Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial

Contemp Clin Trials. 2022 Jun;117:106768. doi: 10.1016/j.cct.2022.106768. Epub 2022 Apr 22.


Introduction: The COVID-19 pandemic has placed health care workers at unprecedented risk of stress, burnout, and moral injury. This paper describes the design of an ongoing cluster randomized controlled trial to compare the effectiveness of Stress First Aid (SFA) to Usual Care (UC) in protecting the well-being of frontline health care workers.

Methods: We plan to recruit a diverse set of hospitals and health centers (eight matched pairs of hospitals and six pairs of centers), with a goal of approximately 50 HCW per health center and 170 per hospital. Participating sites in each pair are randomly assigned to SFA or UC (i.e., whatever psychosocial support is currently being received by HCW). Each site identified a leader to provide organizational support of the study; SFA sites also identified at least one champion to be trained in the intervention. Using a "train the trainer" model, champions in turn trained their peers in selected HCW teams or units to implement SFA over an eight-week period. We surveyed HCW before and after the implementation period. The primary outcomes are posttraumatic stress disorder and general psychological distress; secondary outcomes include depression and anxiety symptoms, sleep problems, social functioning problems, burnout, moral distress, and resilience. In addition, through in-depth qualitative interviews with leaders, champions, and HCW, we assessed the implementation of SFA, including acceptability, feasibility, and uptake.

Discussion: Results from this study will provide initial evidence for the application of SFA to support HCW well-being during a pandemic.

Trial registration: (Clinicaltrials.govNCT04723576).

Keywords: COVID-19; Healthcare workers; Mental health; Stress.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19* / prevention & control
  • Health Personnel
  • Humans
  • Pandemics
  • Psychological Distress*
  • Randomized Controlled Trials as Topic
  • SARS-CoV-2

Associated data