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临床试验/NCT04094792
NCT04094792撤回不适用

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

Donna Schuman2 个研究点 分布在 1 个国家开始时间: 2019年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
High Frequency HRV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

High Frequency HRV

时间窗: 3 weeks

Change from baseline to week 3 measured by electrocardiogram

Low Frequency HRV

时间窗: 3 weeks

Change from baseline to week 3 measured by electrocardiogram

Depression

时间窗: 3 weeks

Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 3

次要结局

  • Anxiety(3 weeks)
  • Heart Rate Variability Low Frequency/High Frequency Ratio(3 weeks)
  • Somatoform(3 weeks)
  • App Adherence(3 weeks)

研究者

发起方
Donna Schuman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Donna Schuman

Principal Investigator

University of Kentucky

研究点 (2)

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