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

April 10, 2022 updated by: Akshya Vasudev, Lawson Health Research Institute

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participant recruitment
Time Frame: 1 year
The number of participants recruited per month will be calculated as a feasibility measure.
1 year
Rate of retention
Time Frame: 1 year
The retention rate of participants will be calculated as a feasibility measure.
1 year
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.
1 year
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.
1 year
Unexpected costs
Time Frame: 1 year
The total of unexpected costs will be calculated as a feasibility measure.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Week 0 to week 3 and to week 5
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).
Change from Week 0 to week 3 and to week 5
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.
Change from Week 0 to week 3 and to week 5
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).
Change from Week 0 to week 3 and to week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Art of Living Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2020

Primary Completion (ACTUAL)

April 9, 2022

Study Completion (ACTUAL)

April 9, 2022

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

April 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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