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

Primary Purpose

Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Enhanced Usual Care
Stress Management
Actigraph
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Women, Stress Management

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Univeristy of Florida
  • Emory University
  • Johns Hopkins Medical Center
  • Dartmouth-Hitchcock
  • NYU Winthrop
  • NYU Langone Medical Center
  • Columbia University Medical Center
  • Ohio State University Medical Center
  • St. Luke's University Health Network
  • University of Pittsburgh Medical Center
  • Seton Heart (Ascension) - University of Texas, Austin
  • University of Alberta
  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Enhanced Usual Care (EUC)

Stress Management

Arm Description

Outcomes

Primary Outcome Measures

Perceived Stress Scale (PSS-10) scores
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)

Secondary Outcome Measures

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)
Seattle Angina Questionnaire-7 Score (SAQ-7)
6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7)
Patient Health Questionnaire (PHQ-9)
6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Sleep quality
6-month change in sleep efficiency as measured by wrist actigraphy

Full Information

First Posted
September 20, 2016
Last Updated
June 18, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02914483
Brief Title
Women's Heart Attack Research Program: Stress Ancillary Study
Acronym
HARP
Official Title
Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, Women, Stress Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care (EUC)
Arm Type
Other
Arm Title
Stress Management
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Other Intervention Name(s)
EUC
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Stress Management
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Actigraph
Other Intervention Name(s)
'Sleep Watch'
Intervention Description
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10) scores
Description
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Short Form (SF-12) Score
Description
6-month change in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12)
Time Frame
6 months
Title
Seattle Angina Questionnaire-7 Score (SAQ-7)
Description
6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7)
Time Frame
6 months
Title
Patient Health Questionnaire (PHQ-9)
Description
6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Time Frame
6 months
Title
Sleep quality
Description
6-month change in sleep efficiency as measured by wrist actigraphy
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony R Reynolds, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Univeristy of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
NYU Winthrop
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Seton Heart (Ascension) - University of Texas, Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Calgary
City
Calgary
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared after the end of the study.
Citations:
PubMed Identifier
29864732
Citation
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.
Results Reference
derived

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Women's Heart Attack Research Program: Stress Ancillary Study

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