Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368676
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Art of Living Foundation
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute

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).

Condition or disease Intervention/treatment Phase
Job Stress Workplace Stress Compassion Fatigue Psychological Trauma Healthcare Workers Healthcare Providers Other: Sudarshan Kriya Yoga (SKY) Other: Health Enhancement Program Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Participants will be blinded to the treatment hypothesis while the data analyst will be blinded to treatment allocation.
Primary Purpose: Treatment
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
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sudarshan Kroya Yoga (SKY)
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.
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.

Active Comparator: Health Enhancement Program (HEP)
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.
Other: 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.




Primary Outcome Measures :
  1. Rate of participant recruitment [ Time Frame: 1 year ]
    The number of participants recruited per month will be calculated as a feasibility measure.

  2. Rate of retention [ Time Frame: 1 year ]
    The retention rate of participants will be calculated as a feasibility measure.

  3. Completeness of data entry [ Time Frame: 1 year ]
    The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms.

  4. Cost of interventions [ Time Frame: 1 year ]
    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.

  5. Unexpected costs [ Time Frame: 1 year ]
    The total of unexpected costs will be calculated as a feasibility measure.


Secondary Outcome Measures :
  1. Change in Athens Insomnia Scale [ Time Frame: Change from Week 0 to week 3 and to week 5 ]
    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.

  2. Change in Generalized Anxiety Disorder 7-item scale [ Time Frame: Change from Week 0 to week 3 and to week 5 ]
    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).

  3. Change in Patient Health Questionnaire 9 [ Time Frame: Change from Week 0 to week 3 and to week 5 ]
    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.

  4. Change in Connor-Davidson Resilience Scale [ Time Frame: Change from Week 0 to week 3 and to week 5 ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368676


Locations
Layout table for location information
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Art of Living Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Akshya Vasudev, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04368676    
Other Study ID Numbers: 115855
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akshya Vasudev, Lawson Health Research Institute:
COVID-19
Coronavirus
Healthcare staff
Work stress
insomnia
anxiety
depression
resilience
mind-body intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Compassion Fatigue
Occupational Stress
Psychological Trauma
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Fatigue
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Mental Fatigue
Behavioral Symptoms
Stress, Psychological
Occupational Diseases