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

Roberto Mediavilla; Kerry R McGreevy; Mireia Felez-Nobrega; Anna Monistrol-Mula; María-Fe Bravo-Ortiz; Carmen Bayón; Beatriz Rodríguez-Vega; Pablo Nicaise; Audrey Delaire; Marit Sijbrandij; Anke B Witteveen; Marianna Purgato; Corrado Barbui; Federico Tedeschi; Maria Melchior; Judith van der Waerden; David McDaid; A-La Park; Raffael Kalisch; Papoula Petri-Romão; James Underhill; Richard A Bryant; Josep Maria Haro; José Luis Ayuso-Mateos; RESPOND Consortium

doi:10.1177/20552076221129084

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

Digit Health. 2022 Oct 5:8:20552076221129084. doi: 10.1177/20552076221129084. eCollection 2022 Jan-Dec.

Authors

Roberto Mediavilla^{1

2}, Kerry R McGreevy^{1

2}, Mireia Felez-Nobrega^{2

3}, Anna Monistrol-Mula³, María-Fe Bravo-Ortiz^{1

2

4

5}, Carmen Bayón^{1

2

4

5}, Beatriz Rodríguez-Vega^{1

2

4

5}, Pablo Nicaise⁶, Audrey Delaire⁶, Marit Sijbrandij⁷, Anke B Witteveen⁷, Marianna Purgato⁸, Corrado Barbui⁸, Federico Tedeschi⁸, Maria Melchior⁹, Judith van der Waerden⁹, David McDaid¹⁰, A-La Park¹⁰, Raffael Kalisch^{11

12}, Papoula Petri-Romão¹¹, James Underhill¹³, Richard A Bryant¹⁴, Josep Maria Haro^{2

3}, José Luis Ayuso-Mateos^{1

2

15}; RESPOND Consortium

Affiliations

¹ Department of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain.
² Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain.
³ Research and Development Unit, Parc Sanitari Sant Joan de Déu, Barcelona, Spain.
⁴ Department of Psychiatry, Clinical Psychology and Mental Health, Hospital Univeristario La Paz, Madrid, Spain.
⁵ Instituto de Investigación del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
⁶ Institute of Health & Society (IRSS), Université Catholique de Louvain, Brussels, Belgium.
⁷ Clinical, Neuro- and Developmental Psychology, WHO Collaborating Centre for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
⁸ WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
⁹ Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Equipe de Recherche en Epidémiologie Sociale (ERES), Faculté de Médecine St Antoine, , Paris, France.
¹⁰ Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.
¹¹ Leibniz Institute for Resilience Research (LIR), Mainz, Germany.
¹² Neuroimaging Center (NIC), Focus Program Translational Neuroscience (FTN), Johannes Gutenberg University Medical Center, Mainz, Germany.
¹³ Research consultant, Brighton, UK.
¹⁴ School of Psychology, University of New South Wales, Sydney, NSW, Australia.
¹⁵ Department of Psychiatry, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain.

Abstract

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.

Keywords: MeSH terms; adjustment disorders; analysis; anxiety; coronavirus disease 2019; cost; depression; healthcare facilities; internet-based intervention; psychological; psychological distress; psychosocial intervention; resilience; workforce and services.

Associated data

ClinicalTrials.gov/NCT04980326