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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care (EUC) | Other |
| |
| Stress Management | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Usual Care | Behavioral | Participants randomized into the EUC group will complete 8 weekly individual sessions by phone. Each weekly session consists of: brief check-in and review of AHA brochure- "Women, Heart Disease and Stroke". |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) scores | 6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form (SF-12) Score | 6-month change in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12) | 6 months |
| Seattle Angina Questionnaire-7 Score (SAQ-7) | 6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7) |
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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):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Harmony R Reynolds, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Univeristy of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29864732 | Derived | Spruill TM, Reynolds HR, Dickson VV, Shallcross AJ, Visvanathan PD, Park C, Kalinowski J, Zhong H, Berger JS, Hochman JS, Fishman GI, Ogedegbe G. Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial. Am Heart J. 2018 Aug;202:61-67. doi: 10.1016/j.ahj.2018.03.028. Epub 2018 Apr 21. |
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De-identified data will be shared after the end of the study.
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|
| Stress Management | Behavioral | Participants randomized into the stress management group will complete 8 weekly group sessions by phone. The intervention is a telephone adaptation of mindfulness-based cognitive therapy (MBCT) and focuses on building cognitive-behavioral and mindfulness skills to help manage and cope with stress. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and home-based practice assignment. |
|
| Actigraph | Diagnostic Test | The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention. |
|
|
| 6 months |
| Patient Health Questionnaire (PHQ-9) | 6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) | 6 months |
| Sleep quality | 6-month change in sleep efficiency as measured by wrist actigraphy | 6 months |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | United States |
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03766 | United States |
| NYU Winthrop | Mineola | New York | 11501 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Seton Heart (Ascension) - University of Texas, Austin | Austin | Texas | 78705 | United States |
| University of Alberta | Edmonton | Alberta | Canada |
| University of Calgary | Calgary | Canada |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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