Web-Based Guided Self-Help vs Treatment as Usual for Binge-Eating Disorder: A Randomized Clinical Trial.

Importance: Preliminary findings suggest that web-based guided self-help, which is easily scalable and shorter in duration, may be an effective treatment for binge-eating disorder, yet it is rarely offered or only used as a first-line treatment in a stepped-care approach. Despite its benefits and cost savings, few studies have directly compared it with treatment as usual. Evaluating a psychological treatment that requires minimal therapist involvement is crucial for reducing costs, improving accessibility, and promoting patient agency in recovery. Objective: To assess whether web-based guided self-help is noninferior to treatment as usual for binge-eating disorder. Design, Setting, and Participants: This 2-arm noninferiority randomized clinical trial of adults with binge-eating disorder was conducted between November 2021 and October 2024 at a specialized center for eating disorders in the Netherlands. Interventions: Participants received either 12 weeks of web-based guided self-help or 20 weeks of comprehensive treatment as usual. Main Outcome and Measures: The primary outcome was the comparative difference in the number of objective binge-eating episodes at the end of treatment and at 20 weeks after treatment. Secondary measures included full remission, dropout, therapeutic alliance, body dissatisfaction, clinical impairment, and body mass index. To examine differences in outcomes between groups, linear mixed model analyses with restricted maximum likelihood estimation, multilevel negative binomial regression, and multilevel binary logistic regression were used. Results: Among a referred sample of 207 adults with binge-eating disorder, 187 participants (160 females [85.6%]; mean [SD] age, 38.1 [0.9] years) were randomized to web-based guided self-help (n = 93) or treatment as usual (n = 94). With a margin of 1 additional binge-eating episode, a contrast estimate noninferiority was found between groups at the end of treatment (-0.82 [95% CI, -1.86 to 0.21]; P = .12) and at 20 weeks after treatment (-0.58 [95% CI, -1.41 to 0.26]; P = .17). At both assessments, a difference in objective binge-eating episodes was found in favor of web-based guided self-help (end of treatment: 3.24 [95% CI, 2.42-4.33] vs 4.06 [3.17-5.20]; 20 weeks after treatment: 1.27 [95% CI, 0.81-1.97] vs 1.84 [95% CI, 1.24-2.73]). Conclusions and Relevance: In this randomized clinical trial, web-based guided self-help was noninferior to treatment as usual in reducing binge eating, despite its shorter duration and lower level of therapist involvement. These results suggest more evidence for the effectiveness of web-based mental health care, which is an important finding amid global challenges with mental health staff shortages, long waiting lists, and high treatment costs. Trial Registration: Central Committee on Research Involving Human Subjects Identifier: NL76368.100.21.