TY - JOUR
T1 - Effectiveness of a stepped-care programme of internet-based psychological interventions for healthcare workers with psychological distress
T2 - Study protocol for the RESPOND healthcare workers randomised controlled trial
AU - on behalf of the RESPOND Consortium
AU - Mediavilla, Roberto
AU - McGreevy, Kerry R.
AU - Felez-Nobrega, Mireia
AU - Monistrol-Mula, Anna
AU - Bravo-Ortiz, María Fe
AU - Bayón, Carmen
AU - Rodríguez-Vega, Beatriz
AU - Nicaise, Pablo
AU - Delaire, Audrey
AU - Sijbrandij, Marit
AU - Witteveen, Anke B.
AU - Purgato, Marianna
AU - Barbui, Corrado
AU - Tedeschi, Federico
AU - Melchior, Maria
AU - van der Waerden, Judith
AU - McDaid, David
AU - Park, A. La
AU - Kalisch, Raffael
AU - Petri-Romão, Papoula
AU - Underhill, James
AU - Bryant, Richard A.
AU - Haro, Josep Maria
AU - Ayuso-Mateos, José Luis
N1 - Funding Information: The RESPOND project was funded under Horizon 2020 -the Framework Programme for Research and Innovation (2014–2020) (grant number: 101016127), and the work of MF-N was supported by a postdoctoral fellowship of the ISCIII (CD20/00036). Publisher Copyright: © The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - MeSH terms
KW - adjustment disorders
KW - analysis
KW - anxiety
KW - coronavirus disease 2019
KW - cost
KW - depression
KW - healthcare facilities
KW - internet-based intervention
KW - psychological
KW - psychological distress
KW - psychosocial intervention
KW - resilience
KW - workforce and services
UR - http://www.scopus.com/inward/record.url?scp=85139702584&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85139702584&partnerID=8YFLogxK
U2 - https://doi.org/10.1177/20552076221129084
DO - https://doi.org/10.1177/20552076221129084
M3 - Article
C2 - 36211795
SN - 2055-2076
VL - 8
SP - 1
EP - 15
JO - Digital health
JF - Digital health
ER -