COVID-19 Research: COPE Trial in Health Care Workers

Depressive Symptoms Clinical Trial

Official title:

COvid-19 Pandemic and Exercise for Health Care Workers (COPE HCW) Trial: A Randomized Study Examining Physical Activities and Wellbeing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271006
• Other study ID #: H21-02612
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present project is designed to address the problem of elevated depression and stress among health care workers (HCWs). Investigators will test the extent to which a 12-week mobile health aerobic exercise intervention (4 days/week for 20 minutes/day) impacts HCWs reported depression. Investigators propose a 2-arm (exercise and waitlist control) parallel randomised controlled trial, with 560 underactive participants recruited from Providence Health Care. Participants will complete an online questionnaire (baseline and every 2 weeks until week 12, and again at week 24) assessing depressive symptoms (primary outcome), stress, flourishing, resilience, life satisfaction, burnout, work-family spillover, , sleep quality, workplace engagement, and absenteeism (secondary outcomes).

Description:

HCWs account for the largest sector of government employees in Canada. Regulated nurses - registered nurses, nurse practitioners, licensed practical nurses, and registered psychiatric nurses - constitute the most common HCW, with over 93% of HCWs being registered nurses across Canada. The most recent National Survey of the Work and Health of Nurses reported that compared with the average working Canadian, nurses work longer shifts, more overtime, more unpaid overtime, and have more conflict at work. Nurses also report greater stress, depression, more absenteeism, higher rates of medication use, and poorer physical health than the average employed Canadian. Shift work, high job strain and low autonomy have all been linked with decreased physical and mental health among nurses. Similarly, physicians are highly stressed and at risk for burnout and disease: 92% of physicians - including family medicine, medical specialists, and surgical specialists - work in urban areas and work more than 54 hours per week, excluding on-calls. A recent National Physician Health Survey, sampling over 2500 physicians, reported high levels of emotional exhaustion (26%), overall burnout (30%), depression (34%), and suicidal ideation (9-19%). Physicians experience more than twice as much high work stress (64% compared to 27%) as the general Canadian population. The mental health conditions reported by physicians is a direct consequence of their workload, which is physically demanding and accompanied by sleep deprivation.

To investigators knowledge, there are no studies that have used a mobile application promoting exercise to reduce the depressive symptomatology, psychological distress, and physical symptoms among HCWs in a hospital or home setting. Dr. Puterman's COVID-19 Pandemic and Exercise (COPE) trial (https://www.copetrial.ca/) is the first to study the impact of a mhealth-delivered program designed for physically distanced adults at the start of the pandemic. Results indicate significant treatment effects between those randomized to the active groups (who experienced a reduction in depressive symptoms over the 6-week period) compared to waitlist control (who remained elevated in depressive symptoms). Importantly, these effects were even more apparent in the adults with pre-randomization high levels of depression. Also, the group that was given access to both the HIIT and yoga apps had the highest adherence rates for trial completion (58%) compared to those who received access to either but not both apps (53% or 40% for yoga and HIIT, respectively). Considering the above, the purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".

The purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".

The primary objectives of this project are to test a mhealth physical activity intervention, using the "Down Dog" suite of apps, in physically less active HCWs, and to test whether the intervention leads to improvement in depressive symptomatology among those who are randomized to the intervention compared to the waitlist control group. The secondary objectives of this project are to test the intervention effects on a broader suite of mental health concepts, including stress, flourishing, resilience, life satisfaction, burnout, work-family spillover, sleep quality, and absenteeism. Thirdly, investigators seek to identify barriers and facilitators to increasing levels of physical activity during the intervention, from the perspective of stakeholders such as nurses, health service administrators, and physicians, and to determine the efficacy of the intervention, using qualitative interviews and focus group discussions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 16, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All individuals who currently do not meet recommendations for a physically active lifestyle, are over the age of 18 inclusive, who are not retired, work at a PHC centre, and are without risk factors for cardiovascular events are eligible for inclusion.

• To screen for the low active participants, investigators will use the L-CAT (see Section 9.5). All participants who score 1-3 will be included in the study. Those who score 4-6 will be excluded.

• They must also work at a Providence Health Care centre.

Exclusion Criteria:

• Participants must be cleared to participate in exercise. The 2021 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+; Section 9.5) will be used to minimize any risk of exercise and ensure the safety of individuals (Warburton, Jamnik, Bredin, Shephard, & Gledhill, 2018). Given that exercise is a risk factor for cardiovascular events, participants must report any family history of cardiovascular disease, stroke or myocardial infarction (American College of Sports Medicine, 2018). If participants do report a family history of cardiovascular events, they must receive a note from their family physician clearing them for moderate to high intensity training. If payment is required for this clearance, participants will be reimbursed.

• In addition, as informed consent requires individuals to be at least 18 years old, participants under the age of 18 will be excluded.

• Participants who are currently retired from their work or who do not currently work at a PHC centre are ineligible to participate.

• Participants without personal smartphones or computers, and those without internet service at home will be excluded.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Physical Inactivity

Intervention

Behavioral:
• Exercise
The mHealth platform to be used by the exercise group is Down Dog, which has a suite of apps for yoga, HIIT, barre, and running workouts. Down Dog has agreed to provide free memberships for one year to all participants in the study. To ensure participant de-identification on the Down Dog platform, each participant will receive a Participant ID which will be pre-registered by the study coordinator on the Down Dog platform. Randomized participants will be provided instructions for downloading the apps onto their phone or a link to the website to be used on their computer. Following randomization, participants in the exercise group will be asked to engage in physical activity (using any if the Down Dog apps), 4 days a week for 20 minutes a day for 12 weeks.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Providence Health & Services

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Cho E, Chen TY. The effects of work-family experiences on health among older workers. Psychol Aging. 2018 Nov;33(7):993-1006. doi: 10.1037/pag0000293. Epub 2018 Oct 11. — View Citation

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. — View Citation

Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007 Oct;13(5):482-8. doi: 10.1097/MCC.0b013e3282efd28a. — View Citation

Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976. — View Citation

Marjanovic Z, Greenglass ER, Coffey S. The relevance of psychosocial variables and working conditions in predicting nurses' coping strategies during the SARS crisis: an online questionnaire survey. Int J Nurs Stud. 2007 Aug;44(6):991-8. doi: 10.1016/j.ijnurstu.2006.02.012. Epub 2006 Apr 17. — View Citation

Martin M. Physician Well-Being: Physician Burnout. FP Essent. 2018 Aug;471:11-15. — View Citation

Pospos S, Young IT, Downs N, Iglewicz A, Depp C, Chen JY, Newton I, Lee K, Light GA, Zisook S. Web-Based Tools and Mobile Applications To Mitigate Burnout, Depression, and Suicidality Among Healthcare Students and Professionals: a Systematic Review. Acad Psychiatry. 2018 Feb;42(1):109-120. doi: 10.1007/s40596-017-0868-0. Epub 2017 Dec 18. — View Citation

Puterman E, Hives B, Mazara N, Grishin N, Webster J, Hutton S, Koehle MS, Liu Y, Beauchamp MR. COVID-19 Pandemic and Exercise (COPE) trial: a multigroup pragmatic randomised controlled trial examining effects of app-based at-home exercise programs on depressive symptoms. Br J Sports Med. 2022 May;56(10):546-552. doi: 10.1136/bjsports-2021-104379. Epub 2021 Sep 27. — View Citation

Rathbone AL, Prescott J. The Use of Mobile Apps and SMS Messaging as Physical and Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e295. doi: 10.2196/jmir.7740. — View Citation

Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972. — View Citation

Wu PE, Styra R, Gold WL. Mitigating the psychological effects of COVID-19 on health care workers. CMAJ. 2020 Apr 27;192(17):E459-E460. doi: 10.1503/cmaj.200519. Epub 2020 Apr 15. No abstract available. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in depressive symptomology over the course of the exercise intervention	The 10 Item Center for Epidemiologic Studies Depression Scale (CES-D) will be used in the baseline survey, and will be in each biweekly survey to track changes in the CES-D over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicating more or more frequent symptoms.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).
Secondary	Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.	The 1 Item Statistics Canada Stress Question (SCSQ) will be used in the baseline survey and in each biweekly survey to track changes in psychological stress over the study period. The SCSQ is a 1-item question with a possible scoring of 1 (Not at all stressful) to 5 (Extremely stressful).	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).
Secondary	Changes in flourishing over the course of the exercise intervention	Diener's Flourishing scale will be used in the baseline survey, and will be in each biweekly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in life satisfaction over the course of the exercise intervention	5-item Satisfaction with life scale will be used in the baseline survey, and will be in each biweekly survey to track changes in life satisfaction.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in burnout as measured by the MBI-GU over the course of the exercise intervention	The 16-item Maslach Burnout Inventory - General Use (MBI-GU) will be used in the baseline survey, and will be in each biweekly survey to track changes in burnout over the study period.; The scales of the MBI-GS provide a three-dimensional perspective on burnout. In a manner similar to the MBI-HSS, a high degree of burnout is reflected in high scores on Exhaustion and Cynicism and low scores on Professional Efficacy.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in resilience as measured by the BRS over the course of the exercise intervention	The Brief Resilience Scale (BRS) will be used in the baseline survey, and will be in each biweekly survey to track changes in resilience over the study period. The BRS uses a mean scoring system with a possible range in scores from 1-5, higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Change in work-family spillover over the course of the exercise intervention	6-item work family experience scale will be used in the baseline survey, and will be in each biweekly survey to track changes in work-family spillover over the study period.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Change in absenteeism over the course of the exercise intervention	Number of days of sick leave will be asked in the baseline survey, and will be in each biweekly survey to track changes over the study period.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Change in sleep quality over the course of the exercise intervention	1-item Pittsburgh Sleep Quality Index will be asked in the baseline survey, and will be in each biweekly survey to track sleep quality changes over the study period.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in leisure time physical activity over the course of the exercise intervention	The investigators are tracking leisure time physical activity at baseline, and biweekly (outside of the exercise intervention) using a version of the leisure score index (LSI) that was modified from the original LSI that was part of Godin's Leisure Time Exercise Questionnaire (GLTEQ). This question allows participants to tell us the frequency per week and time per exercise session of any mild, moderate, or strenuous exercise the participants have completed.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in physical health symptomology over the course of the exercise intervention	A Physical Health item will be used in the baseline and weekly surveys to track changes in physical health (e.g. headache, backache, fever, sore throat, fatigue etc.) over the course of the study period. There are 13 physical symptoms, with the scoring based on how many symptoms were experienced in the past week. The scoring range is 0-13, with higher numbers indicating experiencing more negative physical health symptoms.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Tracking the amount of exercise variety	Using the Perceived Variety in Exercise (PVE) questionnaire, the investigators are tracking how varied participants feel their exercise activities are. There are 5 items asking about exercise variety, scored 1 (false) to 6 (true), with a possible score of 5-30; higher scores indicate greater perceived variety.	Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
Secondary	Changes in use of apps over the course of the exercise intervention	Examination of adherence rate for completing 4 session of 20 minutes per week using one of the apps (running, barre, yoga, HIIT).	Tracked weekly for 12 weeks