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

Psychological Trauma Clinical Trial

— BREATH  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04368676
• Other study ID #: 115855
• Status: Terminated
• Phase: Early Phase 1
• Start date: June 25, 2020
• Est. completion date: April 9, 2022

Study information

• Verified date: April 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compassion Fatigue
• COVID-19
• Healthcare Providers
• Healthcare Workers
• Job Stress
• Occupational Stress
• Psychological Trauma
• Workplace Stress

Intervention

Other:
• Sudarshan 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.
• Health Enhancement Program
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Art of Living Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participant recruitment	The number of participants recruited per month will be calculated as a feasibility measure.	1 year
Primary	Rate of retention	The retention rate of participants will be calculated as a feasibility measure.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	Unexpected costs	The total of unexpected costs will be calculated as a feasibility measure.	1 year
Secondary	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.	Change from Week 0 to week 3 and to week 5
Secondary	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).	Change from Week 0 to week 3 and to week 5
Secondary	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.	Change from Week 0 to week 3 and to week 5
Secondary	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).	Change from Week 0 to week 3 and to week 5