Sudarshan Kriya Yoga (SKY) Versus Wait List Control (WLC) in Post Traumatic Stress Disorder: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Reduction in PTSD symptoms as assessed by the clinician administered PCL-5 (Post Traumatic Stress Disorder Check List).
研究概览
简要总结
Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control (WLC) to assess the effects of this intervention on symptoms of PTSD, depression, anxiety, quality of life, autonomic symptoms, and blood inflammatory markers.
详细描述
A single-center, single blind longitudinal randomized controlled naturalistic trial comparing a 12 week Sudarshan Kriya Yoga Trauma Relief Program (SKY) intervention to a wait list control (WLC) group.
Research participants will be men and women, 18-75 years of age, who have PTSD. The study will recruit from the general adult ambulatory mental health clinics as well as the geriatric mental health program in London.
Potential participants will be screened as per inclusion and exclusion criteria by trained research staff. These patients will already have clinically diagnosed PTSD by a psychiatrist and any other comorbid diagnoses would have already been confirmed. However, for research purposes a diagnosis of PTSD will be confirmed through a structured clinical interview specifically the MINI (Mini International neuropsychiatric Interview) and the Clinician-administered PTSD Scale for DSM5- past month version (CAPS5). CAPS5 will also be used to rule out exclusion criteria of severe depersonalization and derealization. The scales will be administered by a trained research staff and confirmed by a psychiatrist.
The MINI will also be used to assess for suicidality. If the total score on Questions C1 and C2 is more than 5 at any time during the study then this will be reported to the PI who will further assess the patient for safety and risk assessment.
If the participant is above the age of 65 years of age they will also be asked to complete a cognitive screening test (Mini Mental State Examination, MMSE) to ensure they are not suffering from any memory impairments.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an Axis 1 diagnosis of PTSD as per CAPS5 (Clinician Administered PTSD Scale for DSM 5- past month version) criteria.
- •If participants are using antidepressants, they must be at therapeutic doses for a minimum of four weeks prior to commencing the study. Patients who are not willing to take any medications will also be eligible for the study
- •Sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 60 minutes.
- •Willing and able to attend 6 initial SKY training sessions and 75% of follow up sessions
- •Not pregnant and willing to remain not pregnant for the duration of the study
排除标准
- •They are currently participating in other similar studies.
- •If the patient scores severe or extreme on Depersonalization (item 29) or Derealization (item 30) items of CAPS
- •Other significant mental health diagnosis including substance dependence, Neurocognitive disorder, Obsessive Compulsive Disorder, Panic Disorder, Bipolar disorder and/or Personality disorder (confirmed by Psychiatrist and MINI)
- •High risk of suicide as elicited by clinical interview (MINI).
- •Psychotic episodes within the past 12 months.
- •Traumatic Brain Injury (TBI) as defined by loss of consciousness for more than 20 minutes and/or Glasgow Coma Scale score less than or equal to
- •(The researcher will use self-reported histories to screen for traumatic brain injury and if necessary confirmed by medical records.
- •Currently practicing any type of formal meditation, mindfulness or breathing techniques regularly.
- •Serious cardiovascular disease in the past 12 months (i.e. myocardial infarction, stroke, TIA, uncontrolled hypertension), or a past history of neurological disease (including Parkinson's Disease), seizures, or diabetic neuropathy
- •Major surgery within 6 weeks prior to commencement of the intervention, or a scheduled major surgery during the intervention period. (This is due to the physical rigor of the breathing techniques).
研究组 & 干预措施
Sudarshan Kriya Yoga Trauma Relief Program (SKY)
Participants will receive training in SKY soon after completing baseline assessments.
干预措施: Sudarshan Kriya Yoga Trauma Relief Program (SKY) (Other)
wait list control (WLC)
Participants will receive training in SKY after 12 weeks have passed since the baseline assessment.
结局指标
主要结局
Reduction in PTSD symptoms as assessed by the clinician administered PCL-5 (Post Traumatic Stress Disorder Check List).
时间窗: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
The clinician administered PCL-5 (Post Traumatic Stress Disorder Check List). willl be used to assess a change in PTSD symptoms from baseline to weeks 4, 8, 12, and 24.
次要结局
- Improvement in blood pressure as assessed by manually using a standard plethysmograph.(Change from baseline to: 12 weeks, and 24 weeks.)
- Reduction in depression symptoms as assessed by the clinician administered HAM-D 17 (Hamilton Depression Score).(Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Improvement in blood inflammatory markers as measured by enzyme-linked immunosorbent assay.(Change from baseline to: 12 weeks, and 24 weeks.)
- Reduction in depression symptoms using self-rated BDI 21 (Beck's Depression Inventory).(Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Improvement in autonomic parameters including heart rate variability and heart rate as assessed by a Bluetooth enabled Polar H7 Heart Rate Sensor.(Change from baseline to: 12 weeks, and 24 weeks.)
- Reduction in anxiety symptoms as assessed by the HAM-A (Hamilton Anxiety Scale).(Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in quality of life as assessed by the WHOQOL-Bref (World Health Organization Quality of Life Scale).(Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Improvement in the mean respiratory rate as measured manually.(Change from baseline to: 12 weeks, and 24 weeks.)
研究者
Kamini Vasudev
Assistant Professor
Lawson Health Research Institute