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

King's College London0 个研究点目标入组 15 人开始时间: 2020年2月28日最近更新: 2024年3月4日

适应症

试验速览

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)

•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

•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

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