Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
Study Details
Study Description
Brief Summary
The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cardiac rehabilitation plus voice analysis Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app. |
Device: Ellipsis Health Voice Application
Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety
|
| No Intervention: Cardiac rehabilitation only Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care. |
Outcome Measures
Primary Outcome Measures
- Change in depressive symptoms [Baseline, 12 weeks]
Measured using the self-reported Patient Health Questionnaire-9 (PHQ-9) to assess for major depressive disorder. Possible score range from 0 to 27, with higher scores indicating a worse outcome/greater severity of depressive symptoms.
- Change in anxiety symptoms [Baseline, 12 weeks]
Measured using the self-reported Generalized Anxiety Disorder 7-Item Scale (GAD-7) that assesses anxiety symptoms. Possible score range from 0 to 21, with higher scores indicating a worse outcome/greater severity of anxiety symptoms.
- Change in perceived stress [Baseline, 12 weeks]
Measured using the self-reported Perceived Stress Scale-14 (PSS-14), a 14 item questionnaire which assesses the degree to which situations in life are stressful within the last month. Each item is scored on a 5 point Likert scale from 0 (never) to 4 (very often), higher total scores indicate a worse outcome/greater severity of perceived stress.
- Change in quality of life [Baseline, 12 weeks]
Measured using the self-reported abbreviated generic Quality of Life Scale developed through the World Health Organization (WHOQOL-BREF) questionnaire that assesses an individual's perceptions of their health and well-being within the last two weeks. Each item is scored on a 5 point Likert scale, higher scores indicate greater perceived quality of life.
- Change in health behaviors [Baseline, 12 weeks]
Measured using the self-reported Current Health Behaviors (HB) questionnaire, a 13 item questionnaire which assesses behaviors and life circumstances during the last month. Each item is scored on a 10 point Likert scale, higher scores indicate better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed myocardial infarction (MI).
-
Enrolled in cardiac rehabilitation program to start within 4 weeks from hospital discharge due to MI.
-
Owns a smartphone.
-
Willing to download and use a smartphone app.
-
Able to read, write, and speak English.
Exclusion Criteria:
-
Pregnancy.
-
Actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments.
-
Cardiac transplant.
-
Active substance use.
-
Neurocognitive disorder.
-
Active psychosis.
-
Mania diagnosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Amir Lerman, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-012982