Studying the Effectiveness and Implementation of Sudarshan Kriya Yoga for Canadian Veterans With PTSD

NCT05235828 | Unknown

• 1 other identifier: 21-0275-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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; Post Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms

  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.

  Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)

Other Outcomes (4)

• Change in depressive symptoms

  Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)

• Change in pain symptoms

  Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)

• Change in anxiety symptoms

  Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)

Study Arms (2)

Active intervention (ACT) group

EXPERIMENTAL

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.

Behavioral: Sudarshan Kriya Yoga (SKY)

Waitlist control (WLC) group

NO INTERVENTION

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) BEHAVIORAL

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.

Active intervention (ACT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Atlas Institute for Veterans and Families: collaborator
• St. Joseph's Health Care London: collaborator
• Quebec City Operational Stress Injury Clinic: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Sinai Health

Toronto, Ontario, M4M 2B5, Canada

RECRUITING

Related Publications (9)

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

• Hoge CW, Grossman SH, Auchterlonie JL, Riviere LA, Milliken CS, Wilk JE. PTSD treatment for soldiers after combat deployment: low utilization of mental health care and reasons for dropout. Psychiatr Serv. 2014 Aug 1;65(8):997-1004. doi: 10.1176/appi.ps.201300307.

  PMID: 24788253 BACKGROUND

• Taylor SL, Hoggatt KJ, Kligler B. Complementary and Integrated Health Approaches: What Do Veterans Use and Want. J Gen Intern Med. 2019 Jul;34(7):1192-1199. doi: 10.1007/s11606-019-04862-6. Epub 2019 Apr 22.

  PMID: 31011973 BACKGROUND

• Seppala EM, Nitschke JB, Tudorascu DL, Hayes A, Goldstein MR, Nguyen DT, Perlman D, Davidson RJ. Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. J Trauma Stress. 2014 Aug;27(4):397-405. doi: 10.1002/jts.21936.

  PMID: 25158633 BACKGROUND

• Carter, J. et al. Multi-component yoga breath program for Vietnam veteran post traumatic stress disorder: randomized controlled trial. J Trauma Stress Disor Treat 2 3, (2013).

  BACKGROUND

• Mathersul DC, Tang JS, Schulz-Heik RJ, Avery TJ, Seppala EM, Bayley PJ. Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans. BMJ Open. 2019 Apr 3;9(4):e027150. doi: 10.1136/bmjopen-2018-027150.

  PMID: 30948610 BACKGROUND

• Katzman MA, Vermani M, Gerbarg PL, Brown RP, Iorio C, Davis M, Cameron C, Tsirgielis D. A multicomponent yoga-based, breath intervention program as an adjunctive treatment in patients suffering from generalized anxiety disorder with or without comorbidities. Int J Yoga. 2012 Jan;5(1):57-65. doi: 10.4103/0973-6131.91716.

  PMID: 22346068 BACKGROUND

• Hamilton-West K, Pellatt-Higgins T, Sharief F. Evaluation of a Sudarshan Kriya Yoga (SKY) based breath intervention for patients with mild-to-moderate depression and anxiety disorders. Prim Health Care Res Dev. 2019 Jun 20;20:e73. doi: 10.1017/S1463423619000045.

  PMID: 32799993 BACKGROUND

• Vasudev K, Ionson E, Inam S, Speechley M, Chaudhari S, Ghodasara S, Newman RI, Vasudev A. Sudarshan Kriya Yoga Program in Posttraumatic Stress Disorder: A Feasibility Study. Int J Yoga. 2020 Sep-Dec;13(3):239-246. doi: 10.4103/ijoy.IJOY_16_20. Epub 2020 Sep 13.

  PMID: 33343155 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross Upshur, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Abhimanyu Sud, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Hajj

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The member of the research team who is assessing outcome measures will be blinded to the randomization outcome.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician researcher

Model Details: Waitlist control design with an active intervention (ACT) and waitlist control (WLC) group. The ACT group will receive the v-SKY intervention after the baseline assessment while the WLC group will have a 6-week waitlist period. Afterwards, the WLC group will receive the v-SKY intervention while the other group will receive no intervention for 6 weeks.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: April 25, 2022
• Primary Completion: January 31, 2024
• Study Completion: July 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CA (1)