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| Name | Class |
|---|---|
| Providence Health & Services | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Weeks 1 - 12:
Week 24:
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| Waitlist control group | No Intervention | Weeks 1 - 12:
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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Puterman, PhD | The University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T1Z4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17762223 | Background | 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. | |
| 30107104 | Background | Martin M. Physician Well-Being: Physician Burnout. FP Essent. 2018 Aug;471:11-15. |
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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.
4 months following trial's end, materials will be made available. following publication, all data will be made available.
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.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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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.
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 16618485 | 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. |
| 32202646 | 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. |
| 32295761 | 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. |
| 29256033 | 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. |
| 28838887 | 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. |
| 34580067 | 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. |
| 2748771 | 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. |
| 30307262 | 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. |
| 18696313 | 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. |
| 16367493 | 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. |
| 8037935 | 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. |
| 37556150 | Derived | 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. |