Stress Reduction Intervention for Women With Ischemic Heart Disease

NCT ID: NCT02893579

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2018-07-06

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Intervention

Stress reduction intervention 1 time a month

Group Type: EXPERIMENTAL

Early SR intervention

Intervention Type: BEHAVIORAL

Self-directed stress reduction program delivered through a smart-phone application

Delayed Intervention

Wait list Control

Group Type: EXPERIMENTAL

Delayed SR intervention

Intervention Type: BEHAVIORAL

Activity tracking only for the first month

Interventions

Early SR intervention

Self-directed stress reduction program delivered through a smart-phone application

Intervention Type: BEHAVIORAL

Delayed SR intervention

Activity tracking only for the first month

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harmony Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00650

Identifier Type: -

Identifier Source: org_study_id