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

Antoni Grau Touriño, Guillem Feixas, Joan Carles Medina, Clara Paz, Chris Evans, Antoni Grau Touriño, Guillem Feixas, Joan Carles Medina, Clara Paz, Chris Evans

Abstract

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.

Keywords: adult psychiatry; child & adolescent psychiatry; clinical audit; eating disorders; protocols & guidelines; quality in health care.

Conflict of interest statement

Competing interests: AGT is the Clinical Director at ITA Mental Health, the network financing the study and in which it is being conducted. ITA was motivated to explore the effectiveness and any differential effectiveness of the treatment programme by centre, hence, funded data collection within ITA and also funded an external organisation, University of Barcelona, to deliver scientific advice in the design and implementation of data collection, to ensure database integrity, and to ensure independent analysis. The data collection has generated a pseudonymised dataset which is held by UB and CE. ITA Mental Health and the University of Barcelona (team led by GF) have established a contract for this collaboration (ref. FBG309562). GF is the Principal Investigator of the research group involved in this contract.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schedule for data collection and assessments for a 12-month treatment. This table represents an example of data collection and assessment for patients within the service for 1 year. Data collection beyond that point continues as it was in the first year until the termination of intensive data collection in October 2020. From November 2020 to end of October 2025, CORE-OM and EAT-26 (or ChEAT-26) will be administered every 3 months. BITE, Bulimic Investigatory Test of Edinburgh; ChEAT-26, Children’s Eating Attitudes Test; CORE-OM, Clinical Outcomes in Routine Evaluation-Outcome Measure; CORE-SFA, Clinical Outcome in Routine Evaluation Short Form A; CORE-SFB, Clinical Outcome in Routine Evaluation Short Form B; EAT-26, Eating Attitudes Test; W1/2, Week 1/2; M3/6/9/12, month 3/6/9/12 from time 0; YP-CORE, Young Person’s CORE.

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