Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Change in Heart Rate Variability
研究概览
简要总结
The purpose of this randomized controlled trial was to compare the effectiveness of an HRV-BF intervention versus a health promotion active control intervention focused on improving mental health symptoms among people experiencing homelessness (PEH), who were residing in Skid Row, Los Angeles. In total, 40 PEH were randomized to either the HRV-BF or an active health promotion control group, and received 8 weekly, 30-minute sessions over a two month period, delivered by a nurse-led community health worker team. Dependent variables of HRV, mental health, anxiety, depression and PTSD were measured at baseline, the 8-week session, and/or 2-month follow up.
详细描述
In this pilot randomized controlled trial, conducted over one year, beginning in April 2021, 40 PEH were recruited from a larger sample of 100 PEH that were participating in a survey on COVID-19. Our outcomes were HRV and symptoms of anxiety, depression and PTSD.
Prior to the intervention, a Community Advisory Board (CAB) met to assess feasibility and acceptability of the HRV-BF program, which was presented in a theater-style approach. The CAB, composed of 6 PEH, and 3 healthcare providers, spoke quite favorably about the program, and provided exceptional feedback in terms of acceptability and feasibility in delivery logistics and cultural sensitivity. PEH shared the high levels of stress and anxiety they were experiencing; how helpful they perceived the program to be, the best timing for delivery, length of time for the intervention (under 60 minutes), and how to minimize attrition. Our study was approved by the Human Subjects Protection Committee at the University of California, Irvine and the University of California, Los Angeles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 and older
- •self-reported as residing in a homeless living condition during the previous night
- •self-reported having used illicit substances or alcohol during the past year
排除标准
- •Persons who:
- •exclusively spoke languages other than English or Spanish
- •were unable to understand informed consent
- •had cardiac deficiency, arrhythmias or pacemakers or who took medications affecting autonomic function.
结局指标
主要结局
Change in Heart Rate Variability
时间窗: Change Assessed during the resting 5-minute period at week 1 and week 8 sessions
Commercially available, medical grade photodetector (photoplethysmography or PPG) sensor and accompanying HRV-BF software application (EmWave Pro Plus, HeartMath) will be used to collect interbeat interval data to produce standard measures of HRV including time-domain measures of SDNN (standard deviation of N-to-N intervals) and RMSSD (Root mean square of successive differences between normal heart beats). Both SDNN and RMSSD are measured in milliseconds (ms). RMSSD is most reflective of vagal tone and is our primary outcome measure.
次要结局
- Assessing Evidence of Drug Use in Urine(Baseline and 8 weeks)
- Anxiety Symptoms(Baseline and 8 weeks)
- Depression Symptoms(Baseline and 8 weeks)
- Physical Disease(Baseline and 8 weeks)
- Mental Health Status(Baseline and 8 weeks)
- Post Traumatic Stress Disorder (PTSD)(Baseline and 8 weeks)
- Drug and Alcohol Use(Baseline and 8 weeks)
研究者
Adeline Nyamathi
Distinguished Professor
University of California, Irvine