Sudarshan Kriya Yoga for Canadian Veterans With Post-Traumatic Stress Disorder: A Nation-wide Effectiveness and Implementation Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in PTSD symptoms
研究概览
简要总结
We plan to study the reach, effectiveness, adoption, implementation, and maintenance of the virtually-delivered Sudarshan Kriya Yoga (v-SKY) intervention. We will study effectiveness by comparing the effects of v-SKY to a waitlist control in a randomized controlled trial (RCT) with Canadian military and RCMP veterans with PTSD. Effects of the intervention on PTSD symptom severity, depression, pain, anxiety, and quality of life will be evaluated. We will evaluate the reach, adoption, implementation, and maintenance of the v-SKY intervention amongst veterans, SKY instructors, health professionals, and administrators by interviewing RCT participants, instructors, health professionals, and administrators that work with veterans. Evaluating implementation of a virtual intervention is relevant in both pandemic and post-pandemic contexts where virtual interventions may continue to be more available and possibly preferred by patients and clients.
详细描述
Using a mixed-methods approach guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will conduct a hybrid type II effectiveness/implementation study1 consisting of a randomized controlled trial (RCT) and a parallel implementation evaluation of Sudarshan Kriya Yoga for Canadian veterans.
OBJECTIVES:
To determine the effect of v-SKY on decreasing PTSD symptom severity, quality of life, and depressive, anxiety, and pain symptoms in Canadian veterans affected by PTSD.
To evaluate the implementation of the v-SKY intervention amongst Canadian veterans with PTSD and the health professionals, and administrators that work with veterans, by evaluating the reach, adoption, implementation, and maintenance of the intervention.
RCT RECRUITMENT AND CONSENT: Participants who are veterans of the Canadian Armed Forces (CAF) or Royal Canadian Mounted Police (RCMP) with PTSD will be recruited through various organizations and clinics across Canada. All potential participants will be provided with a consent form and given as much time as needed to consider participation. After this time, informed consent will be obtained from those interested in participating and they will be screened for eligibility by study staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The member of the research team who is assessing outcome measures will be blinded to the randomization outcome.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •CAF or RCMP veteran.
- •Meet criteria for current PTSD as determined by a score of >38 on the PTSD Checklist-5 (PCL-5).
排除标准
- •Participation in another concurrent clinical trial.
- •Intention to begin a new course of Behavioural Therapy (e.g., Cognitive Behavioural Therapy including Prolonged Exposure or Cognitive Processing Therapy) during the intervention period.
- •Past participation in virtual or in-person SKY.
- •Initiated psychotropic medication within 8 weeks prior to the initial screening. Excluded participants could be re-considered for eligibility after stability on medication was achieved.
- •Risk of imminent suicidal intent at screening as per MINI screening and standard tool. Such patients will be advised to visit their local emergency department.
- •Mental disorders including schizophrenia, bipolar I, psychosis of any type.
- •Seizure disorder not well controlled.
- •Moderate or severe substance use disorder as per the MINI.
- •Neurocognitive impairment as determined by a score of 23 or less on the Montreal Cognitive Assessment (MOCA) mini version.
- •Unable to connect to the internet and use Zoom for study assessments and interventions.
- •Inability to provide informed consent.
结局指标
主要结局
Change in PTSD symptoms
时间窗: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
The PCL-5 is a well-validated, widely used, and easy to administer 20-item self-report scale that is used in PTSD research and clinical practice. Change in PCL-5 scores from baseline to post-treatment will be measured. Prolonged effects of the interventions on PTSD symptoms will be captured with the PCL-5 at the follow-up assessments. Responses to each item relate to the four symptom clusters for PTSD, for which separate scores can be measured. These scores will be used for additional analyses.
次要结局
未报告次要终点
研究者
Ross Upshur
Physician researcher
Mount Sinai Hospital, Canada