Myocardial InfarctionHARPNCT02914483
Women's Heart Attack Research Program: Stress Ancillary Study
A study testing Stress Management and Actigraph in people with Myocardial Infarction, run by NYU Langone Health at 14 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Stress Management and Actigraph
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 19 Jan 2017to 24 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Emory University
Atlanta, Georgia, 30322
Seton Heart (Ascension) - University of Texas, Austin
Austin, Texas, 78705
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Ohio State University Medical Center
Columbus, Ohio, 43210
Univeristy of Florida
Gainesville, Florida, 32610
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03766
Cedars-Sinai Medical Center
Los Angeles, California, 90048
NYU Winthrop
Mineola, New York, 11501
NYU Langone Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Canada2 sites
University of Calgary
Calgary
University of Alberta
Edmonton, Alberta
About this study
Official title: Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Enhanced Usual Care, Stress Management, Actigraph
- Keywords
- Myocardial Infarction, Women, Stress Management
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareBehavioural
Also called EUC
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".
Stress ManagementBehavioural
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.
ActigraphDiagnostic test
Also called 'Sleep Watch'
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Other | Not described Receives: Behavioral: Enhanced Usual Care; Diagnostic Test: Actigraph |
| Stress Management | Other | Not described Receives: Behavioral: Stress Management; Diagnostic Test: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10) scores
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Measured: 6 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 6 months
Patient Health Questionnaire (PHQ-9)
6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Measured: 6 months
Sleep quality
6-month change in sleep efficiency as measured by wrist actigraphy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start19 Jan 2017
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harmony R Reynolds, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914483
- Sponsor's protocol ID
- 16-01104-1
- Acronym
- HARP
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2016
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared after the end of the study.
Publications
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.
PubMed 29864732
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02914483
- Acronym / sponsor ID
- HARP / 16-01104-1
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Women, Stress Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Other | Behavioral: Enhanced Usual Care, Diagnostic Test: Actigraph |
| Stress Management | Other | Behavioral: Stress Management, Diagnostic Test: Actigraph |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual CareAlso: EUCParticipants 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". | Behavioural | Enhanced Usual Care (EUC) |
| Stress ManagementParticipants 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. | Behavioural | Stress Management |
| ActigraphAlso: 'Sleep Watch'The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention. | Diagnostic test | Enhanced Usual Care (EUC), Stress Management |
Primary outcome
Perceived Stress Scale (PSS-10) scores
Time frame: 6 months
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)
4 secondary outcomes
Short Form (SF-12) Score
Time frame: 6 months
Seattle Angina Questionnaire-7 Score (SAQ-7)
Time frame: 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Sleep quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 29864732Spruill 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.
- Individual participant dataSharing planned: Yes. De-identified data will be shared after the end of the study.
Related trials for Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harmony R Reynolds, MD principal investigator
NYU Langone Medical Center
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Actigraph in people with Myocardial Infarction, run by NYU Langone Health at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.