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

NCT ID: NCT05371470

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cardiac rehabilitation plus voice analysis

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

Group Type EXPERIMENTAL

Ellipsis Health Voice Application

Intervention Type DEVICE

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

Cardiac rehabilitation only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ellipsis Health Voice Application

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Amir Lerman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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21-012982

Identifier Type: -

Identifier Source: org_study_id

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