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Withdrawn Not applicable Interventional Accepts healthy volunteers

Depression, Trauma, and Health: Efficacy of an mHealth App for Symptom Self-Management in College Students

ClinicalTrials.gov ID: NCT04094792

Public ClinicalTrials.gov record NCT04094792. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Depression, Trauma, and Health (DepTH): Efficacy of an mHealth App for Symptom Self-Management in College Students

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study is designed to examine the efficacy of a mobile application heart rate variability biofeedback exercise on heart rate variability and depression. The main objective of this study is to assess the Breather app manufactured by Happify, Inc., as a tool for improving levels of depression and heart rate variability in college students.Happify™ Breather is a mobile app that provides users with HRV biofeedback aimed at improving mental health and wellness. Breather uses HRV sensors to help users control breathing, leading to calm and relaxation. The more relaxed users are, the more visually reinforcing scene elements will appear in the underwater environment of the game. Breather uses an optical sensor in a smartphone camera. During app use, users are cued by the app to breathe at 6 cycles/minute using a breath pacer. When the smartphone camera flash is illuminated, color signal changes are measured from the fingertip pressed to the camera lens. The study population is college students who score in the clinical range on the PHQ-9. Secondary outcomes include anxiety, somatoform symptoms, and app adherence.

Study identification

NCT ID
NCT04094792
Recruitment status
Withdrawn
Study type
Interventional
Phase
Not applicable
Lead sponsor
Donna Schuman
Other
Enrollment
Not listed

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 4, 2019
Primary completion
Apr 30, 2022
Completion
May 31, 2022
Last update posted
Jan 3, 2022

2019 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Donna L. Schuman Lexington Kentucky 40506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04094792, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 3, 2022 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04094792 live on ClinicalTrials.gov.

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