ISRCTN14644379
Completed
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anorexia nervosa
- Sponsor
- South London and Maudsley NHS Foundation Trust
- Enrollment
- 380
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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