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Hamatani S, Matsumoto K, Andersson G, Tomioka Y, Numata S, Kamashita R, Sekiguchi A, Sato Y, Fukudo S, Sasaki N, Nakamura M, Otani R, Sakuta R, Hirano Y, Kosaka H, Mizuno Y
Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial
Guided Internet-Based Cognitive Behavioural Therapy for Women with Bulimia Nervosa: Protocol for Multicentre Randomised Controlled Trial in Japan
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
ABSTRACT
Background:
Individual face-to-face cognitive behavioural therapy (CBT) 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 CBT for BN. Recently, an internet-based CBT (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomised 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 multicentre, prospective, randomised, assessor-blinded clinical 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 behaviours, assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life (QOL), treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured at post-assessment only. Other measures will be assessed at baseline, post-intervention, and follow-up, and the outcomes will be analysed on an intention-to-treat basis.
Results:
This study will be conducted at seven 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 multicentre randomised controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN. Clinical Trial: UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522
Citation
Please cite as:
Hamatani S, Matsumoto K, Andersson G, Tomioka Y, Numata S, Kamashita R, Sekiguchi A, Sato Y, Fukudo S, Sasaki N, Nakamura M, Otani R, Sakuta R, Hirano Y, Kosaka H, Mizuno Y
Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial