocardial infarction and be between the ages 21 and 99."

Answered by AI

Are there any North American sites currently conducting this trial?

"Ohio State University Medical Center in Columbus, Ohio, Univeristy of Florida in Gainesville, Florida and Cedars-Sinai Medical Center in Los Angeles California are among the 15 trial locations."

Answered by AI

Recent research and studies

American Heart JournalJournal

Telephone-based Mindfulness Training to Reduce Stress in Women with Myocardial Infarction: Rationale and Design of a Multicenter Randomized Controlled Trial

Spruill, Tanya M., Harmony R. Reynolds, Victoria Vaughan Dickson, Amanda J. Shallcross, Pallavi D. Visvanathan, Chorong Park, Jolaade Kalinowski, et al.. 2018. “Telephone-based Mindfulness Training to Reduce Stress in Women with Myocardial Infarction: Rationale and Design of a Multicenter Randomized Controlled Trial”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2018.03.028.

clinicaltrials.govStudy

Women's Heart Attack Research Program: Stress Ancillary Study

2016. "Women's Heart Attack Research Program: Stress Ancillary Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02914483.

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