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.
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.
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Happify Breather App |
| Control | No intervention | For 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.
Depression
Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 3
Measured: 3 weeks
Low Frequency HRV
Change from baseline to week 3 measured by electrocardiogram
Measured: 3 weeks
High Frequency HRV
Change from baseline to week 3 measured by electrocardiogram
Measured: 3 weeks
Secondary outcomes (4)
Anxiety
Change from baseline to week 3 measured by scores on the GAD-7 (Generalized Anxiety Disorder-7)
Measured: 3 weeks
Heart Rate Variability Low Frequency/High Frequency Ratio
Change from baseline to week 3 measured by electrocardiogram
Measured: 3 weeks
Somatoform
Change from baseline to week 3 measured by scores on the PHQ-15 (Patient Health Questionnaire-15)
Measured: 3 weeks
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.
- First posted19 Sep 2019
- Study start5 Nov 2019 (estimated)
- Primary completion1 May 2022 (estimated)
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Donna Schuman
- Sponsor type
- University, hospital or other
- Collaborators
- Happify Inc., University of Kentucky
- Responsible party
- Sponsor-investigator, Donna Schuman, University of Kentucky
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Trauma, and Health (DepTH): Efficacy of an mHealth App for Symptom Self-Management in College Students
- ClinicalTrials.gov ID
- NCT04094792
- Acronym / sponsor ID
- DepTH / 53054
- Conditions
- Depression
- Keywords
- heart rate variability, autonomic function, biofeedback, mobile health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Donna SchumanUniversity, hospital or other
- Collaborators
- Happify Inc., University of Kentucky
- Study start
- 5 Nov 2019 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-group randomized controlled efficacy trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Happify Breather AppFor 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. |
| Control | No intervention | –For the control group, baseline measures on depression and heart rate variability will be obtained at baseline and post-test (21 days later). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45;
- University of Kentucky college student;
- Self-reported low mood;
- Own a smart phone or iPod (6th Generation or later).
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happify Breather AppSubjects 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. | Device | Intervention |
Primary outcome
Depression
Time frame: 3 weeks
Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 3
Low Frequency HRV
Time frame: 3 weeks
Change from baseline to week 3 measured by electrocardiogram
High Frequency HRV
Time frame: 3 weeks
Change from baseline to week 3 measured by electrocardiogram
4 secondary outcomes
Anxiety
Time frame: 3 weeks
Heart Rate Variability Low Frequency/High Frequency Ratio
Time frame: 3 weeks
Somatoform
Time frame: 3 weeks
App Adherence
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.