RECHARGE – A Brief Psychological Intervention to Build Resilience in Health Care Workers During the COVID-19 Pandemic: Study Protocol for a Randomized Controlled Trial

: Background: Health care workers (HCWs) typically face high work demands, which can be exacerbated during crises such as the COVID-19 pandemic. These demands may result in high psychological distress and reduced work performance. Although there are psychological interventions to reduce stress in HCWs under normal working circumstances, no intervention have been specifically developed to addresses stress in the context of public health crises such as the current COVID-19 pandemic. This study aims to evaluate the effectiveness of RECHARGE, a psychological intervention specifically developed for HCWs to reduce distress in HCWs. It is based on a brief crisis intervention of the World Health Organization that teaches basic stress management skills from cognitive behavioural therapy. Methods: A randomized controlled trial (RCT) will be carried out among 160 physicians, nurses, and other HCWs working in hospitals in Switzerland during COVID-19, who are at least moderately distressed. HCWs will be randomised to RECHARGE (n=80) or active treatment as usual (ATAU) (n=80). Pre-intervention (week 1, T1), post-intervention (week 4, T2) and 2-month follow-up (week 12, T3) assessments include psychological distress as primary outcome, and indicators of mental ill-being (worries, anxiety, depression, burnout, traumatic stress, distress due to perceived ethical dilemma) and work performance as secondary outcomes. These outcomes will be compared between HCWs in the RECHARGE and ATAU groups. Discussion: RECHARGE is an evidence-informed brief, flexible, easily scalable, fully online psychological program that allows delivery in pandemic conditions, including social isolation. Therefore, this program can serve as a much-needed template for an intervention to reduce stress and enhance work performance in HCWs during the COVID-19 pandemic. If proven effective, RECHARGE may not only be used to reduce elevated stress in HCWs in Switzerland, but also globally. Abstract 1 Background: Health care workers (HCWs) typically face high work demands, which can be 2 exacerbated during crises such as the COVID-19 pandemic. These demands may result in 3 high psychological distress and reduced work performance. Although there are psychological 4 interventions to reduce stress in HCWs under normal working circumstances, no intervention 5 have been specifically developed to addresses stress in the context of public health crises such 6 as the current COVID-19 pandemic. This study aims to evaluate the effectiveness of 7 RECHARGE, a psychological intervention specifically developed for HCWs to reduce 8 distress in HCWs. It is based on a brief crisis intervention of the World Health Organization 9 that teaches basic stress management skills from cognitive behavioural therapy. 10 Methods: A randomized controlled trial (RCT) will be carried out among 160 physicians, 11 nurses, and other HCWs working in hospitals in Switzerland during COVID-19, who are at 12 least moderately distressed. HCWs will be randomised to RECHARGE (n=80) or active 13 treatment as usual (ATAU) (n=80). Pre-intervention (week 1, T1), post-intervention (week 4, 14 T2) and 2-month follow-up (week 12, T3) assessments include psychological distress as 15 primary outcome, and indicators of mental ill-being (worries, anxiety, depression, burnout, 16 traumatic stress, distress due to perceived ethical dilemma) and work performance as 17 secondary outcomes. These outcomes will be compared between HCWs in the RECHARGE 18 and ATAU groups. 19 Discussion: RECHARGE is an evidence-informed brief, flexible, easily scalable, fully online 20 psychological program that allows delivery in pandemic conditions, including social isolation.


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high psychological distress and reduced work performance. Although there are psychological 4 interventions to reduce stress in HCWs under normal working circumstances, no intervention 5 have been specifically developed to addresses stress in the context of public health crises such 6 as the current COVID-19 pandemic. This study aims to evaluate the effectiveness of 7 RECHARGE, a psychological intervention specifically developed for HCWs to reduce 8 distress in HCWs. It is based on a brief crisis intervention of the World Health Organization 9 that teaches basic stress management skills from cognitive behavioural therapy.

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Methods: A randomized controlled trial (RCT) will be carried out among 160 physicians, 11 nurses, and other HCWs working in hospitals in Switzerland during COVID-19, who are at 12 least moderately distressed. HCWs will be randomised to RECHARGE (n=80) or active 13 treatment as usual (ATAU) (n=80). Pre-intervention (week 1, T1), post-intervention (week 4, 14 T2) and 2-month follow-up (week 12, T3) assessments include psychological distress as 15 primary outcome, and indicators of mental ill-being (worries, anxiety, depression, burnout, 16 traumatic stress, distress due to perceived ethical dilemma) and work performance as 17 secondary outcomes. These outcomes will be compared between HCWs in the RECHARGE 18 and ATAU groups.

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Discussion: RECHARGE is an evidence-informed brief, flexible, easily scalable, fully online 20 psychological program that allows delivery in pandemic conditions, including social isolation. 21 Therefore, this program can serve as a much-needed template for an intervention to reduce 22 stress and enhance work performance in HCWs during the COVID-19 pandemic. If proven 23 effective, RECHARGE may not only be used to reduce elevated stress in HCWs in 24 Switzerland, but also globally.

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Key words: randomised controlled trial,protocol,health  in times of crisis because the strategies are easy to learn and implement, transdiagnostic, and 71 address stress in otherwise healthy populations. RECHARGE was designed so that it can be 72 delivered remotely (e.g., via video-conferencing platforms) and by a range of trained 73 personnel, including those with no prior mental health qualifications (notably peers). This 74 approach was undertaken to ensure the intervention is scalable and can also be implemented  The primary aim of this study is to evaluate the effectiveness of RECHARGE to reduce 83 distress in HCWs during the COVID-19 pandemic. As secondary aim, the study explores 84 whether RECHARGE reduces symptoms of mental-health condition, and enhances work 85 performance. We will conduct an RCT comparing RECHARGE to active treatment as usual 86 (ATAU) in 160 study participants. Allocation to one of the two arms will be randomized with 87 a parallel assignment on a 1:1 basis. See Figure 1 for an overview of the design.  The primary outcome of this RCT is psychological distress as measured by the Kessler 98 Psychological Distress Scale -K-10 [12, 13] at 2-month follow-up. We hypothesise that 99 HCWs in the intervention condition (RECHARGE) demonstrate a lower level of psychological 100 distress on the K-10 at 2-month follow-up than HCWs in ATAU.

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The secondary outcomes of this RCT are mental health conditions and work performance. We 102 hypothesise that HCWs in the intervention condition demonstrate lower levels of worry, 103 anxiety, depression, burnout, posttraumatic stress, distress due to perceived ethical dilemmas, 104 4 and impaired work performance at 2-month follow-up than HCWs in ATAU. Furthermore, we 105 will compare psychological distress, mental health conditions, and work performance not only 106 at 2-month follow-up, but also immediately after the intervention and after 6 months.

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Participants 109 We will enrol 160 HCWs, who for the purpose of the study will include those who define 110 themselves as HCW (also in training) and work in a healthcare role (e.g. nurses, physicians, 111 etc.). Patient contact is no requirement to participate in this study. Participants will be 112 working in German-speaking cantons in Switzerland who meet the following eligibility same variables as at T1 will again be completed four weeks (T2), 12 weeks (two-months 156 follow up; T3), and 28 weeks (six-months follow-up; T4) after T1. Independence of 157 assessments will be guaranteed by virtue of online testing. Each participant will receive an 158 email from the trial coordinator that will contain a link to the assessment questionnaires.  198 In between the sessions, participants are asked to practise the previously taught strategies at 199 home with the help of handouts. Their progress will be reviewed during the following Coaches that will deliver RECHARGE will meet the following criteria: further part of their training, coaches are required to deliver the intervention to two mock 212 participants and be a mock participant for the intervention themselves. Adherence to the 213 RECHARGE manual will be ensured by the master trainers, who will watch a video-taped 214 intervention (i.e., all four sessions) with one of the mock participants and, using a checklist to 215 ensure basic elements of the RECHARGE intervention have been followed as required.

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Moreover, the coaches will receive one-hour weekly group supervision by the master 217 trainers, the frequency of which will be reduced gradually over the duration of the study, 218 depending on perceived competency of the coaches.

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Active Treatment-as-Usual (ATAU) 221 In the ATAU condition, HCWs will be referred to two recommended webpages that outline 222 adaptive, well-validated coping strategies for managing distress; one is from the University 223 Hospital Zurich and the other from the Mental Health Network Switzerland (Netzwerk 224 Psychische Gesundheit Schweiz) operated by the Swiss government. Participants are asked to 225 consult these webpages and follow instructions accordingly whenever they feel distressed. considered the gold standard in measuring burnout in HCWs. West and colleagues [18,19] 246 have validated a two-item screening instrument in physicians including "I feel burned out 247 from my work" and "I have become more callous toward people since I took this job" (0 = 248 never, 6 = daily), which will be used in the present study. A higher score indicates a higher 249 level of burnout. ability and productivity with seven items (e.g., "Assume that your work ability at its best has 261 a value of 10 points. How many points would you give your current work ability?" (0 = 262 completely unable to work, 10 = best work ability at present). Item 3 (disease catalogue) and 263 item 7 (mental well-being) were not included in the study. Item 7 was deemed redundant 264 because of other measurements that assess mental well-being, while the time frame used in 265 item 3 is not applicable to this study and the item was already partially integrated into one 266 exclusion criteria. A higher score indicates a higher work ability.

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All questionnaires except for the PCL-5 (past month) will be adapted to refer to the past two 268 weeks.

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Other outcomes 271 We developed other single items in order to measure: work hours ("At the moment, how All analyses will be conducted using R and SPSS software. For the RCT, both intention-to-282 treat (ITT) analysis and completers' (per protocol) analyses will be carried out. The primary 283 analysis will be the ITT analysis. Different trajectories of outcomes will be analyzed using 284 mixed linear modelling, defining treatment as fixed effects, baseline measurement of primary 285 endpoint as covariate, and subject as random effects. The benefit of this approach is that it 286 presumes intent-to-treat analyses as hierarchical linear modelling allows the number of 287 observations to vary between participants and effectively handles missing data. Time, 288 treatment condition, and their interaction will be included in the models. Baseline measures 289 (e.g. age, gender, levels of worries, depression, anxiety, etc.) will be used as covariates to 290 determine predictors of treatment response for each arm. Results will be presented as 291 differences in mean change on the K-10 (primary outcome) and on all other variables 292 (secondary outcomes) from baseline to T3 compared between RECHARGE and ATAU groups, 293 with 95% confidence intervals and p-values. In addition, differences in mean change on all 294 variables will also be calculated from baseline to T2 and T4.  Therefore, we believe that this program will deliver a much-needed template for an 319 intervention to reduce stress and enhance coping in HCWs in times of crises. RECHARGE 320 could help to ensure HCW well-being, and uphold the performance of the workforce that is 321 vital to deal with the overload posed upon the health care system by virus outbreaks.

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If proven effective, RECHARGE may not only be used in Switzerland to support the 323 response of HCWs to the current pandemic, but also globally and for other crises. In addition, 324 it may be helpful under non-pandemic circumstances within health care, or could be used as a 325 program to enhance resilience to stress in preparation of pandemics. Finally, it may be 326 13 adapted so that a variety of populations with increased psychological distress (e.g., other 327 hospital staff or individuals working in other areas) can benefit from the intervention.
328 RECHARGE may even be tested in different formats (e.g., group version).

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The study is currently recruiting and enrolling participants. Recruitment began on August 28, 332 2020, and the approximate date for completion of recruitment will be June 30, 2021.