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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
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.
HEP 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.
London Health Sciences Centre
London, Ontario, Canada
Rate of participant recruitment
The number of participants recruited per month will be calculated as a feasibility measure.
Time frame: 1 year
Rate of retention
The retention rate of participants will be calculated as a feasibility measure.
Time frame: 1 year
Completeness of data entry
The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms.
Time frame: 1 year
Cost of interventions
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.
Time frame: 1 year
Unexpected costs
The total of unexpected costs will be calculated as a feasibility measure.
Time frame: 1 year
Change in Athens Insomnia Scale
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.
Time frame: Change from Week 0 to week 3 and to week 5
Change in Generalized Anxiety Disorder 7-item scale
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).
Time frame: Change from Week 0 to week 3 and to week 5
Change in Patient Health Questionnaire 9
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.
Time frame: Change from Week 0 to week 3 and to week 5
Change in Connor-Davidson Resilience Scale
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).
Time frame: Change from Week 0 to week 3 and to week 5
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