Hamatani Sayo, Matsumoto Kazuki, Andersson Gerhard, Tomioka Yukiko, Numata Shusuke, Kamashita Rio, Sekiguchi Atsushi, Sato Yasuhiro, Fukudo Shin, Sasaki Natsuki, Nakamura Masayuki, Otani Ryoko, Sakuta Ryoichi, Hirano Yoshiyuki, Kosaka Hirotaka, Mizuno Yoshifumi
Research Center for Child Mental Development, University of Fukui, Fukui, Japan.
Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, Japan.
JMIR Res Protoc. 2023 Sep 19;12:e49828. doi: 10.2196/49828.
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.
This paper presents a research protocol for strategies to examine the effects of guided ICBT.
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.
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.
This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.
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.
众所周知，个体面对面认知行为疗法对神经性贪食症（BN）有效。由于患者生活的地区和文化中的食物差异很大，因此在针对BN的认知行为疗法中，治疗方案的文化适应性尤为重要。最近，针对患有BN的日本女性开发了一种基于互联网的认知行为疗法（ICBT）方案，并使其适应日本饮食文化。然而，以前没有随机对照试验研究过ICBT的有效性。
本文介绍了一项研究方案，用于探讨指导性ICBT效果的策略。
本研究设计为一项多中心、前瞻性、评估者盲法随机对照试验。治疗组将分为仅接受常规治疗（TAU）作为对照组，以及ICBT联合TAU作为干预组。主要结局是由独立评估者在治疗前后评估的暴饮暴食和清除行为的总数。次要结局将包括饮食失调严重程度、抑郁、焦虑、生活质量、治疗满意度和工作联盟的测量指标。治疗满意度和工作联盟仅在评估后进行测量。其他指标将在基线、干预后和随访时进行评估，结局将基于意向性分析进行分析。
本研究将于2022年8月至2026年10月在日本7家不同的医疗机构进行。参与者招募于2022年8月19日开始，计划持续到2024年7月。首批参与者于2022年9月8日登记。
这是日本第一项比较ICBT和TAU对BN患者有效性的多中心随机对照试验。
大学医院医学信息网络UMIN000048732；https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522。
国际注册报告识别码（IRRID）：DERR1-10.2196/49828。
