Clinical Trials Directory

Trials / Terminated

TerminatedNCT04368676

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

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

Status
Terminated
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
15 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSudarshan Kriya Yoga (SKY)The SKY program is a standardized, easy to learn sequential breathing yoga consisting of regulated breathing techniques followed by a timed rhythmic breathing practice. Participants will learn various exercises including rhythmic breathing, gentle yoga, and guided meditation.
OTHERHealth Enhancement ProgramHEP is a structured group program designed to help participants with information and instruction how to lead a healthier life. Participants will be provided psychoeducation and support regarding healthy active living using techniques like music therapy, diet control, exercise, and monitoring these via journaling.

Timeline

Start date
2020-06-25
Primary completion
2022-04-09
Completion
2022-04-09
First posted
2020-04-30
Last updated
2022-04-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04368676. Inclusion in this directory is not an endorsement.