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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Device: Happify Breather App

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Donna L. Schuman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 3	3 weeks
Low Frequency HRV	Change from baseline to week 3 measured by electrocardiogram	3 weeks
High Frequency HRV	Change from baseline to week 3 measured by electrocardiogram	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Change from baseline to week 3 measured by scores on the GAD-7 (Generalized Anxiety Disorder-7)	3 weeks
Heart Rate Variability Low Frequency/High Frequency Ratio	Change from baseline to week 3 measured by electrocardiogram	3 weeks
Somatoform	Change from baseline to week 3 measured by scores on the PHQ-15 (Patient Health Questionnaire-15)	3 weeks
App Adherence	Number of times app is used over 21 days	3 weeks

Collaborators and Investigators

• Sponsor: Donna Schuman
• Collaborators: University of Kentucky; Happify Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 5, 2019
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: biofeedback; mobile health; autonomic function; heart rate variability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 53054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes