Recruiting

Sudarshan Kriya Yoga

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT05235828

Conditions

PTSD

Depressive Symptoms

Anxiety

Pain

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sudarshan Kriya Yoga (SKY)

Study Details

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 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.

Conditions

PTSD

Depressive Symptoms

Anxiety

Pain

Quality of Life

Study ID

NCT05235828

Start date

Apr 25, 2022

Status verified date

Mar, 2023

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active intervention (ACT) group

8-12 participants will meet for 3-hour sessions for the first 5 days of the intervention. This is followed by five weeks of 1-hour sessions twice per week. In total, the intervention will be 15 sessions that run for a total of 25 hours over 6-weeks. Experienced and licensed SKY instructors from the International Association for Human Values (IAHV) and Art of Living Foundation (AOLF) will provide the intervention through video calls. Instructors will guide participants through the v-SKY intervention through visual demonstrations and verbal guidance. All sessions will be delivered virtually using Zoom. Sessions will not be recorded.

no intervention: Waitlist control (WLC) group

8-12 participants will not receive the intervention for 6-weeks. The 6-weeks will line up with the v-SKY intervention that the ACT group receives. After the waitlist period, the WLC group will receive the same v-SKY intervention as the ACT group. According to our earlier estimates, a high number of veterans with PTSD may not be actively receiving treatment for their illness. For these reasons, a waitlist control design may better reflect the current treatment environment for veterans with PTSD.

Interventions

Sudarshan Kriya Yoga (SKY)

This is the experimental arm of the study, where participants will be trained in a form of breathing based meditation that incorporates different breathing techniques centred around controlling arousal and attention. Participants will be encouraged to learn all of the techniques that are covered during these sessions and also utilize the techniques that are most appropriate for their personal needs. After some initial training sessions, participants will be encouraged to practice their new SKY techniques in environments and situations that they have been avoiding. They would begin with situations that are less triggering, and progress to more difficult situations. At each group session, participants will describe their experiences and discuss ways to continue to incorporate the SKY techniques into their daily lives, until it reaches a point of being natural to use these skills throughout the day, both in practice, and in application.

Primary outcome measure

  • Change in PTSD symptoms [ Time Frame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30) ]

Central Contacts and Locations

Central contacts

Jessica Hajj

647-804-6121jessica.hajj@sinaihealth.ca

Locations

Sinai Health

Recruiting

Toronto, Ontario, Canada, M4M 2B5

Contacts

Jessica Hajj

647-804-6121jessica.hajj@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Mar 16, 2023

Last verified

Mar, 2023

Keywords

  • Veteran
  • Armed forces
  • Royal Canadian Mounted Police
  • RCMP
  • Meditation
  • Sudarshan Kriya Yoga
  • Breathing-based meditation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2023-03-16.