Stress Reduction Intervention for Women With Ischemic Heart Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Behavioral: Early SR intervention
* Behavioral: Delayed SR intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>Stress reduction intervention 1 time a month | Behavioral: Early SR intervention<br>* Self-directed stress reduction program delivered through a smart-phone application<br>|
| Experimental: Delayed Intervention<br>Wait list Control | Behavioral: Delayed SR intervention<br>* Activity tracking only for the first month<br>|

What is the study measuring?
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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 |