Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness (BREATH): an RCT for Frontline Hospital and Long-term Care Home Staff Managing the COVID-19 Pandemic
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Rate of participant recruitment
研究概览
简要总结
This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).
详细描述
The COVID-19 pandemic continues to escalate as a global health threat, leading to devastating impacts on the healthcare system. Frontline healthcare workers are dealing with increased demands and fears for their own, as well as their family's safety. Adding to the stress is the limited ability to maintain social connectedness as physical distancing measures are in place. The investigators plan to conduct an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention called Sudarshan Kriya Yoga (SKY) (n=30) versus an online control mind-body intervention called the Health Enhancement Program (HEP) (n=30) in 60 hospital and long term care frontline staff that are managing COVID-19 patients. Participants will be blinded to the treatment hypothesis while data analyst will be blinded to treatment allocation. Both SKY and HEP will be taught online in two phases in the first week followed by weekly reinforcement sessions for the following 4 weeks. Feasibility measures will be assessed as well as self-rated measures of insomnia, anxiety, depression, and resilience. The investigators expect that it will be feasible to conduct an online RCT of two mind-body interventions, SKY and HEP, in staff managing the COVID-19 pandemic, and that the investigators will be able to remotely monitor safety and efficacy of these interventions.
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
- Single (Outcomes Assessor)
盲法说明
Participants will be blinded to the treatment hypothesis while the data analyst will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be frontline hospital or long-term care home staff involved in the management of COVID-19 patients in Canada or The United States of America.
- •Participants will be aged 18 to
- •Participants will be willing and able to attend, via WebEx software, the introductory phase of SKY or HEP, as well as at least two of the four weekly follow-up sessions
- •Have sufficient hearing to follow verbal instructions.
- •Have an adequate understanding of English.
- •Able to sit without physical discomfort for 60 minutes.
- •Not pregnant and willing to remain not pregnant for the duration of the study.
排除标准
- •Inability to independently provide informed consent.
- •Current suicidality as assessed by the suicide item of the Patient Health Questionnaire-9 scale.
- •History of bipolar disorder.
- •History of chronic PTSD.
- •History of schizophrenia or schizoaffective disorder.
- •Currently practice any type of formal meditation, mindfulness, or breathing techniques regularly (greater than 3 times per week).
- •History of complex PTSD.
结局指标
主要结局
Rate of participant recruitment
时间窗: 1 year
The number of participants recruited per month will be calculated as a feasibility measure.
Completeness of data entry
时间窗: 1 year
The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms.
Rate of retention
时间窗: 1 year
The retention rate of participants will be calculated as a feasibility measure.
Cost of interventions
时间窗: 1 year
The cost of both study interventions will be calculated to assess the total study cost for interventions and the cost per participant. This information will be used as a feasibility measure.
Unexpected costs
时间窗: 1 year
The total of unexpected costs will be calculated as a feasibility measure.
次要结局
- Change in Athens Insomnia Scale(Change from Week 0 to week 3 and to week 5)
- Change in Patient Health Questionnaire 9(Change from Week 0 to week 3 and to week 5)
- Change in Connor-Davidson Resilience Scale(Change from Week 0 to week 3 and to week 5)
- Change in Generalized Anxiety Disorder 7-item scale(Change from Week 0 to week 3 and to week 5)
研究者
Akshya Vasudev
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's