Clinical trial NCT04368676: Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness During the COVID-19 Pandemic
Official title: Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness (BREATH): an RCT for Frontline Hospital and Long-term Care Home Staff Managing the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Job Stress
Workplace Stress
Compassion Fatigue
Psychological Trauma
Healthcare Workers
Healthcare Providers
Keywords: COVID-19
Coronavirus
Healthcare staff
Work stress
insomnia
anxiety
depression
resilience
mind-body intervention
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Art of Living Foundation
First posted: 2020-04-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of participant recruitment
timeFrame: 1 year
measure: Rate of retention
timeFrame: 1 year
measure: Completeness of data entry
timeFrame: 1 year
measure: Cost of interventions
timeFrame: 1 year
measure: Unexpected costs
timeFrame: 1 year
Secondary outcomes:
measure: Change in Athens Insomnia Scale
timeFrame: Change from Week 0 to week 3 and to week 5
measure: Change in Generalized Anxiety Disorder 7-item scale
timeFrame: Change from Week 0 to week 3 and to week 5
measure: Change in Patient Health Questionnaire 9
timeFrame: Change from Week 0 to week 3 and to week 5
measure: Change in Connor-Davidson Resilience Scale
timeFrame: Change from Week 0 to week 3 and to week 5
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
citation: Lai KSP, Watt C, Ionson E, Baruss I, Forchuk C, Sukhera J, Burhan AM, Vasudev A. Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial. Trials. 2020 Jul 14;21(1):648. doi: 10.1186/s13063-020-04583-w.
citation: Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.