Anorexia nervosa Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
Current intervention as of 23/10/2020:
The researchers will start by assessing their ability to recruit participants (internal pilot trial
aiming to recruit 62 patients over 4 months). If this goes well, they will then progress to the full study, which will include 386 adults (including the pilot participants) with severe AN, who are dee
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index (BMI) measured at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/08/2021: 1. Body mass index (kg/m2) measured at baseline, 6- and 24-months post-randomisation and on a monthly basis from baseline to 12-months post-randomisation 2. Eating disorder symptomology measured using the Eating Disorder Examination (EDE) Interview at baseline, 6-, and 12-months post-randomisation, the Eating Disorder Examination Questionnaire – short form (EDE-QS) at baseline, 6-, and 12-months post-randomisation and on a monthly basis from baseline to 12-months post-randomisation, and the Eating Disorder Examination Questionnaire (EDE-Q) at 24-months post-randomisation 3. Comorbid symptomology measured using the Depression, Anxiety and Stress Scales – version 21 (DASS-21) and Obsessive Compulsive Inventory-Revised (OCI-R) at baseline and 6-, 12- and 24-months post-randomisation 4. Psychosocial adjustment measured using the Clinical Impairment Assessment (CIA), the Multidimensional Scale of Perceived Social Support (MSPSS), the Work and Social Adjustment Scale (WSAS) and the UCLA Loneliness Scale - Version 3 at baseline and 6-, 12- and 24-months post-randomisation 5. Treatment motivation measured using Motivational Rulers (willingness and readiness to change) at baseline and 6-, 12- and 24-months post-randomisation 6. Treatment acceptability measured using Visual Analogue Scales of treatment acceptability at baseline and 6-, 12- and 24-months post-randomisation 7. Cost and cost-effectiveness measured using the Health-related Quality of Life (EQ-5D-5L) at 6-, 12- and 24-months post-randomisation Additional measures: 1. Autistic traits measured using the Autism Spectrum Quotient (AQ-10) at baseline 2. Treatment expectations measured using Visual Analogue Scales of treatment expectations at baseline 3. Service utilisation measured using the Adult Service Use Schedule (AD-SUS) modified for AN at baseline and 6-, 12- and 24-months post-randomisation and Hospital Episode Statistics (HES) will also be requested from N | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactBasak Ince Çaglar
Outcome results
None listed