How to distinguish promotion, prevention and treatment trials in public mental health? Study protocol for the development of the VErona-LUgano Tool (VELUT)
Pim Cuijpers,
Crick Lund,
Marianna Purgato,
Ceren Acarturk,
Davide Papola,
Marit Sijbrandij,
Federico Tedeschi,
Corrado Barbui,
Wietse A Tol,
Mark J D Jordans,
Manuela Silva,
Emiliano Albanese,
Eleonora Prina,
Alden Gross,
Anna Maria Annoni
Affiliations
Pim Cuijpers
6 Department of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, The Netherlands
Crick Lund
9 Health Service and Population Research Department, Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King`s College, London, UK
Marianna Purgato
1 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
Ceren Acarturk
7 Department of Psychology, Koc University, Istanbul, Türkiye
Davide Papola
1 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
Marit Sijbrandij
6 Department of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, The Netherlands
Federico Tedeschi
1 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
Corrado Barbui
1 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
Wietse A Tol
13 Global Health Section, University of Copenhagen, Kobenhavn, Denmark
Mark J D Jordans
9 Health Service and Population Research Department, Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King`s College, London, UK
Manuela Silva
8 Lisbon Institute of Global Mental Health, NOVA University of Lisbon, Lisboa, Portugal
Emiliano Albanese
2 Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Eleonora Prina
1 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
Alden Gross
4 Johns Hopkins University Center on Aging and Health, Baltimore, Maryland, USA
Anna Maria Annoni
2 Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Introduction Promoting mental health, preventing and treating mental disorders are critically important in public health, and many randomised controlled trials (RCTs) evaluate intervention strategies for these objectives. However, distinguishing promotion from prevention and from treatment RCTs is challenging. A tool to place studies along the promotion-to-treatment continuum in mental health research does not exist, leaving it to researchers and policymakers to decide on how to classify individual RCTs, which hinders evidence synthesis.Methods and analysis We present a protocol for the development of a new tool to assist researchers in distinguishing RCTs along the promotion-to-treatment continuum. We will establish a Tool Development Group, and use the Population, Intervention, Comparison and Outcome framework to define constructs. We will generate, define, categorise and reduce the items in the tool using qualitative methods, including cognitive interviews and a Delphi exercise. Psychometric evaluation—including unidimensionality, local independence, monotonicity and item homogeneity—will include data collection, scoring, internal consistency checks and factor analysis of the tool’s indicators for available RCTs. We will use standard Cohen’s kappa statistics to assess the reliability of the tool.Ethics and dissemination This study involves data collection from the already published literature. However, this protocol has been approved by the ethics committee of the Università della Svizzera Italiana (CE 2024 04). The results of the present project will be disseminated in peer-reviewed journals and at international and national scientific meetings. Training materials for the application of the tool will also be developed and disseminated to the scientific community. The tool and all related implementation materials will be published on a website and will be freely accessible to the public.
