Effectiveness of a stepped-care programme of internet-based psychological interventions for healthcare workers with psychological distress: Study protocol for the RESPOND healthcare workers randomised controlled trial

Mediavilla, Roberto;McGreevy, Kerry R;Felez-Nobrega, Mireia;Monistrol-Mula, Anna;Ayuso-Mateos, José Luis;et.al.
(2022) DIGITAL HEALTH — Vol. 8, p. 205520762211290 [1-15] (2022)

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Authors
  • Mediavilla, Robertoorcid-logo
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  • McGreevy, Kerry Rorcid-logo
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  • Felez-Nobrega, Mireia
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  • Monistrol-Mula, Anna
    Author
  • Nicaise, Pabloorcid-logoUCLouvain
    Author
  • Delaire, AudreyUCLouvain
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  • Ayuso-Mateos, José Luis
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  • et. al.
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Abstract
(en) BACKGROUND AND AIMS: The coronavirus disease 2019 pandemic has challenged health services worldwide, with a worsening of healthcare workers' mental health within initial pandemic hotspots. In early 2022, the Omicron variant is spreading rapidly around the world. This study explores the effectiveness and cost-effectiveness of a stepped-care programme of scalable, internet-based psychological interventions for distressed health workers on self-reported anxiety and depression symptoms. METHODS: We present the study protocol for a multicentre (two sites), parallel-group (1:1 allocation ratio), analyst-blinded, superiority, randomised controlled trial. Healthcare workers with psychological distress will be allocated either to care as usual only or to care as usual plus a stepped-care programme that includes two scalable psychological interventions developed by the World Health Organization: A guided self-help stress management guide (Doing What Matters in Times of Stress) and a five-session cognitive behavioural intervention (Problem Management Plus). All participants will receive a single-session emotional support intervention, namely psychological first aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire - Anxiety and Depression Scale summary score at 21 weeks from baseline. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, cost impact and cost-effectiveness. CONCLUSIONS: This study is the first randomised trial that combines two World Health Organization psychological interventions tailored for health workers into one stepped-care programme. Results will inform occupational and mental health prevention, treatment, and recovery strategies. REGISTRATION DETAILS: ClinicalTrials.gov Identifier: NCT04980326.
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Mediavilla, R., McGreevy, K. R., Felez-Nobrega, M., Monistrol-Mula, A., Bravo-Ortiz, M.-F., Bayón, C., Rodríguez-Vega, B., Nicaise, P., Delaire, A., Sijbrandij, M., Witteveen, A. B., Purgato, M., Barbui, C., Tedeschi, F., Melchior, M., van der Waerden, J., McDaid, D., Park, A.-L., Kalisch, R., et al. (2022). Effectiveness of a stepped-care programme of internet-based psychological interventions for healthcare workers with psychological distress: Study protocol for the RESPOND healthcare workers randomised controlled trial. DIGITAL HEALTH, 8, 205520762211290 [1-15]. https://doi.org/10.1177/20552076221129084 (Original work published 2022)