search
Back to results

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

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ellipsis Health Voice Application
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myocardial Infarction focused on measuring Cardiac Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac rehabilitation plus voice analysis

Cardiac rehabilitation only

Arm Description

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
November 22, 2022
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05371470
Brief Title
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
Official Title
Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Cardiac Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac rehabilitation plus voice analysis
Arm Type
Experimental
Arm Description
Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.
Arm Title
Cardiac rehabilitation only
Arm Type
No Intervention
Arm Description
Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care.
Intervention Type
Device
Intervention Name(s)
Ellipsis Health Voice Application
Intervention Description
Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in anxiety symptoms
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in perceived stress
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in health behaviors
Description
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.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Albers
Phone
(507) 255-6884
Email
Albers.Diana2@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Lerman, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Albers
Phone
507-255-6884
Email
Albers.Diana2@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs