Women's Heart Attack Research Program: Stress Ancillary Study

Myocardial Infarction Clinical Trial

— HARP  

Official title:

Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02914483
• Other study ID #: 16-01104-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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".
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary
Canada	University of Alberta	Edmonton	Alberta
United States	Emory University	Atlanta	Georgia
United States	Seton Heart (Ascension) - University of Texas, Austin	Austin	Texas
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Univeristy of Florida	Gainesville	Florida
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	NYU Winthrop	Mineola	New York
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale (PSS-10) scores	6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)	6 months
Secondary	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)	6 months
Secondary	Seattle Angina Questionnaire-7 Score (SAQ-7)	6-month change in disease-specific health status as measured by the Seattle Angina Questionnaire (SAQ-7)	6 months
Secondary	Patient Health Questionnaire (PHQ-9)	6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)	6 months
Secondary	Sleep quality	6-month change in sleep efficiency as measured by wrist actigraphy	6 months