Abstract
ABSTRACT
Objective
To evaluate the feasibility of a randomized pilot trial of group‐based cognitive behavioral therapy (CBT) for binge eating disorder (BED) in individuals with type 2 diabetes, and to estimate exploratory clinical outcomes to inform the design of a future efficacy trial.
Method
Thirty‐four participants with type 2 diabetes and BED were randomized 1:1 to group CBT or waitlist. Feasibility outcomes included recruitment, randomization, intervention adherence, and follow‐up completion. Exploratory clinical outcomes were analyzed using an intention‐to‐treat mixed model, with weekly binge‐eating episodes evaluated as the primary clinical outcome for a future efficacy trial. Other exploratory clinical outcomes included other BED symptoms and glycated hemoglobin (HbA1c).
Results
Recruitment was resource‐intensive, with 2646 individuals screened to randomize 34 participants. Randomization was completed as planned, but treatment initiation and follow‐up completion were lower in the group CBT arm. Postintervention data on weekly binge‐eating episodes were available for 11/17 participants in the CBT group and 16/17 in the waitlist group. This differential follow‐up may have introduced attrition bias. The exploratory between‐group estimate for binge‐eating episodes favored group CBT, with an adjusted difference in change of −2 episodes per week (95% CI: −4.81 to 0.68), corresponding to Cohen's
d
= −0.62 (95% CI: −1.45 to 0.21). Exploratory clinical outcome estimates were intended to inform future trial design rather than to test efficacy.
Discussion
Group CBT delivery appeared acceptable among participants who initiated treatment, but recruitment and follow‐up require refinement before proceeding to a future efficacy trial.