Program for managing stress in women after heart attacks
Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
NA · NYU Langone Health · NCT02914483
This study is testing whether an 8-week phone-based stress management program can help women who have had a heart attack feel less stressed and improve their health compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | Female |
| Sponsor | NYU Langone Health (other) |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT02914483 on ClinicalTrials.gov |
What this trial studies
The Women's Heart Attack Research Program focuses on women who have experienced a myocardial infarction (MI). Participants will complete stress questionnaires during their hospitalization and, if they report elevated stress levels two months post-MI, they may enroll in the Stress Ancillary Study. This study involves randomizing participants to either Enhanced Usual Care or an 8-week stress management program delivered via phone sessions. Participants will be followed for six months to assess the impact of the interventions on their stress levels and overall health.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older who have experienced a myocardial infarction and report elevated stress levels two months post-event.
Not a fit: Patients with alternate explanations for troponin elevation or those with severe depressive symptoms or psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve stress management and recovery outcomes for women after a heart attack.
How similar studies have performed: Other studies have shown success in stress management interventions for cardiac patients, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 13 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Univeristy of Florida — Gainesville, Florida, United States (RECRUITING)
- Emory University — Atlanta, Georgia, United States (RECRUITING)
- Johns Hopkins Medical Center — Baltimore, Maryland, United States (RECRUITING)
- Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (RECRUITING)
- NYU Winthrop — Mineola, New York, United States (RECRUITING)
- NYU Langone Medical Center — New York, New York, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
- Ohio State University Medical Center — Columbus, Ohio, United States (RECRUITING)
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Seton Heart (Ascension) - University of Texas, Austin — Austin, Texas, United States (RECRUITING)
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
- University of Calgary — Calgary, Canada (RECRUITING)
Study contacts
- Principal investigator: Harmony R Reynolds, MD — NYU Langone Medical Center
- Study coordinator: Tanya M Spruill, PhD
- Phone: 646-501-2619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardial Infarction, Women, Stress Management