Alternative Treatments to Help Post Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in Post traumatic stress disorder check list (PCL-5)
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is the third most common mental illness with a lifetime prevalence rate of 9.2% in Canada. Depression and anxiety are common comorbidities making treatment complex. Currently available treatments for PTSD include medications and talk therapies. However, their best combined response rates are around 50%. Our recent pilot feasibility study showed potential benefits of a breathing based meditation intervention called Sudarshan Kriya Yoga (SKY) in PTSD, as an augmentation treatment. The investigators seek to now assess the safety and efficacy of SKY intervention compared to an active control, Health Enhancement Program (HEP) in a double blind randomized controlled trial. The investigators will include PTSD patients with a wide range of trauma experience including road traffic accidents, childhood, physical, emotional or sexual abuse, or recurrent traumas over the lifespan. Patients will be offered a 12-week program of either SKY or HEP interventions as an add-on to their existing treatment schedules. This study will examine if patients with PTSD experience a reduction in PTSD symptoms from baseline to 12-week follow-up, as measured by the PCL-5 after receiving either HEP or SKY.
详细描述
STUDY DESIGN: Single-center, blinded (rater, investigator, and clinician), longitudinal, RCT comparing a 12-week SKY online intervention group to a 12-week HEP online intervention group.
STUDY RECRUITMENT: Participants include men and women (n=130), 18-75 years of age, with PTSD. The study will recruit via referrals from the General Adult Ambulatory, the Traumatic Stress Services Program (TSS), the PTSD clinical research unit and the Geriatric Mental Health Program of London Health Sciences Centre at an expected rate of approximately 1 to 2 participants per week. Referred participants will be individuals who in the opinion of investigators or referring physicians will likely meet inclusion and exclusion criteria. A letter will be sent to primary care physicians in London, ON and surrounding area requesting the referral of potential participants. The letter will be accompanied by a poster advertising the study and by a list of the studies inclusion/exclusion criteria. Posters will also be placed online on the websites of the studies investigators as well as websites and social media sites of relevant organizations such as Project Trauma Support and Ivegotyourback911. Online posters will indicate that individuals should not share or comment on posters to protect their identity. Printed posters will be placed in community centres, libraries, hospitals, medical centres, locations where veterans frequent, and locations where first responders work such as fire halls and police stations. Information sessions will be held at locations where first responders work or may frequent to inform potential participants about the study.
SCREENING AND INITIAL ASSESSMENT: Referred potential participants will be provided with a Letter of Information (LOI) to review and consider. Participants will be given a minimum of 24 hours to review the LOI before being contacted over-the-phone by one of the study Research Assistants (RA). During this initial phone call the RA will answer any questions the potential participants have, briefly explain the study, and invite potential participants to a screening appointment to be conducted either remotely or in person. During the initial screening appointment participants will complete the informed consent process which includes an opportunity to ask any questions. Participants will be screened for inclusion and exclusion criteria by a trained member of the research team. These participants will have clinically diagnosed PTSD, further confirmed through a structured clinical interview, the Clinician-administered PTSD Scale for DSM5-past month version (CAPS5). Any additional diagnoses will be screened by the MINI (Mini International Neuropsychiatric Interview). The CAPS5 will also be used to rule out severe depersonalization and derealization as per exclusion criteria. If the participant is above the age of 65 years of age, they will complete a cognitive screening test using the Mini Mental State Examination, MMSE>24 to rule out significant cognitive impairment. Participants meeting all study criteria who wish to join the study will be enrolled and assigned a unique study identifier e.g. HEPSKY001.
RANDOMIZATION: Participants meeting inclusion criteria will be randomized to either SKY or HEP with equal probability (1:1), stratified by gender, using computer generated randomisation numbers. Concealment of randomisation to outcome assessors and investigators will be ensured by an independent consultant who will perform the randomization. The independent consultant will be responsible for randomization and will inform an unblinded study team member of allocation codes. The unblinded study team member will send an email to study participants informing them of their treatment allocation.
TRIAL INTERVENTIONS: The investigators will offer the two interventions, online via Cisco WebEx, in groups of 6-8 participants on a rolling basis 1. Sudarshan Kriya Yoga (SKY): 1. Participants in the SKY group will undergo a 12-week training course conducted by certified teachers of the Art of Living Foundation. 2. HEP Intervention: Participants in HEP will learn about health promotion, healthy diet, music, and exercise, but will not learn breathing techniques, or meditation. HEP will be delivered by trained staff.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Raters, investigators and physicians will not be aware of participant treatment allocation.
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
- •Between the age of 18 and
- •Has confirmed Axis 1 diagnosis of PTSD as per CAPS5
- •Sufficiently able to hear allowing them to follow verbal instructions. Able to communicate sufficiently in English.
- •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.
- •Access to a device with a camera and microphone, internet access, and a private space large enough to accommodate a yoga mat (a yoga mat is not required a comfortable floor space or blanket can be substituted).
排除标准
- •Currently participating in other studies on PTSD treatment.
- •Score severe or extreme on Depersonalization (item 29) or Derealization (item 30) of CAPS
- •Have other significant mental health diagnosis including bipolar disorder, Schizophrenia, Neurocognitive disorder, and/or severe Personality Disorder (confirmed by Psychiatrist and MINI).
- •Have significant substance dependence, or for those that have significant substance use disorder (have been regularly using within 6 weeks prior to commencement of intervention) or are unable to attend the intervention and assessment sessions while not under the influence of a substance.
- •Have a risk of suicide as elicited by clinical interview (MINI).
- •Have psychotic episodes within the past 12 months.
- •Have a 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
- •Non-professionals with complex PTSD. Professionals include those who have served in the Canadian armed forces, are public safety personnel or are health care professionals.
- •Currently practice any type of formal meditation, mindfulness or breathing techniques regularly.
- •Have serious cardiovascular disease in the past 12 months (i.e.myocardial infarction, stroke, uncontrolled hypertension or TIA), or a past history of neurological disease (including Parkinson's Disease), seizures, or diabetic neuropathy.
- •Major surgery within 8 weeks prior to commencement of the intervention, or a scheduled major surgery during the intervention period.
- •Have mental health difficulties that has prevented participant from leaving the house, and/or missed appointments in last 3 months.
- •Have vacation plans that will interfere with participant's ability to participate in the study.
结局指标
主要结局
Change in Post traumatic stress disorder check list (PCL-5)
时间窗: Change from baseline to weeks 4, 8, 12 and 26.
The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Participants will be asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score ranging from 0 to 80, with higher scores indicating more severe symptoms of PTSD.
次要结局
- Change in Hamilton Depression Scale (HAMD-17)(Change from baseline to weeks 4, 8, 12 and 26.)
- Change in heart rate(Change from baseline to week 12 and week 26.)
- Change in Toronto Side Effects Scale (TSES)(Change from baseline to weeks 4, 8, 12 and 26)
- Change in Mean Systolic Blood Pressure as measured by plethysmograph.(Change from baseline to week 12 and week 26.)
- Change in Heart Rate Variability (HRV).(Change from baseline to week 12 and week 24.)
- Change in Beck's Depression Inventory (BDI)(Change from baseline to weeks 4, 8, 12 and 26)
- Change in Hamilton Anxiety Scale (HAM-A)(Change from baseline to weeks 4, 8, 12 and 26.)
- Change in Mean Diastolic Blood Pressure as measured by plethysmograph.(Change from baseline to week 12 and week 26.)
- Change in blood levels of C- Reactive Protein (CRP).(Change from baseline to week 12 and week 26.)
- Change in blood levels of Interleukin-6 (IL-6)(change from baseline to week 12 and 24.)
- Change in blood levels of glutathione(Change from baseline to week 12 and week 24.)
- Change in World Health Organization Quality of Life Scale (WHOQOL-Bref)(Change from baseline ato weeks 4, 8, 12 and 26)
- Change in blood levels of malondialdehyde (MDA)(Change from baseline to week 12 and week 24.)
- Change in blood levels of total antioxidant capacity(Change from baseline to week 12 and week 24.)
研究者
Kamini Vasudev
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's