COVID-19 Research: COPE Trial in Health Care Workers

NCT05271006 | Completed

• 1 other identifier: H21-02612
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Depressive Symptoms; Physical Inactivity

Keywords

Exercise; Intervention; mhealth; Depression; Heatlh care workers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.

  Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).

• Changes in flourishing over the course of the exercise intervention

  Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)

• Changes in life satisfaction over the course of the exercise intervention

  Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)

• Changes in burnout as measured by the MBI-GU over the course of the exercise intervention

  Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)

• Changes in resilience as measured by the BRS over the course of the exercise intervention

  Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)

Study Arms (2)

Exercise group

EXPERIMENTAL

Weeks 1 - 12: * For the duration of the study, participant will be completing any of the physical activities customizable within the Down Dog apps. He/she will be asked to complete a minimum of four 20-minute workouts per week. * Every two weeks, participant will receive a survey to complete. Week 24: * At week 24 (12 weeks after their initial 12-week participation in the study), participant will receive a check-in email with the final survey to complete. * Investigators will also record the use of the apps at week 24.

Behavioral: Exercise

Waitlist control group

NO INTERVENTION

Weeks 1 - 12: * For the 12 weeks of the study, participant will be asked to continue their typical, pre-study daily and weekly routine, maintaining the physical activity he/she was completing before the start of the study. * Every two weeks, the participant will receive a survey to complete. Week 24: • At the end of the first 12 weeks that he/she have access to the suite of apps (i.e., 24 weeks following their randomization to the waitlist control group), participant will receive a check-in email with the final survey to complete.

Interventions

Exercise BEHAVIORAL

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.

Exercise group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Providence Health & Services: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

Location

Related Publications (14)

• 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.

  PMID: 17762223 BACKGROUND

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

  PMID: 30107104 BACKGROUND

• 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.

  PMID: 16618485 BACKGROUND

• 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.

  PMID: 32202646 BACKGROUND

• 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.

  PMID: 32295761 BACKGROUND

• 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.

  PMID: 29256033 BACKGROUND

• 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.

  PMID: 28838887 BACKGROUND

• 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.

  PMID: 34580067 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 30307262 BACKGROUND

• 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.

  PMID: 18696313 BACKGROUND

• 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.

  PMID: 16367493 BACKGROUND

• 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.

  PMID: 8037935 BACKGROUND

• Boucher VG, Haight BL, Hives BA, Zumbo BD, Merali-Dewji A, Hutton S, Liu Y, Nguyen S, Beauchamp MR, Black AT, Puterman E. Effects of 12 Weeks of At-Home, Application-Based Exercise on Health Care Workers' Depressive Symptoms, Burnout, and Absenteeism: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1101-1109. doi: 10.1001/jamapsychiatry.2023.2706.

  PMID: 37556150 DERIVED

MeSH Terms

Conditions

Depression; Sedentary Behavior; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eli Puterman, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI will be blind to the allocation to the groups. Person sending out emails to participants to complete surveys will be blind to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Power analysis with three different effect sizes δ: .30, .40, and .50. Using Optimal Design Software, to detect a small effect size δ= .30 based on a two-level (non)linear growth model (six time points; level-1 residual variability = 8.798; level-1 coefficient variability = 22.548) with Power (1 - b) = .80 and alpha = .05 for 7 time points repeated measures design, 357 participants required across the four arms. With an additional 10 recruitment sites, investigators require an additional 90 participants (for the possibility of nesting or for creation of 9 dummy variables to covary locations). With a 20% expected attrition, a total of 560 HCWs will be randomized. Investigators will be employing this conservative target for this study. In order to detect a small effect size δ= .40 and a 20% expected attrition, a total of 366 HCWs will be randomized. In order to detect a small effect size δ= .50 and a 20% expected attrition, a total of 276 HCWs will be randomized.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 8, 2022
• Study Start: March 31, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 16, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 4 months following trial's end, materials will be made available. following publication, all data will be made available.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for the purpose for the purpose of meta-analyses and to achieve aims in the approved proposal. Investigators of the study need to approve the proposals. Proposals should be directed to eli.puterman@ubc.ca.

Locations

CA (1)