Web-based guided self-help cognitive behavioral therapy-enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol

Ella van Beers; Bernou Melisse; Margo de Jonge; Jaap Peen; Elske van den Berg; Edwin de Beurs

doi:10.3389/fpsyt.2024.1332360

Web-based guided self-help cognitive behavioral therapy-enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol

Front Psychiatry. 2024 Feb 16:15:1332360. doi: 10.3389/fpsyt.2024.1332360. eCollection 2024.

Authors

Ella van Beers¹, Bernou Melisse^{1

2}, Margo de Jonge¹, Jaap Peen³, Elske van den Berg^{1

3}, Edwin de Beurs^{3

4}

Affiliations

¹ Novarum Center for Eating Disorders & Obesity, Amstelveen, Netherlands.
² Utrecht University, Department of Clinical Psychology, Utrecht, Netherlands.
³ Department of Research, Arkin Mental Health Institute, Amsterdam, Netherlands.
⁴ Leiden University, Department of Clinical Psychology, Leiden, Netherlands.

Abstract

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.

Keywords: binge eating disorder; cognitive behavioral therapy-enhanced; guided self-help; randomized controlled trial; web-based treatment.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. Funding for this study has been provided by an anonymous family foundation. The funding provided by the anonymous private family foundation has no conflict of interest in this research. The foundation was not involved in the design, implementation, or presentation of this work, nor are they involved with any of the author affiliations, the institution the proposed study will be conducted at, or with the Dutch Application that is being created based on the treatment being tested.