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

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ClinicalTrials.gov Identifier: NCT02914483
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE September 20, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE August 1, 2016
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Perceived Stress Scale (PSS-10) scores [ Time Frame: 6 months ]
6-month change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
Perceived Stress Scale (PSS-10) scores [ Time Frame: 1 year ]
Proportion of women with MI who have reduction of perceived stress as measured by PSS Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • 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)
  • 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)
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]
    6-month change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
  • Sleep quality [ Time Frame: 6 months ]
    6-month change in sleep efficiency as measured by wrist actigraphy
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Short Form (SF-12) Score [ Time Frame: 1 year ]
    The 12-Item Short Form Health Survey (SF-12)
  • Seattle Angina Questionnaire-7 Score (SAQ-7) [ Time Frame: 1 year ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 1 Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Women's Heart Attack Research Program: Stress Ancillary Study
Official Title  ICMJE Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • 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
  • 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'
Study Arms  ICMJE
  • Enhanced Usual Care (EUC)
    Interventions:
    • Behavioral: Enhanced Usual Care
    • Diagnostic Test: Actigraph
  • Stress Management
    Interventions:
    • Behavioral: Stress Management
    • Diagnostic Test: Actigraph
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02914483
Other Study ID Numbers  ICMJE 16-01104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared after the end of the study.
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harmony R Reynolds, MD NYU Langone Medical Center
PRS Account NYU Langone Health
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP