Women's Heart Attack Research Program: Stress Ancillary Study
HARP
1 other identifier
interventional
200
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 20, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 11, 2025
May 1, 2025
9.9 years
September 20, 2016
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perceived Stress Scale (PSS-10) scores
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)
6 months
Secondary Outcomes (4)
Short Form (SF-12) Score
6 months
Seattle Angina Questionnaire-7 Score (SAQ-7)
6 months
Patient Health Questionnaire (PHQ-9)
6 months
Sleep quality
6 months
Study Arms (2)
Enhanced Usual Care (EUC)
OTHERStress Management
OTHERInterventions
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".
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.
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Univeristy of Florida
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
Related Publications (1)
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.
PMID: 29864732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harmony R Reynolds, MD
NYU Langone Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2016
First Posted
September 26, 2016
Study Start
August 1, 2016
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
De-identified data will be shared after the end of the study.