Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Ellipsis Health Voice Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge. Owns a smartphone. Willing to download and use a smartphone app. Able to read, write, and speak English. Exclusion Criteria: Actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments. Cardiac transplant. Active substance use. Neurocognitive disorder. Active psychosis. Mania diagnosis. Active suicidality

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac rehabilitation plus voice analysis<br>Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app. | Device: Ellipsis Health Voice Application<br>* Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety<br>|
| No Intervention: Cardiac rehabilitation only<br>Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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. | Baseline, 12 weeks | 
| Change in anxiety symptoms | 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. | Baseline, 12 weeks | 
| Change in perceived stress | 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. | Baseline, 12 weeks | 
| Change in quality of life | 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. | Baseline, 12 weeks | 
| Change in health behaviors | 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. | Baseline, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Rehabilitation