Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Women, Stress Management
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.
Interventions
BEHAVIORALEnhanced Usual Care
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.
BEHAVIORALStress Management
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.
DIAGNOSTIC_TESTActigraph
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS-10) scores | 6 months | 6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Patient Health Questionnaire (PHQ-9) | 6 months | 6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) |
| Sleep quality | 6 months | 6-month change in sleep efficiency as measured by wrist actigraphy |
Countries
Canada, United States
Contacts
Primary ContactTanya M Spruill, PhD
Backup ContactHarmony R Reynolds, MD
Outcome results
None listed