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

Withdrawn before enrolling · Not applicable

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT04094792

Run by

Donna Schuman

People needed

0

Starts

2019-11-05

Expected to finish

2022-06-01

Last updated by the study team

2022-01-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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