Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial

Sayo Hamatani; Kazuki Matsumoto; Gerhard Andersson; Yukiko Tomioka; Shusuke Numata; Rio Kamashita; Atsushi Sekiguchi; Yasuhiro Sato; Shin Fukudo; Natsuki Sasaki; Masayuki Nakamura; Ryoko Otani; Ryoichi Sakuta; Yoshiyuki Hirano; Hirotaka Kosaka; Yoshifumi Mizuno

doi:10.2196/49828

Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial

JMIR Res Protoc. 2023 Sep 19:12:e49828. doi: 10.2196/49828.

Authors

Sayo Hamatani^#^{1

2

3}, Kazuki Matsumoto⁴, Gerhard Andersson^{5

6

7}, Yukiko Tomioka⁸, Shusuke Numata⁸, Rio Kamashita⁹, Atsushi Sekiguchi¹⁰, Yasuhiro Sato¹¹, Shin Fukudo¹¹, Natsuki Sasaki¹², Masayuki Nakamura¹², Ryoko Otani¹³, Ryoichi Sakuta¹³, Yoshiyuki Hirano⁹, Hirotaka Kosaka^{1

2

3

14}, Yoshifumi Mizuno^{1

2

3}

Affiliations

¹ Research Center for Child Mental Development, University of Fukui, Fukui, Japan.
² Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, Japan.
³ Department of Child and Adolescent Psychological Medicine, University of Fukui Hospital, Fukui, Japan.
⁴ Division of Clinical Psychology, Kagoshima University Hospital, Kagishima, Japan.
⁵ Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.
⁶ Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.
⁷ Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
⁸ Department of Psychiatry, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.
⁹ Research Center for Child Mental Development, Chiba University, Chiba, Japan.
¹⁰ Department of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.
¹¹ Department of Psychosomatic Medicine, Tohoku University Hospital, Sendai, Japan.
¹² Department of Psychiatry, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
¹³ Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
¹⁴ Department of Neuropsychiatry, University of Fukui, Fukui, Japan.

^# Contributed equally.

PMID: 37725414
PMCID: PMC10548332
DOI: 10.2196/49828

Abstract

Background: Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.

Objective: This paper presents a research protocol for strategies to examine the effects of guided ICBT.

Methods: This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.

Results: This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.

Conclusions: This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.

Trial registration: University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522.

International registered report identifier (irrid): DERR1-10.2196/49828.

Keywords: CBT; ICBT; RCT; binge eating; bulimia; bulimia nervosa; cognitive behavioral therapy; controlled trial; eating; internet-based cognitive behavioral therapy; mobile phone; protocol; purging; randomized; randomized controlled trial.

©Sayo Hamatani, Kazuki Matsumoto, Gerhard Andersson, Yukiko Tomioka, Shusuke Numata, Rio Kamashita, Atsushi Sekiguchi, Yasuhiro Sato, Shin Fukudo, Natsuki Sasaki, Masayuki Nakamura, Ryoko Otani, Ryoichi Sakuta, Yoshiyuki Hirano, Hirotaka Kosaka, Yoshifumi Mizuno. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.09.2023.