Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.
Department of Psychiatry, Parkwood Institute of Mental Health, 550 Wellington Rd, London, ON, N6C 5J1, Canada.
Trials. 2020 Jul 14;21(1):648. doi: 10.1186/s13063-020-04583-w.
Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience.
This is an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention SKY versus an online control mind-body intervention HEP in frontline hospital and long-term care home staff managing the COVID-19 pandemic.
Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada. Participants will be willing and able to attend via online video conferencing software to participate in the study interventions. Participants must have an adequate understanding of English and be able to sit without physical discomfort for 60 minutes.
Sudarshan Kriya Yoga (SKY): The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher at all times, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 3 hours. Phase I will consist of 5 self-paced online modules of 4-10 minutes each to learn the breath control techniques. Participants will be sent an online survey in REDCap requesting that they self-confirm completion of the Phase I modules. In Phase II, 2 interactive online sessions of 1 hour each will be held on consecutive days with a certified SKY teacher, during which participants will learn the fast, medium and slow breaths. For ease of scheduling, multiple time windows will be offered for Phase II. There will be at least one back up teacher at all times. Both Phase I and II will be completed in the first week. Health Enhancement Program (HEP): The active control arm, HEP, will consist of time-matched online self-paced modules for Phase I. Phase II will consist of mindfulness-based meditation sessions delivered by mental health staff. HEP will be an active treatment program that incorporates mind-body interventions. HEP will consist of time-matched online self-paced modules with psychoeducation on healthy active living as well as interactive modules comprising of guided de-stressing exercises including music therapy, mindfulness and progressive muscle relaxation. Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
The following feasibility outcomes will be measured at the end of the study: (1) rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs. Such measures will be collected on a daily basis through-out the study and tabulated 5 weeks later at the end of the study.
Participants will be randomized after they have electronically signed the consent form and the research staff have confirmed eligibility. We will use REDCap to perform randomization in a 1:1 ratio as well as allocation concealment. REDCap is widely used by health researchers worldwide to significantly reduce data entry and study management errors to improve data fidelity.
BLINDING (MASKING): All study participants will be blinded to the study hypotheses so as to prevent any expectation bias. Group allocation will be masked during analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study will randomize a total of 60 participants in a 1:1 ratio to either SKY or HEP interventions.
Protocol version number 2.0 (June 5, 2020). Recruitment is currently ongoing (starting June 25, 2020). We anticipate to complete recruitment by June 30, 2021 and complete the study by September 30, 2021.
ClinicalTrials.gov protocol ID NCT04368676 (posted April 30, 2020).
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
确定在 COVID-19 大流行和远程试验监测的限制下，对一线医院和长期护理院工作人员进行在线 Sudarshan Kriya Yoga（SKY）随机对照试验（RCT）是否可行。
评估在线版本的 SKY 和/或健康增强计划（HEP）是否会导致自我评估的失眠、焦虑、抑郁和恢复力的改善。
这是一项开放标签可行性随机对照试验（RCT），比较在线呼吸瑜伽干预 SKY 与在线控制身心干预 HEP 在管理 COVID-19 大流行的一线医院和长期护理院工作人员中的应用。
参与者将包括安大略省伦敦市参与管理 COVID-19 患者的一线医院和长期护理院工作人员。参与者将愿意并能够通过在线视频会议软件参加研究干预措施。参与者必须具备足够的英语理解能力，并能够在 60 分钟内无身体不适地坐着。
Sudarshan Kriya Yoga（SKY）：SKY 的在线版本将由至少一名经过认证的加拿大 SKY 教师授课，并在 Art of Living 基金会的 Ronnie Newman 女士的监督下，由至少一名后备教师随时待命。为医疗保健工作者提供的在线 SKY 总时长为 3 小时。第一阶段将包括 5 个自我导向的在线模块，每个模块时长为 4-10 分钟，用于学习呼吸控制技术。参与者将在 REDCap 中收到一份在线调查，要求他们自行确认完成第一阶段模块。在第二阶段，将在连续两天内与认证的 SKY 教师进行 2 次 1 小时的互动在线会议，在此期间，参与者将学习快速、中速和慢速呼吸。为便于安排时间，将为第二阶段提供多个时间窗口。任何时候都将至少有一名后备教师。第一阶段和第二阶段都将在第一周完成。
健康增强计划（HEP）：主动对照组 HEP 将由第一阶段的时间匹配在线自我指导模块组成。第二阶段将由心理健康工作人员进行基于正念的冥想课程。HEP 将是一项包含身心干预的积极治疗计划。HEP 将由时间匹配的在线自我指导模块组成，以及关于健康积极生活的心理教育，以及包括音乐疗法、正念和渐进性肌肉放松在内的互动放松练习模块。在随后的 4 周内，每周将为所有招募的参与者提供 30 分钟的后续随访。
（1）参与者招募率，（2）保留率，（3）数据输入的完整性，（4）干预成本，（5）意外成本。这些措施将在研究期间每天进行测量，并在研究结束后的 5 周后进行总结。
参与者将在他们已经电子签署同意书并且研究人员已经确认符合条件后进行随机分组。我们将使用 REDCap 以 1:1 的比例以及分配隐藏进行随机分组。REDCap 被全球健康研究人员广泛用于显著减少数据录入和研究管理错误，以提高数据保真度。
盲法（屏蔽）：
所有研究参与者都将对研究假设保持盲态，以防止任何期望偏差。在分析过程中，将对分组进行屏蔽。
随机分组的数量（样本量）：
这项研究将随机分配总共 60 名参与者，分为 SKY 或 HEP 干预组，比例为 1:1。
协议版本号 2.0（2020 年 6 月 5 日）。招募工作正在进行中（2020 年 6 月 25 日开始）。我们预计将在 2021 年 6 月 30 日完成招募，并在 2021 年 9 月 30 日完成研究。
ClinicalTrials.gov 协议 ID NCT04368676（2020 年 4 月 30 日发布）。
完整方案作为附加文件附在试验网站上（附加文件 1）。为了加快传播这一材料的速度，熟悉的格式已被删除；这封信是完整方案的主要内容的摘要。
