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DepressionDepTHNCT04094792

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

A study testing Happify Breather App in people with Depression, run by Donna Schuman at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
Happify Breather App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
5 Nov 2019to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Donna L. Schuman

    Lexington, Kentucky, 40506

Other trials in United States

About this study

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

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.

Conditions
Depression
Being tested
Happify Breather App
Keywords
heart rate variability, autonomic function, biofeedback, mobile health
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Happify Breather AppDevice

    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.

Study groups in NCT04094792
Study groupRoleWhat they receive
InterventionExperimentalFor 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.
Receives: Device: Happify Breather App
ControlNo interventionFor the control group, baseline measures on depression and heart rate variability will be obtained at baseline and post-test (21 days later).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

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

    Measured: 3 weeks

  2. Low Frequency HRV

    Change from baseline to week 3 measured by electrocardiogram

    Measured: 3 weeks

  3. High Frequency HRV

    Change from baseline to week 3 measured by electrocardiogram

    Measured: 3 weeks

Secondary outcomes (4)
  1. Anxiety

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

    Measured: 3 weeks

  2. Heart Rate Variability Low Frequency/High Frequency Ratio

    Change from baseline to week 3 measured by electrocardiogram

    Measured: 3 weeks

  3. Somatoform

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

    Measured: 3 weeks

  4. App Adherence

    Number of times app is used over 21 days

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start5 Nov 2019 (estimated)
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Why it stopped: PI moving to another university--study will not be done at UK; Coronavirus pandemic will likely delay start at University of Texas at Arlington

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two-group randomized controlled efficacy trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094792
Sponsor's protocol ID
53054
Acronym
DepTH
Status last verified
Jan 2022
First submitted
16 Sep 2019
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Happify Breather App in people with Depression, run by Donna Schuman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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