Does concurrent self-administered transcranial direct current stimulation and attention bias modification training improve symptoms of binge eating disorder? Protocol for the TANDEM feasibility randomized controlled trial

Abstract

BackgroundBinge eating disorder (BED) is a common and disabling problem associated with impaired cognitive control. Preliminary studies show that brain-directed treatments, including transcranial direct current stimulation (tDCS) and attention bias modification training (ABMT), improve cognitive control and alleviate symptoms of BED. When combined, tDCS may enhance the effects of ABMT, and vice versa, thereby improving treatment outcomes.MethodsThis protocol describes a feasibility single-blind randomized sham-controlled trial of concurrent self-administered tDCS and ABMT in adults with BED (The TANDEM Trial). Eighty adults with BED will be randomly assigned to one of four groups: ABMT with real or sham self-administered tDCS, ABMT only, or waiting list control. In the treatment arms, participants will complete 10-sessions of their allocated intervention over 2–3 weeks. Outcomes will be assessed at baseline (T0), immediately post treatment (T1), and 6 weeks after end of treatment (T2), and at comparable timepoints for participants in the waitlist control group. Feasibility will be evaluated by assessing recruitment/retention rates and blinding success. Acceptability will be assessed quantitatively via participant ratings and qualitatively via semi-structured interviews. Episodes of binge eating at follow-up will be the primary clinical outcome and rate ratios from Poisson regression will be reported. Secondary outcomes will assess changes in ED and general psychopathology, attention bias toward high calorie foods, and executive function.DiscussionIt is hoped that data from the trial will contribute to the development of neurobiologically informed treatments for BED, provide insights into the potential use of at-home variants of tDCS, and inform the design of future large scale trials.

Concurrent self-administered transcranial direct current stimulation and attention bias modification training in binge eating disorder: feasibility randomised sham-controlled trial

“…The effect of treatment on monthly OBEs was modelled with a generalised linear model, with a negative binomial distribution and log link. In our protocol, 33 we indicated that this relationship would be modelled with a Poisson distribution; however, due to overdispersion, the negative binomial distribution provided superior model fit. 40 Given limited power, negative binomial regression and P-values are reported for exploratory purposes only.…”

“…Details of trial design, participants and procedures have been reported previously. 33,34 The trial was registered with ClinicalTrials.gov (trial identifier: NCT04424745).…”

“…Details of trial design, participants and procedures have been reported previously. 33,34 The trial was registered with ClinicalTrials.gov (trial identifier: NCT04424745). All procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.…”

Neuromodulation of Eating Disorders: A Review of Underlying Neural Network Activity and Neuromodulatory Treatments

“… Greater reduction in binge eating frequency in the tDCS + FRIC group vs. sham + FRIC group. BED Flynn, 2023 [ 74 ] UK 80 2 mA 10 sessions over 2–3 weeks Bilateral dlPFC Currently underway BDI, Beck Depression Inventory; EDI, Eating Disorders Inventory; FRIC; Food-related inhibitory control training; MEDCQ-R, Mizes Eating Disorder Cognition Questionnaire-Revised; UPPS, UPPS Impulsive Behavior Scale. …”

“…Full results from the work by the group are pending. The TANDEM trial by Flynn and colleagues is another exciting single-blind, sham-controlled randomized trial that will look at self-administered at-home anodal tDCS to the right dlPFC with concurrent ABM training [ 74 ].…”