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Enrolling by Invitation

NCT Number: NCT05371470

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

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

Treatment and study plan

Ellipsis Health Voice Application

Device

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

Primary outcomes

  1. Change in depressive symptoms

    Time frame: 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.

  2. Change in anxiety symptoms

    Time frame: 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.

  3. Change in perceived stress

    Time frame: 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.

  4. Change in quality of life

    Time frame: 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.

  5. Change in health behaviors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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