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Clinical Trials/ISRCTN14644379
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

South London and Maudsley NHS Foundation Trust0 sites380 target enrollmentDecember 8, 2016

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)

Registry
who.int
Start Date
December 8, 2016
End Date
October 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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