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

Mount Sinai Hospital, Canada

Status: Enrolling

Conditions: Depressive Symptoms; Post Traumatic Stress Disorder; Quality of Life; PTSD; Anxiety; Pain

Treatments: Behavioral: Sudarshan Kriya Yoga (SKY)

Study type: Interventional

Funder types: Other

Identifiers

NCT05235828

21-0275-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Active intervention (ACT) group

Experimental group

Description:

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.

Treatment:

Behavioral: Sudarshan Kriya Yoga (SKY)

Waitlist control (WLC) group

No Intervention group

Description:

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.