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

Pain Clinical Trial

Official title: Sudarshan Kriya Yoga for Canadian Veterans With Post-Traumatic Stress Disorder: A Nation-wide Effectiveness and Implementation Evaluation

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Pain
• Post Traumatic Stress Disorder
• PTSD
• Quality of Life
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05235828
• Study type: Interventional
• Source: Mount Sinai Hospital, Canada
• Contact: Jessica Hajj
• Phone: 647-804-6121
• Email: jessica.hajj@sinaihealth.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Completion date: July 1, 2024