A multicentre, investigator-blinded, randomised, 18 month, parallel group, superiority study to examine whether the addition of a patient and carer shared management intervention improves patient wellbeing following inpatient treatment for anorexia nervosa

South London and Maudsley NHS Foundation Trust0 个研究点目标入组 380 人开始时间: 2016年12月8日最近更新: 2024年4月29日

适应症

试验速览

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28944595 protocol 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35856250/ Qualitative investigation (added 19/01/2023) 2024 Other publications in https://doi.org/10.1192/bjo.2023.642 qualitative study of patient and carer experiences of a hybrid online guided self-help intervention (ECHOMANTRA) (added 17/04/2024)

•Inclusion criteria as of 07/06/2017:
•1. Aged 17 or over
•2. With a DSM-5 diagnosis of Anorexia Nervosa or atypical/subclinical Anorexia Nervosa and a body mass index (BMI) of < 18.5 kg/m2
•3. With a carer willing to participate. A broad definition of carer” will be used to include family and/or friends willing and able to provide some aftercare support
•4. Consent form signed within 2 months from admission
•5. Participants able to access an electronic device (e.g. mobile phone, computer, laptop, tablet) and the internet in order to use the study’s website)
•Original inclusion criteria:
•1. Consecutive admissions for in/day patient care
•2. Aged 17 or over
•3. DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of < 18.5 kg/m2
•4. With a carer willing to participate. We will use a broad definition of carer” to include family and/or friends willing and able to provide some aftercare support
•5. Informed consent signed within 1 month from admission
•5. Participants able to access an electronic device (e.g. mobile phone, computer, laptop, tablet) and the internet in order to use the study’s website

•Exclusion criteria as of 07/06/2017:
•1. The patient is not admitted for inpatient care or is not attending daycare for a minimum of 4 days/week at the time of consenting
•2. The patient has an insufficient knowledge of English
•3. The patient has severe mental or chronic physical illness needing treatment in its own right (e.g. psychosis, diabetes mellitus, cystic fibrosis etc)
•4. The patient is pregnant
•5. The patient-carer dyad has previously received treatments involving the ECHOMANTRA materials (e.g. as part of iMANTRA trial or CASIS study)
•Original exclusion criteria:
•1. The patient has an insufficient knowledge of English
•2. The patient has severe mental or chronic physical illness needing treatment in its own right (e.g. psychosis, diabetes mellitus, cystic fibrosis etc)
•3. The patient is pregnant
•4. The dyad has previously received treatments involving the ECHOMANTRA materials (e.g. as part of the iMANTRA trial or the CASIS study)

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