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

NCT05371470 | Enrolling By Invitation FDA Device

• 1 other identifier: 21-012982
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Cardiac rehabilitation plus voice analysis

EXPERIMENTAL

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

Device: Ellipsis Health Voice Application

Cardiac rehabilitation only

NO INTERVENTION

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

Interventions

Ellipsis Health Voice Application DEVICE

Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety

Cardiac rehabilitation plus voice analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• 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

You may not qualify if:

• Cardiac transplant
• Active substance use
• Neurocognitive disorder
• Active psychosis
• Mania diagnosis
• Active suicidality
• Uncontrolled bipolar disorder

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Virend Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: September 21, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)