Binge eating disorder Mental and Behavioural Disorders
Conditions
Interventions
Participants will be allocated to one of the trial arms using a 1:1 allocation ratio. Randomization will be conducted through a validated online system, Sortition, developed by the University of Oxfor
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Participant provides informed consent for participation in the study 2. Aged 18 years or above (of any gender) 3. Recurrent objective binge eating for 3 months or more 4. Able to read and write in English
Exclusion criteria
Exclusion criteria: 1. Any self-induced vomiting or laxative misuse over the past 28 days 2. Severe low weight (<18.5 kg/m2) 3. Co-occurring condition or treatment which could interfere with day-to-day eating 4. Pregnancy 5. Severe depression 6. Suicidal or self-harm thoughts 7. Problem with substance misuse 8. Currently receiving (or waiting for) treatment for binge eating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to assess the feasibility and acceptability of a future definitive randomised controlled trial (RCT) evaluating the clinical and cost-effectiveness of a Digital Guided Self-Help programme with waitlist control for adults with binge eating disorders (BED). This will help to inform planning for a fully powered trial. Its primary outcomes are the feasibility of key trial components: 1. Recruitment: effectiveness and acceptability of the recruitment process assessed by evaluating how well the recruitment process identifies eligible participants, attracts willing participants and includes a diverse demographic range. This would include describing the number of participants identified through advertisements, approached based on initial screening, consented during recruitment, randomised after recruitment and completed end-of-treatment and follow-up assessments (12 and 24 weeks post-randomisation) 2. Outcomes: the meaningfulness of outcomes for a future trial evaluated by assessing the participants' perceived relevance and value of those selected via qualitative interviews at 12 weeks post-randomisation 3. Assessments: the acceptability of outcome measures (concerning completion rates and perceived burden via qualitative interviews) at 12 weeks post-randomisation 4. Treatment: the acceptability of the treatment assessed via qualitative interviews and rates of adherence (during the intervention) and completion at 12 weeks post-randomisation 5. PPI: future trial PPI refining by seeking feedback and reviewing the process at the end of the study (after write-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, end-of-treatment, and 12-week follow-up: 1. Binge eating frequency, measured using the Eating Disorder Examination Questionnaire (EDE-Q) 2. Severity of general eating disorder features measured using the Eating Disorder Examination Questionnaire (EDE-Q) 3. Severity of secondary psychosocial impairment, measured using Clinical Impairment Assessment (CIA) 4. Severity of depressive features, measured using Patient Health Questionnaire (PHQ-9) 5. Self-reported productivity & healthcare costs, measured using a bespoke Costs & Resources Measure 6. Harms & adverse effects of intervention, measured using a bespoke intervention questionnaire | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca Murphy
Outcome results
None listed