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虚拟现实传递苏达尔珊瑜伽(SKY)对加拿大 PTSD 退伍军人的影响:一项全国范围内有效性和实施评估的研究方案。

Virtually-delivered Sudarshan Kriya Yoga (SKY) for Canadian veterans with PTSD: A study protocol for a nation-wide effectiveness and implementation evaluation.

机构信息

Bridgepoint Collaboratory, Lunenfeld-Tanenbaum Research Institute, Sinai Health System, Toronto, Ontario, Canada.

Toronto Rehabilitation Institute, University Hospital Network, Toronto, Ontario, Canada.

出版信息

PLoS One. 2022 Oct 26;17(10):e0275774. doi: 10.1371/journal.pone.0275774. eCollection 2022.

Abstract

BACKGROUND

Post-traumatic stress disorder (PTSD) remains a significant treatment challenge among Canadian veterans. Currently accessible pharmacological and non-pharmacological interventions for PTSD often do not lead to resolution of PTSD as a categorical diagnosis and have significant non-response rates. Sudarshan Kriya Yoga (SKY), a complementary and integrative health (CIH) intervention, can improve symptoms of PTSD. In response to the COVID-19 pandemic, this intervention has pivoted to virtual delivery and may be reaching new sets of participants who face multiple barriers to care.

OBJECTIVE

To evaluate the implementation and effectiveness of virtually delivered Sudarshan Kriya Yoga (SKY) on decreasing PTSD symptom severity, symptoms of depression, anxiety, and pain, and improving quality of life in Canadian veterans affected by PTSD.

METHODS AND ANALYSIS

Using a mixed-methods approach guided by the RE-AIM framework, we will conduct a hybrid type II effectiveness and implementation study of virtually delivered Sudarshan Kriya Yoga (SKY) for Canadian veterans. Effectiveness will be evaluated by comparing virtually delivered SKY to a waitlist control in a single-blinded (investigator and data analyst) randomized controlled trial (RCT). Change in PTSD symptoms (PCL-5) is the primary outcome and quality of life (SF-36), symptoms of depression (PHQ-9), anxiety (GAD-7), and pain (BPI) are secondary outcomes. The SKY intervention will be conducted over a 6-week period with assessments at baseline, 6-weeks, 12-weeks, and 30 weeks. The reach, effectiveness, adoption, implementation, and maintenance of the intervention will be evaluated through one-on-one semi-structured interviews with RCT participants, SKY instructors, health professionals, and administrators that work with veterans.

DISCUSSION

This is the first investigation of the virtual delivery of SKY for PTSD in veterans and aims to determine if the intervention is effective and implementable at scale.

摘要

背景

创伤后应激障碍(PTSD)仍然是加拿大退伍军人面临的重大治疗挑战。目前,可获得的 PTSD 药理学和非药理学干预措施往往不能解决 PTSD 的分类诊断问题,并且有很高的无反应率。苏达尔珊克里亚瑜伽(SKY)是一种补充和综合健康(CIH)干预措施,可以改善 PTSD 的症状。为了应对 COVID-19 大流行,这种干预措施已经转向虚拟交付,可能会接触到新的一组参与者,他们面临着多种护理障碍。

目的

评估虚拟交付苏达尔珊克里亚瑜伽(SKY)对降低 PTSD 症状严重程度、抑郁、焦虑和疼痛症状以及改善受 PTSD 影响的加拿大退伍军人生活质量的实施和有效性。

方法和分析

本研究采用混合方法,以 RE-AIM 框架为指导,对虚拟交付的苏达尔珊克里亚瑜伽(SKY)对加拿大退伍军人 PTSD 的有效性和实施情况进行混合 II 型有效性和实施研究。有效性将通过在单盲(研究者和数据分析员)随机对照试验(RCT)中比较虚拟交付 SKY 与等待名单对照组来评估。PTSD 症状(PCL-5)的变化是主要结局,生活质量(SF-36)、抑郁症状(PHQ-9)、焦虑症状(GAD-7)和疼痛(BPI)是次要结局。SKY 干预将在 6 周内进行,在基线、6 周、12 周和 30 周进行评估。通过对 RCT 参与者、SKY 指导员、与退伍军人合作的卫生专业人员和管理人员进行一对一的半结构化访谈,评估干预措施的可及性、有效性、采用、实施和维持情况。

讨论

这是对 SKY 用于 PTSD 退伍军人的虚拟交付的首次调查,旨在确定该干预措施是否有效且可大规模实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61cd/9605019/40871428f71a/pone.0275774.g001.jpg

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