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Depressive SymptomsNCT05271006

COVID-19 Research: COPE Trial in Health Care Workers

A study testing Exercise in people with Depressive Symptoms and Physical Inactivity, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms, Physical Inactivity
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
1 siteCanada
Study dates
31 Mar 2022to 16 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z4

Other trials in Canada

About this study

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

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).

Read the detailed 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.

Being tested
Exercise
Keywords
Exercise, Intervention, mhealth, Depression, Heatlh care workers
Medical subject headings
Depression, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT05271006
Study groupRoleWhat they receive
Exercise groupExperimentalWeeks 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.
Receives: Behavioral: Exercise
Waitlist control groupNo interventionWeeks 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)

  1. 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).

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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).

    Measured: Tracked weekly for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start31 Mar 2022
  3. Primary completion30 Sep 2022
  4. Study completion16 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271006
Sponsor's protocol ID
H21-02612
Status last verified
May 2023
First submitted
2 Mar 2022
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after de-identification upon request and cleared for approval by principal investigator. All of the protocols, statistical analysis plan, informed consent form, analytic code.

Publications

  • 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.

    PubMed 17762223

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

    PubMed 30107104

  • 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.

    PubMed 16618485

  • 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.

    PubMed 32202646

  • 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.

    PubMed 32295761

  • 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.

    PubMed 29256033

  • 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.

    PubMed 28838887

  • 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.

    PubMed 34580067

  • 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.

    PubMed 2748771

  • 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.

    PubMed 30307262

  • 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.

    PubMed 18696313

  • 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.

    PubMed 16367493

  • 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.

    PubMed 8037935

  • 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.

    PubMed 37556150

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Depressive Symptoms and Physical Inactivity, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in depressive symptomology over the course of the exercise intervention (time frame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271006, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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