Clinical trial NCT05235828: Studying the Effectiveness and Implementation of Sudarshan Kriya Yoga for Canadian Veterans With PTSD
Official title: Sudarshan Kriya Yoga for Canadian Veterans With Post-Traumatic Stress Disorder: A Nation-wide Effectiveness and Implementation Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Atlas Institute for Veterans and Families
name: St. Joseph's Health Care London
name: Quebec City Operational Stress Injury Clinic
name: Nova Scotia Health Authority
First posted: 2022-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 consisting of a randomized controlled trial (RCT) and a parallel implementation evaluation of Sudarshan Kriya Yoga for Canadian veterans.

OBJECTIVES:

To determine the effect of v-SKY on decreasing PTSD symptom severity, quality of life, and depressive, anxiety, and pain symptoms in Canadian veterans affected by PTSD.

To evaluate the implementation of the v-SKY intervention amongst Canadian veterans with PTSD and the health professionals, and administrators that work with veterans, by evaluating the reach, adoption, implementation, and maintenance of the intervention.

RCT RECRUITMENT AND CONSENT: Participants who are veterans of the Canadian Armed Forces (CAF) or Royal Canadian Mounted Police (RCMP) with PTSD will be recruited through various organizations and clinics across Canada. All potential participants will be provided with a consent form and given as much time as needed to consider participation. After this time, informed consent will be obtained from those interested in participating and they will be screened for eligibility by study staff.

STUDY INTERVENTION: SKY meditation is a standardized intervention that includes relaxation techniques as well as periods of group discussion. It will be taught over Zoom by trained and certified teachers from the International Association of Human Values (IAHV) and Art of Living Foundation (AOLF). Groups of 8-12 Canadian veterans will be taught the SKY intervention over a 6-week period. Raters and instructors will be blind to participant's randomization outcome. Half of the participants will receive the v-SKY intervention within 2-weeks of the baseline assessment while the other half will receive the v-SKY intervention after a 6-week waitlist period.

DATA COLLECTION: Participants will be screened for eligibility using the PTSD Checklist for DSM-5 (PCL-5) and Mini International Neuropsychiatric Interview Screen and Standard 7.0.2 (MINI). The primary outcome (PTSD symptom severity) will be evaluated using the PCL-5. Exploratory outcomes (quality of life and symptoms of depression, anxiety, and pain) will be evaluated using the Short-form 36 (SF-36), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and Brief Pain Inventory (BPI), respectively. Measures of primary and exploratory outcomes will be administered at all 4 assessment sessions and are described below:

At the baseline assessment the following information will be collected:

Intake survey that will collect demographic information on age, partial date of birth (DOB), gender, ethnicity, employment status, military and/or RCMP service status, housing type, household finances, highest level of education achieved, smoking, caffeine intake, drug and alcohol use, duration of PTSD diagnosis, and past treatment history for their PTSD. Participants will also be asked about their psychiatric history including age of first contact with services for mental illness (and which illness), history of hospital admissions and health service use.

PCL-5 \[past-week version\] CAPS-5 \[past-month version\] PHQ-9 BPI GAD-7 SF-36 Medication log collecting medication names, dosages, dosages per day, total daily dosage, and reason for use will be recorded, including vitamins and over-the-counter (OTC) medications.

During the 6-week, 12-week, and 30-week follow-up assessments the following questionnaires and measurements will be completed:

i. PCL-5, ii. PHQ-9; iii. BPI; iv. GAD-7; v. SF-36; vi. Medication log.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PTSD symptoms
timeFrame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
Secondary outcomes:
Other outcomes:
measure: Change in depressive symptoms
timeFrame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
measure: Change in pain symptoms
timeFrame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
measure: Change in anxiety symptoms
timeFrame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
measure: Change in quality of life
timeFrame: Baseline (Week 0), Follow-up 1 (Week 6), Follow-up 2 (Week 12), Follow-up 3 (Week 30)
Locations:
city: Toronto
country: Canada
facility: Sinai Health
state: Ontario
Study officials:
affiliation: Sinai Health System
name: Ross Upshur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Abhimanyu Sud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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).
citation: 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.
citation: 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.
citation: 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.
citation: 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.