Effectiveness of integrated treatment for eating disorders in Spain: protocol for a multicentre, naturalistic, observational study

INTRODUCTION: Eating disorders (EDs) are complex pathologies which require equally complex treatment strategies. These strategies should be multidisciplinary, personalised interventions, performed in appropriate settings along a healthcare continuum from inpatient to community care. Personalisation, and the complexity of levels of care and interventions make evaluation of treatments difficult. The present study aims to measure the effectiveness of a complex treatment programme for EDs which includes hospitalisation, day hospital and outpatient settings. Our purpose is to assess the complete therapeutic process of each patient through all these levels of care, capturing the multiplicity of trajectories that a programme of these characteristics involves. METHODS AND ANALYSIS: This protocol describes a multicentre, naturalistic, observational study. All patients starting between November 2017 and October 2020 in a healthcare network for EDs in Spain are being invited to participate. The first phase of intensive change monitoring to November 2020 is followed by lower intensity follow-up until October 2025. In the first phase progress of all participants is assessed every 3 weeks using specific measures for ED and the Clinical Outcomes Routine Evaluation system, a family of instruments specifically designed to measure change in psychotherapy. In the second phase data collection will happen quarterly. Both cross-sectional and longitudinal analyses will be conducted, with a special focus on patterns and predictors of change studied through multilevel linear models. ETHICS AND DISSEMINATION: The study has been approved by the Research Bioethics Committee of the University of Barcelona (no. IRB00003099) and the ethical committee of ITA Mental Health, the organisation to which all participating centres belong. Dissemination will be in papers for peer-reviewed research journals and to clinicians working with ED. TRIAL REGISTRATION NUMBER: NCT04127214.