Women's Heart Attack Research Program: Stress Ancillary Study

Not Applicable

Active, not recruiting

Interventions: Behavioral: Enhanced Usual Care
Behavioral: Stress Management
Diagnostic Test: Actigraph

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10) scores	6 months	6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	6 months	6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Short Form (SF-12) Score	6 months	6-month change in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12)
Sleep quality	6 months	6-month change in sleep efficiency as measured by wrist actigraphy
Seattle Angina Questionnaire-7 Score (SAQ-7)	6 months	6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7)

Locations (14): Johns Hopkins Medical Center
🇺🇸
Baltimore, Maryland, United States
University of Calgary
🇨🇦
Calgary, Canada
University of Alberta
🇨🇦
Edmonton, Alberta, Canada
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Univeristy of Florida
🇺🇸
Gainesville, Florida, United States
Dartmouth-Hitchcock
🇺🇸
Lebanon, New Hampshire, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
NYU Winthrop
🇺🇸
Mineola, New York, United States
St. Luke's University Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
Seton Heart (Ascension) - University of Texas, Austin
🇺🇸
Austin, Texas, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States