Anorexia nervosa Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
Participants are randomised to one of two groups by King’s Clinical Trials Unit based on patient body mass index and clinical service.
Intervention arm: Participants and their carers will be able to
8 online group forum sessions and up to 6 joint Skype sessions (patient-carer) with a health professional. Participants will be able to use the workbook and video-clips and to take part in 4 online gr
monthly surveys
questionnaires at 3, 6, 9, 12 and 18 months). Participants will receive a visual feedback of their scores over time, after completing some of these questionnaires. The questionnaires will be completed
weekly surveys
questionnaires 3-, 6-, 9-, 12-, and 18-month post-randomisation). Participants will receive a visual feedback of their scores over time, after completing some of these questionnaires.
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 07/06/2017: 1. Aged 17 years 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 years 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
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 4. The dyad has previously received treatments involving the ECHOMANTRA materials (e.g. as part of the iMANTRA trial or the CASIS study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' psychological wellbeing is measured using the Depression, Anxiety and Stress Scales questionnaire at baseline and 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight and height is obtained at baseline and from monthly clinical measurements at each centre, up to 18 months post-randomisation. Patient’s weight is also self-reported at baseline and on a monthly basis, up to 18 months post-randomisation 2. Patients’ psychological wellbeing measured using the Depression, Anxiety and Stress Scales questionnaire at baseline and 18 months 3. Eating disorder psychopathology is measured using the Eating Disorder Examination-Questionnaire at baseline, 12 and 18 months 4. Quality of life is measured using the EQ-5D questionnaire at baseline and 12 months 5. Importance and confidence to change is measured using visual analogue scales at baseline and 12 and 18 months 6. Social functioning is measured through the Strengths and Difficulties Questionnaire completed by carers at baseline and 12 months 7. Work and social adjustment is measured using the Work and Social Adjustment Scale at baseline and 12 and 18 months 8. Intervention cost-effectiveness is measured using the Client Service Receipt Inventory at baseline and 12 months 9. Service use/readmission rates are measured using Hospital Episode Statistics at baseline and 12 and 18 months Carer outcomes: 1. Psychological wellbeing is measured using the Depression, Anxiety and Stress Scales questionnaire at baseline and 12 and 18 months 2. Skills to cope with eating disorder behaviours is measured using the Caregiver Skills (CASK) scale at baseline and 12 and 18 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed