Stress Reduction Intervention for Women With Ischemic Heart Disease
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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