Binge eating disorder Mental and Behavioural Disorders Eating disorders
Conditions
Interventions
Participants will be allocated to either one of the two intervention conditions or the control condition in a randomised order. Randomisation will be performed by the clinical trials unit at the Insti
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female community-dwelling adults between 18 and 70 years of age, who are overweight or obese according to WHO criteria (BMI =25 kg/m2) 2. Full-syndrome or sub-threshold DSM-5 Binge Eating Disorder (BED) clinical criteria met
Exclusion criteria
Exclusion criteria: 1. Individuals with a significant/unstable medical or psychiatric disorders needing acute treatment in its own right (e.g., substance dependence), major psychiatric disorders (e.g., psychosis or acute suicidality) 2. Individuals taking antidepressant medication who have not been on a stable dose for at least 2 weeks 3. Individuals with a history of epileptic seizures, stroke, or brain injury, who have any implanted metal devices in the head, frequent or severe headaches or dizziness, or are pregnant or sexually active without using contraception (all contraindications to tDCS use are outlined in Brunoni et al. 2012) 4. Individuals with severe abnormalities in a blood test during the 30 days prior to participation 5. Individuals with allergies to any of the foods presented in the study 6. Individuals who smoke >10 cigarettes per day 7. Individuals who drink >3-4 units (men) or 2-3 units (women) of alcohol per day 8. A tDCS safety questionnaire will also be administered and if considered not safe to deliver tDCS, individuals will subsequently be excluded on this basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this proof-of-concept feasibility study is to establish the feasibility of adding concurrent [ABM + tDCS] to treatment as usual in a binge eating disorder patient group and acquire key information to inform the development of a large-scale randomised sham-controlled trial (RCT). In line with recommendations of Eldridge et al. (2016), the primary outcomes of the proposed feasibility study are to: 1. Establish the feasibility of conducting a large-scale RCT of [ABM and real/sham tDCS] with a wait-list control in patients with BED by assessing recruitment, attendance, and retention rates 2. Determine the feasibility of administering both ABM and tDCS simultaneously 3. Determine the best instruments for measuring outcomes in a full trial by examining the quality, completeness, and variability in the data 4. Estimate the treatment effect sizes and standard deviations for outcome measures to inform the sample size calculation for a large-scale RCT 5. Evaluate whether the treatment is operating as it is designed by analysing process measures, such as within session visual analogue scales 6. Determine whether patients with BED view [ABM and real/sham tDCS] as acceptable and credible 7. Obtain information about patients’ willingness to undergo random allocation to ABM paired with real or sham tDCS, and to the wait-list control | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Scores in the EDE-Q, specifically indicators of change in the frequency of objective binge eating episodes from baseline, post-assessment and the 4-week follow-up time points 2. Differences between pre [ABM and real/sham tDCS] VAS scores and post [ABM and real/sham tDCS] VAS scores (per each of the 6 treatment sessions and cumulatively over sessions) 3. Changes in scores on the questionnaires and performance in tasks regarding eating disorder and general psychopathology, food, hunger and craving, impulsivity, delayed gratification and inhibitory control, measured at baseline, post-assessment and the 4-week follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactGemma Gordon
Outcome results
None listed