Comparing the clinical effectiveness, acceptability and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa

Not Applicable

Completed

• Conditions: Anorexia nervosa; Mental and Behavioural Disorders

• Registration Number: ISRCTN10166784
• Lead Sponsor: King's College London

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35710394/ (added 17/06/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36952308/ (added 20/02/2024) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38109218/ (added 20/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Study Completion: 2022-08-24
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Current inclusion criteria as of 04/09/2020:
1. Adults aged 17 years and above
2. 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])
3. Body mass index (BMI) equal to or less than 16 kg/m²
4. 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
5. Have mental capacity to give informed consent to participate in the study

Previous 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

Exclusion Criteria

Current exclusion criteria as of 04/09/2020:
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).

Previous 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified