Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness During the COVID-19 Pandemic

Early Phase 1

Terminated

• Conditions: Psychological Trauma; Workplace Stress; Compassion Fatigue; Job Stress; Healthcare Workers; Healthcare Providers
• Interventions: Other: Sudarshan Kriya Yoga (SKY); Other: Health Enhancement Program

• Registration Number: NCT04368676
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).

Detailed Description

The COVID-19 pandemic continues to escalate as a global health threat, leading to devastating impacts on the healthcare system. Frontline healthcare workers are dealing with increased demands and fears for their own, as well as their family's safety. Adding to the stress is the limited ability to maintain social connectedness as physical distancing measures are in place. The investigators plan to conduct an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention called Sudarshan Kriya Yoga (SKY) (n=30) versus an online control mind-body intervention called the Health Enhancement Program (HEP) (n=30) in 60 hospital and long term care frontline staff that are managing COVID-19 patients. Participants will be blinded to the treatment hypothesis while data analyst will be blinded to treatment allocation. Both SKY and HEP will be taught online in two phases in the first week followed by weekly reinforcement sessions for the following 4 weeks. Feasibility measures will be assessed as well as self-rated measures of insomnia, anxiety, depression, and resilience. The investigators expect that it will be feasible to conduct an online RCT of two mind-body interventions, SKY and HEP, in staff managing the COVID-19 pandemic, and that the investigators will be able to remotely monitor safety and efficacy of these interventions.

Study Timeline

• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Study Start: 2020-06-25
• Status Verified: 2022-04
• Primary Completion: 2022-04-09
• Study Completion: 2022-04-09
• Last Update Submitted: 2022-04-10
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Participants will be frontline hospital or long-term care home staff involved in the management of COVID-19 patients in Canada or The United States of America.
2. Participants will be aged 18 to 70.
3. Participants will be willing and able to attend, via WebEx software, the introductory phase of SKY or HEP, as well as at least two of the four weekly follow-up sessions
4. Have sufficient hearing to follow verbal instructions.
5. Have an adequate understanding of English.
6. Able to sit without physical discomfort for 60 minutes.
7. Not pregnant and willing to remain not pregnant for the duration of the study.

Exclusion Criteria

1. Inability to independently provide informed consent.
2. Current suicidality as assessed by the suicide item of the Patient Health Questionnaire-9 scale.
3. History of bipolar disorder.
4. History of chronic PTSD.
5. History of schizophrenia or schizoaffective disorder.
6. Currently practice any type of formal meditation, mindfulness, or breathing techniques regularly (greater than 3 times per week).
7. History of complex PTSD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sudarshan Kroya Yoga (SKY)	Sudarshan Kriya Yoga (SKY)	Sudarshan Kriya Yoga (SKY) will be delivered using the Hospital approved Cisco WebEx platform. The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 10.5 hours. This includes 3 interactive online sessions of 2.5 hours each during the first week followed by four weekly follow-up sessions each 30-45 minutes long. For ease of scheduling, multiple time windows will be offered.
Health Enhancement Program (HEP)	Health Enhancement Program	The Health Enhancement Program (HEP) will be delivered using the Hospital approved Cisco WebEx platform. The online version of HEP for healthcare workers has a total duration of 10.5 hours. This includes 3 interactive online sessions of 2.5 hours each during the first week followed by four weekly follow-up sessions each 30-45 minutes long. For ease of scheduling, multiple time windows will be offered. HEP will be taught by Dr. Paris Lai, co-investigator and senior psychiatry resident.

Primary Outcome Measures

Name	Time	Method
Rate of participant recruitment	1 year	The number of participants recruited per month will be calculated as a feasibility measure.
Completeness of data entry	1 year	The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms.
Rate of retention	1 year	The retention rate of participants will be calculated as a feasibility measure.
Cost of interventions	1 year	The cost of both study interventions will be calculated to assess the total study cost for interventions and the cost per participant. This information will be used as a feasibility measure.
Unexpected costs	1 year	The total of unexpected costs will be calculated as a feasibility measure.

Secondary Outcome Measures

Name	Time	Method
Change in Athens Insomnia Scale	Change from Week 0 to week 3 and to week 5	The Athens Insomnia Scale will be used to assess insomnia. This scale is an 8-item, self-rated measure of the extent of sleep difficulties over the last 30 days with each item representing a different aspect of sleep (e.g. "Overall Quality of Sleep"). Ratings are from 0 to 4, with 0 being no difficulty with the item and 4 being the most difficulty with the item. Higher overall scores on this scale indicate higher difficulties with sleep.
Change in Patient Health Questionnaire 9	Change from Week 0 to week 3 and to week 5	The Patient Health Questionnaire (PHQ-9) is a 9-item, self-rated measure of depression which has been validated for screening a major depressive episode in adults. Total scores indicate various levels of depression: 0-4, no depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.
Change in Connor-Davidson Resilience Scale	Change from Week 0 to week 3 and to week 5	The Connor-Davidson Resilience Scale (CD-RISC) is a brief self-rated assessment tool that comprises of 10 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Higher scores reflect greater resilience, which is a measure of one's ability to cope with stress. The scale demonstrated strong reliability and validity and has been studied in a variety of populations including medical personnel, nurses, social workers and physicians).
Change in Generalized Anxiety Disorder 7-item scale	Change from Week 0 to week 3 and to week 5	The Generalized Anxiety Disorder 7-item scale (each scored 0-3) is a self-rated measure of anxiety and has been validated for the diagnosis of Generalized Anxiety Disorder in the adult population. Scores range from 0 to 21. Higher scores indicate greater anxiety symptoms (5-9, mild anxiety; 10-14, moderate anxiety; 15-21 severe anxiety).

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada