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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371470
• Other study ID #: 21-012982
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Diana Albers
• Phone: (507) 255-6884
• Email: Albers.Diana2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Ellipsis Health Voice Application
Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials