Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2020 Mar 31;10(3):e035862. doi: 10.1136/bmjopen-2019-035862.
Rates of mental health illnesses and burnout are increasing internationally. Therapeutic yoga is increasingly used to improve and maintain physical, mental and emotional well-being and general health. This protocol describes a study to evaluate the effectiveness of an existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme, which combines yoga and psychotherapeutic techniques, in improving mental health and decreasing burnout. Implementation factors will also be evaluated for potential scale-up.
A pragmatic before-after interventional trial design will be used to study changes in occupational participation and mental health outcomes, including anxiety, depression, burnout, functional impairment, insomnia, perceived stress, loneliness, self-compassion and readiness for change in adults experiencing anxiety and burnout. Repeated measures analysis of variance will be used to determine changes in outcome measures over time. Regression and multivariate analyses will be conducted to examine relationships between participant characteristics and outcomes and among various outcomes. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework will be used to guide the analyses.
Approval from the Hamilton Integrated Research Ethics Board has been waived: project number 7082 (full review waived). Informed consent will be obtained prior to enrolling any participant into the study. All data will be kept confidential. Peer-reviewed publications and presentations will target researchers and health professionals.
The ClinicalTrials.gov registry (NCT03973216).
心理健康疾病和倦怠的发病率在全球范围内呈上升趋势。治疗性瑜伽越来越多地被用于改善和维持身体、心理和情绪健康以及整体健康。本方案描述了一项评估现有基于初级保健的团体治疗性瑜伽方案（即压力韧性瑜伽方案）有效性的研究，该方案结合了瑜伽和心理治疗技术，以改善心理健康和减少倦怠。还将评估实施因素，以评估潜在的推广规模。
将使用实用的前后干预试验设计来研究职业参与和心理健康结果的变化，包括焦虑、抑郁、倦怠、功能障碍、失眠、感知压力、孤独、自我同情和改变准备度，以评估焦虑和倦怠的成年人。将使用重复测量方差分析来确定随着时间的推移，结果测量值的变化。将进行回归和多元分析，以检验参与者特征与结果之间以及各种结果之间的关系。采用实施、有效性、可接受性、采用和维持框架来指导分析。
已获得汉密尔顿综合研究伦理委员会的批准豁免：项目编号 7082（全面审查豁免）。在将任何参与者纳入研究之前，将获得知情同意。所有数据都将保密。同行评审的出版物和演讲将针对研究人员和卫生专业人员。
ClinicalTrials.gov 注册表（NCT03973216）。
