Status:
WITHDRAWN
Depression, Trauma, and Health: Efficacy of an mHealth App for Symptom Self-Management in College Students
Lead Sponsor:
Donna Schuman
Collaborating Sponsors:
Happify Inc.
University of Kentucky
Conditions:
Depression
Eligibility:
All Genders
18-45 years
Phase:
NA
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 asse...
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, oft...
Eligibility Criteria
Inclusion
- Age 18-45;
- University of Kentucky college student;
- Self-reported low mood;
- Own a smart phone or iPod (6th Generation or later).
Exclusion
- 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
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04094792
Start Date
November 5 2019
End Date
June 1 2022
Last Update
January 4 2022
Active Locations (1)
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1
Donna L. Schuman
Lexington, Kentucky, United States, 40506