Stress Reduction Intervention for Women With Ischemic Heart Disease

Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Behavioral: Early SR intervention; Behavioral: Delayed SR intervention

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seattle Angina Questionnaire [SAQ]	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.	Change from Baseline to 3 Months
Rose Dyspnea Score	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.	Change from Baseline to 3 Months
Patient Health Questionnaire [PHQ-2]	a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive	Change from Baseline to 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duke Activity Status Index score	independently and incrementally predicts major adverse cardiac events (MACE) in patients post-MI as well as in those with chronic stable heart failure	Change from Baseline to 3 Months
European Quality of Life- Five Dimensions (EQ-5D) scores		Change from Baseline to 3 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Harmony Reynolds, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 15-00650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No