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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
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.
- Rate of participant recruitment [ Time Frame: 1 year ]The number of participants recruited per month will be calculated as a feasibility measure.
- Rate of retention [ Time Frame: 1 year ]The retention rate of participants will be calculated as a feasibility measure.
- 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.
- 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.
- Unexpected costs [ Time Frame: 1 year ]The total of unexpected costs will be calculated as a feasibility measure.
- 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 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 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 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).
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
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5W9|