Condition category
Mental and Behavioural Disorders
Date applied
17/02/2020
Date assigned
28/02/2020
Last edited
28/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Anorexia nervosa is a disabling and deadly disorder. About 20-30% of patients with anorexia nervosa need intensive treatment (day patient or inpatient treatment or both) to help them improve or recover. It is not known whether either of these two intensive treatment approaches has advantages/disadvantages for patients, families, the NHS and wider society. The aim of this study is to assess the effectiveness and acceptability of these two intensive treatment approaches: (a) specialist inpatient treatment as usual, and (b) specialist day patient treatment (either immediately or, if needed, after brief inpatient treatment to medically stabilise the patient), called ‘stepped care’, and to see whether they provide value for money.

Who can participate?
People aged 17 and above with severe anorexia nervosa or a related disorder (e.g., avoidant/restrictive food intake disorder) and a body mass index (BMI) of 16kg/m2 or below, who are are in need of intensive treatment (e.g., due to illness severity, medical risk, or lack of response to outpatient psychological therapy)

What does the study involve?
After providing informed consent, participants will complete questionnaires and a clinical interview to assess eating disorder symptoms, comorbid symptoms (e.g., mood), psychosocial adjustment, quality of life, and treatment motivation and expectations. Participants will then be randomly allocated to one of the two intensive treatment approaches: inpatient treatment-as-usual or the stepped care day-patient treatment approach. Participants’ eating disorder symptoms will be monitored monthly from the first assessment to 12 months after random allocation. Participants will be asked to complete follow-up assessments (identical to the baseline assessment) at 6, 12 and 24 months after random allocation. If agreed by the patient, the researchers will also invite their main carer to complete two brief questionnaires at the start of the study and 6, 12 and 24 months later. Following the 12-month assessment, a sample of patients (20 per treatment group) and family carers (20 per treatment group) will be invited to complete a short audio-recorded qualitative interview with one of the researchers about their experiences of treatment within the study.

What are the possible benefits and risks of participating?
Both treatment approaches are effective, safe and routinely used in the NHS. The researchers expect participants to benefit in terms of improvement in eating disorder and related psychological and physical symptoms, quality of life, general well-being and relationships with close others. Additionally, many people enjoy being part of a large study such as this one, which helps answer important questions about the treatment and care given to patients in the NHS. Research assessment meetings with members of the research team (face-to-face or by phone) and the opportunity to think about their situation, progress and experiences of treatment often is also experienced as enriching by participants. This research will also enhance the evidence base on the treatment of people with severe anorexia nervosa. There may be some discomfort associated with completing questionnaires evaluating the outcome of treatment, although all the questionnaires given are very widely used and usually do not cause distress.

Where is the study run from?
King’s College London and Specialist Eating Disorder Services across the UK

When is the study starting and how long is it expected to run for?
December 2019 to July 2024

Who is funding the study?
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
Bethan Dalton
bethan.dalton@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Bethan Dalton

ORCID ID

http://orcid.org/0000-0003-0898-1926

Contact details

Trial Coordinator
PO59 Section of Eating Disorders
Institute of Psychiatry
Psychology & Neuroscience
King’s College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 0183
bethan.dalton@kcl.ac.uk

Type

Scientific

Additional contact

Prof Ulrike Schmidt

ORCID ID

http://orcid.org/0000-0003-1335-1937

Contact details

Principal Investigator
PO59 Section of Eating Disorders
Institute of Psychiatry
Psychology & Neuroscience
King’s College London
De Crespigny Park
London
SE5 8AF
United Kingdom
-
ulrike.schmidt@kcl.ac.uk

Type

Scientific

Additional contact

Ms Madeleine Irish

ORCID ID

Contact details

PO59 Section of Eating Disorders
Institute of Psychiatry
Psychology & Neuroscience
King’s College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 5608
madeleine.irish@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43945, IRAS 272903

Study information

Scientific title

A randomised controlled multi-centre open-label parallel-group non-inferiority trial of the clinical effectiveness, acceptability and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services

Acronym

DAISIES

Study hypothesis

This study aims to compare the clinical effectiveness, acceptability and cost-effectiveness of two intensive treatment approaches in routine NHS practice: specialist inpatient treatment as usual (IP-TAU) and a stepped care day treatment.

Ethics approval

Approval pending, Wales REC 5, REC ref: 20/WA/0072

Study design

Randomised; Both; Design type: Treatment, Process of Care, Psychological & Behavioural, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Anorexia nervosa

Intervention

The researchers will start by assessing their ability to recruit participants (internal pilot trial; aiming to recruit 62 patients over 4 months). If this goes well, they will then progress to the full study, which will include 386 adults (including the pilot participants) with severe AN, who are deemed to need intensive treatment. Participants will be recruited from specialist eating disorder services across the UK. After completion of a baseline assessment, patients will be allocated by chance to either stepped care day treatment or IP-TAU.

Inpatient treatment-as-usual (IP-TAU)
IP-TAU uses the current standard patient care pathway. In this care pathway, patients admitted to a specialist eating disorder inpatient unit are treated until they reach a body mass index (BMI) of 18.5 kg/m2 and normalise their eating, or get as close to this point as possible (e.g., a pre-defined BMI goal for patients with severe enduring AN). Patients admitted to IP-TAU are treated by a multidisciplinary team (including psychiatrists, psychologists, dieticians, nurses and others) and receive expert refeeding, therapeutic programmes and supervised meals and snacks. A proportion may also have day patient treatment at the end, at the discretion of the treating team.

Stepped care day patient treatment approach
This stepped care day patient treatment approach combines intensive day patient treatment with the option of inpatient treatment for medical stabilisation and progression to day patient treatment at the earliest opportunity. Regular risk assessments will be conducted with clear decision rules around patients’ suitability for stepping down into multi-disciplinary specialist day patient treatment. Day patient treatment will involve 4-5 days a week with 2-3 meals per day, multi-disciplinary support (including psychiatrists, psychologists, dieticians, nurses and others) and high-quality evidence-based psychological interventions for patients and their carers. Patients will return home for weekends and evenings. Patients who are allocated to the stepped care intervention can either start day patient treatment immediately or be stepped down to day patient treatment after a period of inpatient treatment. The main aim of the day patient treatment will be to treat patients until they reach a healthy weight and normalise their eating, or get as close to this point as possible.

The most important clinical outcome will be body mass index (BMI) at 12 months after randomisation. The researchers will test whether stepped care is no worse than inpatient treatment (a ‘non-inferiority’ study design). They will also assess a number of secondary outcomes, including eating disorder symptoms, comorbid symptoms, social functioning, quality of life, any relapses or re-admissions to hospital, as well as outcomes for carers. Additionally, they will evaluate treatment acceptability and participants’ treatment experience (using both qualitative [interviews] and quantitative methods [questionnaires]). Finally, they will look at the cost of the two different treatment approaches and explore whether day patient treatment is better value for money than inpatient treatment to the NHS.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Body mass index (BMI) measured at 12 months post-randomisation

Secondary outcome measures

1. Body mass index (kg/m2) measured at baseline, 6 and 24months post-randomisation and on a monthly basis from baseline to 12 months post-randomisation
2. Eating disorder symptomology measured using the Eating Disorder Examination (EDE) Interview at baseline, 6, 12, and 24 months post-randomisation and the Eating Disorder Examination Questionnaire – short form (EDE-QS) at baseline, 6, 12, and 24 months post-randomisation and on a monthly basis from baseline to 12 months post-randomisation
3. Comorbid symptomology measured using the Depression, Anxiety and Stress Scales – version 21 (DASS-21) and Obsessive Compulsive Inventory-Revised (OCI-R) at baseline and 6, 12 and 24 months post-randomisation
4. Psychosocial adjustment measured using the Clinical Impairment Assessment (CIA), the Significant Others Scale (SOS), the Work and Social Adjustment Scale (WSAS) and the Revised UCLA Loneliness Scale at baseline and 6, 12 and 24 months post-randomisation
5. Treatment motivation measured using Motivational Rulers (willingness and readiness to change) at baseline and 6, 12 and 24 months post-randomisation
6. Treatment expectations measured using Visual Analogue Scales at baseline
7. Treatment experience measured using Visual Analogue Scales of treatment acceptability at baseline and 6, 12 and 24 months post-randomisation, the Therapeutic Environment Scale (TESS) at 3-months post-randomisation, and the Perceived Coercion Scale (PCS) at baseline and 6 months post-randomisation
8. Cost and cost-effectiveness measured using the Health-related Quality of Life (EQ-5D-5L) and the Adult Service Use Schedule (AD-SUS) modified for AN at baseline and 6, 12 and 24 months post-randomisation
9. Hospital Episode Statistics (HES) will also be requested from NHS Digital (for participants from England) and Information Services Division (for participants from Scotland) to assess the number of hospital admission days (e.g., to A&E, specialist eating disorder units, and general psychiatric inpatient wards) in the year prior to participation in the study and 2 years post-randomisation
10. Carer burden measured using the Depression, Anxiety and Stress Scales – version 21 (DASS-21) and the Eating Disorders Symptom Impact Scale (EDSIS) at baseline and 6, 12 and 24 months post-randomisation

Overall trial start date

01/12/2019

Overall trial end date

31/07/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female adults
2. Aged 17 years and above
3. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of severe anorexia nervosa (AN) or related disorder (e.g., avoidant/restrictive food intake disorder [ARFID; where food restriction and weight loss occur in the absence of concerns about shape and weight])
4. Body mass index (BMI) of less than 16 kg/m²
5. In need for intensive treatment because of either rapid weight loss, and/or evidence of system/organ failure/medical instability and/or unsuccessful outpatient treatment
6. Have mental capacity to give informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 386; UK Sample Size: 386

Participant exclusion criteria

1. Insufficient knowledge of English to complete study assessments or understand treatment
2. Severe learning disability
3. Severe medical or psychiatric (co)morbidity (e.g. psychosis, substance dependence) needing treatment in its own right
4. Those living too far away from day-patient treatment (and where no alternative arrangements for regular attendance at day-patient treatment can be made).
5. Those who are involved in current research or have recently been involved in any research prior to recruitment

Recruitment start date

01/04/2020

Recruitment end date

30/04/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Maudsley Hospital Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

NHS Grampian
Summerfield House 2 Eday Road
Aberdeen
AB15 6RE
United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust
Stephenson House 75 Hampstead Road
London
NW1 2PL
United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
Riverside House Bridge Park Plaza Bridge Park Road
Leicester
LE4 8PQ
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
Warneford Hospital Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

South West London St George's Mental Health NHS Trust
Springfield Hospital 61 Glenburnie Road
London
SW17 7DJ
United Kingdom

Trial participating centre

Surrey And Borders Partnership NHS Foundation Trust
18 Mole Business Park Randalls Road
Leatherhead
KT22 7AD
United Kingdom

Trial participating centre

NHS Dumfries and Galloway
Grierson House The Crichton Bankend Road
Dumfries
DG1 4ZG
United Kingdom

Trial participating centre

King's College London
P059 Psychological Medicine De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

Dorset Healthcare University NHS Foundation Trust
Sentinel House 4-6 Nuffield Road Nuffield Industrial Estate
Poole
BH17 0RB
United Kingdom

Trial participating centre

2gether NHS Foundation Trust
Rikenel Montpellier
Gloucester
GL1 1LY
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

c/o Reza Razavi
Room 5.31
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Conference presentation
3. Publication on website
4. Other publication
5. Submission to regulatory authorities

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from Prof. Ulrike Schmidt (Principal Investigator, ulrike.schmidt@kcl.ac.uk) or Dr Bethan Dalton (Trial Coordinator, bethan.dalton@kcl.ac.uk).

Intention to publish date

01/07/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/02/2020: Trial's existence confirmed by the NIHR,