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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
Must not have
History of or current diagnosis of psychosis (EHR review)
Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history or current diagnosis of psychosis.
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I have severe depression symptoms.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perceived Stress Scale (PSS-10) scores
Secondary study objectives
Patient Health Questionnaire (PHQ-9)
Seattle Angina Questionnaire-7 Score (SAQ-7)
Short Form (SF-12) Score
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Enhanced Usual Care
2019
Completed Phase 3
~8490
Actigraph
2005
Completed Phase 1
~1520
Stress Management
2011
N/A
~3230

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
855,877 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
~31 spots leftby Jun 2026
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