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

NCT04094792 | Withdrawn FDA Device

• 1 other identifier: 53054
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

heart rate variability; autonomic function; biofeedback; mobile health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Anxiety

  3 weeks

• Heart Rate Variability Low Frequency/High Frequency Ratio

  3 weeks

• Somatoform

  3 weeks

• App Adherence

  3 weeks

Study Arms (2)

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.

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).

Interventions

Happify Breather App DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Donna Schuman: lead
• Happify Inc.: collaborator
• University of Kentucky: collaborator

Study Sites (1)

Donna L. Schuman

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two-group randomized controlled efficacy trial

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: November 5, 2019
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)