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Stress Reduction Intervention for Women With Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT02893579
Recruitment Status : Terminated (were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.)
First Posted : September 8, 2016
Last Update Posted : July 19, 2018
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a single center, randomized controlled trial which will include women with ischemic heart disease to receive either a self-directed stress reduction program delivered through a smart-phone application or activity tracking only for the first month ("early SR intervention" and "delayed SR intervention", respectively). Patients will be monitored for 1 month for application use and step counts via telephone or email interview and/or collection of screen-captured data. Baseline questionnaires will be repeated at the end of one month to assess for all primary and secondary measures, at which time the control group (activity tracking only) will be introduced to the intervention program. The early SR intervention group will not receive a new intervention but will be encouraged to continue using the app. Data will be collected for an additional 2 months with all participants in both groups. After the three-month study period, the study will close with the collection of final questionnaire data.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Behavioral: Early SR intervention Behavioral: Delayed SR intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Early Intervention
Stress reduction intervention 1 time a month
Behavioral: Early SR intervention
Self-directed stress reduction program delivered through a smart-phone application

Experimental: Delayed Intervention
Wait list Control
Behavioral: Delayed SR intervention
Activity tracking only for the first month

Primary Outcome Measures :
  1. Seattle Angina Questionnaire [SAQ] [ Time Frame: Change from Baseline to 3 Months ]
    The Seattle Angina Questionnaire is a well-validated descriptive instrument for measuring quality of life across five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. 45 Patient SAQ scores have been found to be independently prognostic of subsequent mortality, hospitalization, and resource use.

  2. Rose Dyspnea Score [ Time Frame: Change from Baseline to 3 Months ]
    The Rose Dyspnea Score provides additional information about patient dyspnea, which is a common complaint in patients with IHD independent of the presence of heart failure.

  3. Patient Health Questionnaire [PHQ-2] [ Time Frame: Change from Baseline to 3 Months ]
    a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive

Secondary Outcome Measures :
  1. Duke Activity Status Index score [ Time Frame: Change from Baseline to 3 Months ]
    independently and incrementally predicts major adverse cardiac events (MACE) in patients post-MI as well as in those with chronic stable heart failure

  2. European Quality of Life- Five Dimensions (EQ-5D) scores [ Time Frame: Change from Baseline to 3 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presence of ischemic heart disease as defined by one or more of the following within the last 2 years:
  • Positive stress test
  • Admission for ACS, PCI, or CABG
  • Typical or atypical ischemic symptoms within one month of enrollment
  • On stable dose of anti-anginal medications for at least 2 months
  • Able and willing to provide informed consent and comply with all aspects of the protocol
  • Owns a smartphone with the ability to download applications for stress reduction and activity tracking
  • English-speaking (apps are not available in other languages)

Exclusion Criteria:

  • Planned for revascularization during the study period
  • Self-reported or chart-reviewed diagnosis of psychotic disorder including schizophrenia or schizoaffective disorder, bipolar disorder
  • Current participation in a cardiac rehab program or planned participation during the study period

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 ClinicalTrials.gov identifier (NCT number): NCT02893579

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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Harmony Reynolds, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02893579    
Other Study ID Numbers: 15-00650
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases