Status:
UNKNOWN
Studying the Effectiveness and Implementation of Sudarshan Kriya Yoga for Canadian Veterans With PTSD
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Atlas Institute for Veterans and Families
St. Joseph's Health Care London
Conditions:
PTSD
Depressive Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05235828
Start Date
April 25 2022
End Date
July 1 2024
Last Update
March 16 2023
Active Locations (1)
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1
Sinai Health
Toronto, Ontario, Canada, M4M 2B5