Women's Heart Attack Research Program: Stress Ancillary Study (HARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02914483
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : December 14, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Behavioral: Enhanced Usual Care Behavioral: Stress Management Diagnostic Test: Actigraph Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
Study Start Date : August 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Enhanced Usual Care (EUC) Behavioral: Enhanced 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".
Other Name: EUC

Diagnostic Test: Actigraph
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Other Name: 'Sleep Watch'

Stress Management Behavioral: Stress 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 Test: Actigraph
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Other Name: 'Sleep Watch'

Primary Outcome Measures :
  1. Perceived Stress Scale (PSS-10) scores [ Time Frame: 6 months ]
    6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)

Secondary Outcome Measures :
  1. Short Form (SF-12) Score [ Time Frame: 6 months ]
    6-month change in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12)

  2. Seattle Angina Questionnaire-7 Score (SAQ-7) [ Time Frame: 6 months ]
    6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7)

  3. Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]
    6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)

  4. Sleep quality [ Time Frame: 6 months ]
    6-month change in sleep efficiency as measured by wrist actigraphy

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02914483

Contact: Tanya M Spruill, PhD 646-501-2619
Contact: Harmony R Reynolds, MD 646-501-0302

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Contact: Nisha B Jhalani, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
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Contact: Laxmi Mehta, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Thomas Parsons   
Principal Investigator: Dwithiya Thomas, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Catalin Toma, MD         
United States, Texas
Seton Heart (Ascension) - University of Texas, Austin Recruiting
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Contact: Virginia Remeny         
Principal Investigator: Caitlin Giesler, MD         
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Harmony R Reynolds, MD NYU Langone Medical Center

Responsible Party: New York University School of Medicine Identifier: NCT02914483     History of Changes
Other Study ID Numbers: 16-01104
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared after the end of the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Myocardial Infarction
Stress Management

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases