Women's Heart Attack Research Program: Stress Ancillary Study (HARP)

NYU Langone Health

Status

Active, not recruiting

Conditions

Myocardial Infarction

Treatments

Behavioral: Stress Management

Diagnostic Test: Actigraph

Behavioral: Enhanced Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02914483

16-01104-1

Details and patient eligibility

About

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.

Full description

Women's HARP is a multi-center, observational study which enrolls women with MI who are referred for cardiac catheterization. During the MI hospitalization, questionnaires will be administered to assess psychosocial stress leading up to the event (MI). Participants will also have the option to enroll in the HARP-Stress Ancillary Study and HARP-Platelet Sub-Study. Two months following MI, participants may be screened for the Stress Ancillary Study. Women with elevated perceived stress at screening will be enrolled. Patients will complete baseline assessments (self-report questionnaires and 7 days of wrist actigraphy) and then will be randomized to group-based stress management or to enhanced usual care (EUC). Both study arms involve 8 weekly phone sessions delivered by trained facilitators. Following intervention, participants in both study arms will repeat self-report questionnaires and 7 days of wrist actigraphy. Anticipate enrollment of approximately 200 women to meet target of 144 qualified women.

Enrollment

200 estimated patients

Sex

Female

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
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
Willing to provide informed consent and comply with all aspects of the protocol
Age ≥ 21 years
Female sex
PSS-4 score ≥6 at 2 month follow up visit after MI

Exclusion criteria

Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma.
Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening)
History of or current diagnosis of psychosis (EHR review)
Significant cognitive impairment (EHR review or evident during screening)
Current participation in another behavioral clinical trial.