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

Lawson Health Research Institute

Status and phase: Terminated; Early Phase 1

Conditions: Compassion Fatigue; Healthcare Providers; Healthcare Workers; Psychological Trauma; Job Stress; Workplace Stress

Treatments: Other: Health Enhancement Program; Other: Sudarshan Kriya Yoga (SKY)

Study type: Interventional

Funder types: Other

Identifiers

NCT04368676

115855

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Sudarshan Kroya Yoga (SKY)

Experimental group

Description:

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.

Treatment:

Other: Sudarshan Kriya Yoga (SKY)

Health Enhancement Program (HEP)

Active Comparator group

Description:

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.

Treatment:

Other: Health Enhancement Program