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Enrolling by invitation NCT05371470

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

No phase Interventional Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ellipsis Health Voice Application.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Ellipsis Health Voice Application
    Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety

Primary outcome measures

  • Change in depressive symptoms [Time frame: Baseline, 12 weeks]
  • Change in anxiety symptoms [Time frame: Baseline, 12 weeks]
  • Change in perceived stress [Time frame: Baseline, 12 weeks]
  • Change in quality of life [Time frame: Baseline, 12 weeks]
  • Change in health behaviors [Time frame: Baseline, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05371470 · 21-012982

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗