SADIE: a longitudinal Survey on Anxiety, Depression, Internalising and Externalising symptoms in Italian university students - a study protocol.

Andrea Marchi, Nicola Meda, Susanna Pardini, Irene Slongo, Francesco Visioli, Alexandru Banescu, Pasquale Caponnetto, Francesco Casadei, Marco Colizzi, Pietro Costanza, Alessandro Cuomo, Giorgia Dalla Libera, Pasquale De Fazio, Andrea Fagiolini, Ada Farinato, David Carlo Gagliano, Alessandra Galmonte, Carla Gramaglia, Sara Guidotti, Riccardo Lenti, Mirko Manchia, Giuseppe Maiello, Marco Menchetti, Alessio Maria Monteleone, Palmiero Monteleone, Andrea Pozza, Carlo Pruneti, Ciro Rizzaro, Rita Roncone, Benedetta Rigotti, Anita Zanatta, Fabio Sambataro, Caterina Novara

Journal: BMJ open 2026;16(9):e116883

PMID: 42805643

Abstract

INTRODUCTION

University students experience escalating academic, social and financial stress, resulting in high prevalence of anxiety (18%-40%), depression (12-35%) and burnout (20-30%). The COVID-19 pandemic intensified these issues, but most studies report symptom remission post-lockdown, highlighting the need for long-term prospective data on symptom trajectories and risk factors. The Survey on Anxiety, Depression, Internalising and Externalising symptoms (SADIE) study aims to (1) estimate the prevalence and incidence of anxiety, depression, burnout and suicidal ideation in Italian university students over 36 months and (2) identify modifiable psychological and behavioural predictors-such as multidimensional perfectionism, academic stress and substance use-associated with adverse symptom trajectories.

METHODS AND ANALYSES

We will recruit 5000 undergraduates and postgraduates (aged ≥18 years, fluent in Italian or English) from 14 Italian universities. Participants will complete online assessments via REDCap at baseline, 6-month, 18-month and 36-month follow-ups. Measures include demographic survey, Maslach Burnout Inventory-2, Beck Depression Inventory-II, Generalized Anxiety Disorder-7, WHO-5 Well-Being Index, Alcohol Use Disorders Identification Test-3, Cigarette Dependence Scale-5, Columbia Suicide Severity Rating Scale and Hewitt and Flett Multidimensional Perfectionism Scale. Mixed-effects models (R/lme4) and growth-mixture models will be used to evaluate symptom trajectories, while logistic regression will identify predictors of adverse outcomes. Sensitivity analyses will address potential self-selection and attrition bias.

ETHICS AND DISSEMINATION

The study has received approval from the Ethics Committee of the University of Padova (Protocol No. 235-d). Participants will provide electronic informed consent and may withdraw at any time. Risk management includes automated alerts and links to local mental health services for high-risk responses. Study findings will be disseminated through peer-reviewed publications, conference presentations and summary reports to participating institutions; deidentified data may be made available on reasonable request in line with institutional and data protection regulations.

© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

Address: Department of Medicine, University of Padua, Padua, Italy.; Department of Neuroscience, University of Padua, Padua, Veneto, Italy.; Department of General Psychology, University of Padua, Padua, Veneto, Italy.; Digital Health Research Unit, Fondazione Bruno Kessler, Trento, Italy.; Department of General Psychology, University of Padua, Padua, Veneto, Italy.; Department of Molecular Medicine, University of Padua, Padua, Veneto, Italy.; IMDEA-Nutrition, IMDEA, Madrid, Community of Madrid, Spain.; Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.; Department of Educational Sciences, Section of Psychology, University of Catania, Catania, Italy.; Department of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, Italy.; Unit of Psychiatry and Eating Disorders, Department of Medicine, University of Udine, Udine, Italy.; Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Abruzzo, Italy.; Department of Molecular Medicine, School of Medicine, University of Siena, Siena, Tuscany, Italy.; Department of Medicine, University of Udine, Udine, Italy.; Department of Health Science, University of Catanzaro, Catanzaro, Calabria, Italy.; Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Friuli-Venezia Giulia, Italy.; Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Campania, Italy.; Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Tuscany, Italy.; Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Sardegna, Italy.; Department of Experimental Medicine, University of Campania Luigi Vanvitelli, Caserta, Campania, Italy.; Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.; Department of Psychiatry, University of Campania Luigi Vanvitelli, Caserta, Italy.; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.; Department of Neuroscience, University of Padua, Padua, Veneto, Italy [email protected].
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