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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Device: Ellipsis Health Voice Application

• Registration Number: NCT05371470
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2023-09-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac rehabilitation plus voice analysis	Ellipsis Health Voice Application	Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.

Primary Outcome Measures

Name	Time	Method
Change in health behaviors	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.
Change in anxiety symptoms	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.
Change in quality of life	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.
Change in depressive symptoms	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.
Change in perceived stress	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States