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

NCT04368676 | Terminated Early Phase 1

• 1 other identifier: 115855
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Job Stress; Workplace Stress; Compassion Fatigue; Psychological Trauma; Healthcare Workers; Healthcare Providers

Keywords

COVID-19; Coronavirus; Healthcare staff; Work stress; insomnia; anxiety; depression; resilience; mind-body intervention

Outcome Measures

Primary Outcomes (5)

• Rate of participant recruitment

  The number of participants recruited per month will be calculated as a feasibility measure.

  1 year

• Rate of retention

  The retention rate of participants will be calculated as a feasibility measure.

  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.

  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.

  1 year

• Unexpected costs

  The total of unexpected costs will be calculated as a feasibility measure.

  1 year

Secondary Outcomes (4)

• Change in Athens Insomnia Scale

  Change from Week 0 to week 3 and to week 5

• Change in Generalized Anxiety Disorder 7-item scale

  Change from Week 0 to week 3 and to week 5

• Change in Patient Health Questionnaire 9

  Change from Week 0 to week 3 and to week 5

• Change in Connor-Davidson Resilience Scale

  Change from Week 0 to week 3 and to week 5

Study Arms (2)

Sudarshan Kroya Yoga (SKY)

EXPERIMENTAL

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)

Health Enhancement Program (HEP)

ACTIVE COMPARATOR

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

Interventions

Sudarshan Kriya Yoga (SKY) OTHER

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.

Sudarshan Kroya Yoga (SKY)

Health Enhancement Program OTHER

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.

Health Enhancement Program (HEP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants will be aged 18 to 70.
• 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
• Have sufficient hearing to follow verbal instructions.
• Have an adequate understanding of English.
• Able to sit without physical discomfort for 60 minutes.
• Not pregnant and willing to remain not pregnant for the duration of the study.

You may not qualify if:

• Inability to independently provide informed consent.
• Current suicidality as assessed by the suicide item of the Patient Health Questionnaire-9 scale.
• History of bipolar disorder.
• History of chronic PTSD.
• History of schizophrenia or schizoaffective disorder.
• Currently practice any type of formal meditation, mindfulness, or breathing techniques regularly (greater than 3 times per week).
• History of complex PTSD.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Art of Living Foundation: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• Lai KSP, Watt C, Ionson E, Baruss I, Forchuk C, Sukhera J, Burhan AM, Vasudev A. Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial. Trials. 2020 Jul 14;21(1):648. doi: 10.1186/s13063-020-04583-w.

  PMID: 32665041 DERIVED

• Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

  PMID: 32627860 DERIVED

MeSH Terms

Conditions

Occupational Stress; Compassion Fatigue; Psychological Trauma; COVID-19; Coronavirus Infections; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the treatment hypothesis while the data analyst will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 30, 2020
• Study Start: June 25, 2020
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)