Women's Heart Attack Research Program: Stress Ancillary Study
NCT ID: NCT02914483
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2016-08-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enhanced Usual Care (EUC)
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".
Actigraph
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Stress Management
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.
Actigraph
The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
99 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Harmony R Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Univeristy of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
NYU Winthrop
Mineola, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University Medical Center
Columbus, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Seton Heart (Ascension) - University of Texas, Austin
Austin, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
University of Calgary
Calgary, , Canada
Countries
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Central Contacts
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Tanya M Spruill, PhD
Role: CONTACT
Facility Contacts
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C Noel Bairey Merz, MD
Role: primary
Ki Park, MD
Role: primary
Senait Asier
Role: primary
Jeffrey C Trost, MD
Role: primary
Brian J Aldrich
Role: primary
Kevin Marzo, MD
Role: primary
Nisha B Jhalani, MD
Role: primary
Laxmi Mehta, MD
Role: primary
Catalin Toma, MD
Role: primary
Virginia Remeny
Role: primary
References
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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.
Other Identifiers
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16-01104-1
Identifier Type: -
Identifier Source: org_study_id
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