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WithdrawnNCT04094792DepTHUpdated Jan 4, 2022

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

An interventional study of Happify Breather App in Depression, sponsored by Donna Schuman. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Donna Schuman · Not applicable, Interventional, and Treatment

Why this study was withdrawn
PI moving to another university--study will not be done at UK; Coronavirus pandemic will likely delay start at University of Texas at Arlington
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

Although traditionally considered a healthy group, concern is mounting about the health and mental health of college students (Hunt \& Eisenberg, 2010). Mental health problems, such as depression, often go untreated in young college-age adults (Saeb et al., 2015). Depression is associated with poor health outcomes (Rutter et al., 2013). Suicide, often associated with depression, is a leading cause of death in college students (Drapeau \& McIntosh, 2015). Research suggests that stress-related interventions would be useful for college students at risk of poor mental health outcomes (Karatekin, 2017); however less is known about the impact of mobile health interventions on depression in college students.

Studies have shown that heart rate variability (HRV), a potent all-cause morbidity and mortality indicator, is reduced in persons with depressive disorders (Kemp, Quintana, Felmingham, Matthews, \& Jelinek, 2012). Although HRV is typically higher in college-age students because they are often younger, studies have shown that college students HRV biofeedback involves voluntary changes in breathing rate, rhythm, pattern, and quality. Within a few minutes of rhythmic stimulation of the cardiovascular system through slow paced breathing at around six breaths per minute, HRV biofeedback produces robust increases in HRV (Vaschillo, Vaschillo, \& Lehrer, 2006). Emotional regulation, to include depressive symptoms, can be improved through HRV biofeedback (Henriques, Keffer, Abrahamson, \& Horst, 2011; Siepmann, Aykac, Unterdörfer, Petrowski, \& Mueck-Weymann, 2008).

Smart phones offer an expedient way to deliver digital interventions that promote relaxation and improve mood. 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/min using a breath pacer. When the smartphone camera flash is illuminated, red color signal changes (increasing with systole and decreasing with diastole) are measured from the fingertip pressed to the camera lens and sampled at 50 Hz. In a validation study, results obtained from the Happify™ HRV biofeedback Breather app were consistent with Holter monitor results (Stein, 2018). The app is free of charge and publicly available on the iTunes App Store.

The primary objective of the study is to examine the efficacy of the Happify™ Breather app's biofeedback exercise in improving high frequency (HF) heart rate variability (HRV) measures and depression scores in students compared to control. Secondary outcomes are to test the efficacy of the app for anxiety and somatoform symptoms, as well as adherence to the app.

02

Conditions studied

  • Depression

Keywords

  • heart rate variability
  • autonomic function
  • biofeedback
  • mobile health
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Donna Schuman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18-45;
  • University of Kentucky college student;
  • Self-reported low mood;
  • Own a smart phone or iPod (6th Generation or later).

Exclusion criteria

Exclusion Criteria:

  • Score >/= 10 on the PHQ-9 measure from the PHQ-SADS;
  • Self-reported diagnosis of lung disease (e.g., Chronic Obstructive Pulmonary - Disease. Asthma requiring medication), coronary heart disease, stroke, or uncontrolled diabetes (HA1c>7.0);
  • Self-reported history or diagnosis of seizure disorder;
  • Self-reported prescription for tricyclic antidepressants and/or clozapine
  • Current smoking or vaping (use in last 30 days);
  • Previous participation in an HRV biofeedback study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention

    For the intervention group, baseline measures on depression and heart rate variability will be obtained at baseline and post-test (21 days later). Intervention group subjects will use the Breather app twice daily, five minutes each time, for a period of 21 days.

    Device: Happify Breather App

  • No intervention
    Control

    For the control group, baseline measures on depression and heart rate variability will be obtained at baseline and post-test (21 days later).

Interventions

  • DeviceHappify Breather App

    Subjects in the intervention group will be cued to breathe at 6 breaths per minute and will receive real time heart rate variability biofeedback. As they increase HRV, screen elements will become more visually appealing.

06

What researchers measure

Primary outcomes

  1. Depression

    Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 3

    Time frame: 3 weeks

  2. Low Frequency HRV

    Change from baseline to week 3 measured by electrocardiogram

    Time frame: 3 weeks

  3. High Frequency HRV

    Change from baseline to week 3 measured by electrocardiogram

    Time frame: 3 weeks

Secondary outcomes

  1. Anxiety

    Change from baseline to week 3 measured by scores on the GAD-7 (Generalized Anxiety Disorder-7)

    Time frame: 3 weeks

  2. Heart Rate Variability Low Frequency/High Frequency Ratio

    Change from baseline to week 3 measured by electrocardiogram

    Time frame: 3 weeks

  3. Somatoform

    Change from baseline to week 3 measured by scores on the PHQ-15 (Patient Health Questionnaire-15)

    Time frame: 3 weeks

  4. App Adherence

    Number of times app is used over 21 days

    Time frame: 3 weeks

07

Study locations

1 site
  • Donna L. Schuman
    Lexington, Kentucky 40506, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04094792
Lead sponsor
Donna Schuman
Collaborators
Happify Inc., University of Kentucky
Responsible party
Donna Schuman (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
Sep 19, 2019
Start date
Nov 5, 2019 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jan 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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