DAISIES trial
Research type
Research Study
Full 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
IRAS ID
272903
Contact name
Ulrike Schmidt
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN10166784
Duration of Study in the UK
4 years, 3 months, 31 days
Research summary
Anorexia Nervosa (AN) is a disabling and deadly disorder. About 20-30% of patients with AN need intensive treatment (either day patient or inpatient treatment) to achieve improvements or recovery. We do not know whether these two intensive treatment approaches have advantages/disadvantages for patients, families, the NHS and wider society.
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.
We will start by assessing our ability to recruit participants (internal pilot trial; aiming to recruit 62 patients over 4 months). If this goes well, we 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. The most important clinical outcome will be body mass index (BMI) at 12-months after randomisation. We will test whether stepped care is no worse than inpatient treatment (a ‘non-inferiority’ study design). We 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, we will evaluate treatment acceptability and participants’ treatment experience (using both qualitative [interviews] and quantitative methods [questionnaires]). Finally, we 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.REC name
Wales REC 5
REC reference
20/WA/0072
Date of REC Opinion
14 Apr 2020
REC opinion
Further Information Favourable Opinion