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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction

• 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: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

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

Inclusion Criteria

1. ≥ 18 years
2. Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge
3. Owns a smartphone
4. Willing to download and use a smartphone app
5. Able to read, write, and speak English

Exclusion Criteria

1. Cardiac transplant
2. Active substance use
3. Neurocognitive disorder
4. Active psychosis
5. Mania diagnosis
6. Active suicidality
7. Uncontrolled bipolar disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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