. 2022 Jun 16;23(1):500.

doi: 10.1186/s13063-022-06386-7.

The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

Madeleine Irish^#¹, Bethan Dalton^#¹, Laura Potts², Catherine McCombie³, James Shearer³, Katie Au⁴, Nikola Kern⁴, Sam Clark-Stone⁵, Frances Connan⁶, A Louise Johnston⁷, Stanimira Lazarova⁸, Shiona Macdonald⁹, Ciarán Newell¹⁰, Tayeem Pathan¹¹, Jackie Wales¹², Rebecca Cashmore¹², Sandra Marshall¹², Jon Arcelus¹³, Paul Robinson¹⁴, Hubertus Himmerich^{1

4}, Vanessa C Lawrence³, Janet Treasure^{1

4}, Sarah Byford³, Sabine Landau², Ulrike Schmidt^{15

16}

Affiliations

¹ Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
² Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
³ Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
⁴ South London and Maudsley NHS Foundation Trust, London, UK.
⁵ Gloucestershire Health and Care NHS Foundation Trust, Gloucester, UK.
⁶ Central and North West London NHS Foundation Trust, London, UK.
⁷ NHS Grampian, Aberdeen, UK.
⁸ South West London and St George's Mental Health NHS Trust, London, UK.
⁹ NHS Dumfries and Galloway, Dumfries, UK.
¹⁰ Dorset HealthCare University NHS Foundation Trust, Poole, UK.
¹¹ Surrey and Borders Partnership NHS Foundation Trust, Leatherhead, UK.
¹² Leicestershire Adult Eating Disorders Service, Leicestershire Partnership NHS Trust, Bennion Centre, Glenfield Hospital, Leicester, UK.
¹³ Institute of Mental Health, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, UK.
¹⁴ Division of Medicine, University College London, 5 University Street, London, WC1E, 6JF, UK.
¹⁵ Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. ulrike.schmidt@kcl.ac.uk.
¹⁶ South London and Maudsley NHS Foundation Trust, London, UK. ulrike.schmidt@kcl.ac.uk.

^# Contributed equally.

PMID: 35710394
PMCID: PMC9201798
DOI: 10.1186/s13063-022-06386-7

The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

Madeleine Irish et al. Trials. 2022.

. 2022 Jun 16;23(1):500.

doi: 10.1186/s13063-022-06386-7.

Authors

Affiliations

¹ Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
² Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
³ Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.
⁴ South London and Maudsley NHS Foundation Trust, London, UK.
⁵ Gloucestershire Health and Care NHS Foundation Trust, Gloucester, UK.
⁶ Central and North West London NHS Foundation Trust, London, UK.
⁷ NHS Grampian, Aberdeen, UK.
⁸ South West London and St George's Mental Health NHS Trust, London, UK.
⁹ NHS Dumfries and Galloway, Dumfries, UK.
¹⁰ Dorset HealthCare University NHS Foundation Trust, Poole, UK.
¹¹ Surrey and Borders Partnership NHS Foundation Trust, Leatherhead, UK.
¹² Leicestershire Adult Eating Disorders Service, Leicestershire Partnership NHS Trust, Bennion Centre, Glenfield Hospital, Leicester, UK.
¹³ Institute of Mental Health, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, UK.
¹⁴ Division of Medicine, University College London, 5 University Street, London, WC1E, 6JF, UK.
¹⁵ Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. ulrike.schmidt@kcl.ac.uk.
¹⁶ South London and Maudsley NHS Foundation Trust, London, UK. ulrike.schmidt@kcl.ac.uk.

^# Contributed equally.

PMID: 35710394
PMCID: PMC9201798
DOI: 10.1186/s13063-022-06386-7

Abstract

Background: Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation.

Methods: 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m² and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden.

Discussion: The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision.

Trial registration: ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Keywords: Anorexia nervosa; Day patient treatment; Inpatient treatment; Intensive treatment; Partial hospitalisation; Stepped care.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
CONSORT diagram of the DAISIES trial

See this image and copyright information in PMC

References

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