Abstract Background Fatigue is an unresolved issue affecting quality of life in patients with inflammatory bowel disease (IBD). Although few intervention studies have targeted fatigue, psychological approaches have shown promise for fatigue management. However, face-to-face programs are difficult to implement in clinical practice due to limited manpower. This study aims to evaluate the effectiveness of a mental care app for fatigue management among patients with IBD in remission, and explore factors related to its acceptability and effectiveness. Here, we describe the study protocol and preliminary results of this randomised controlled trial (RCT). Methods This is an open-label, waiting-list controlled RCT. Eligible participants are adults (≥18 years) diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) who meet the following criteria: clinical remission (CDAI 150 or partial Mayo score ≤1) and at least mild fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue FACIT-F 40). Participants will be required to understand Japanese and provide written informed consent. Exclusion criteria include lack of access to a smartphone app, ongoing psychiatric treatment, participation in other trials, no planned clinic visit within 2–5 months post-intervention, or investigator-assessed ineligibility. The participants will be randomised to either an intervention or waiting-list control group (1:1) using stratified block randomisation based on three factors: (1) disease type (CD or UC); (2) sex (female or male); and (3) baseline FACIT-F ( 30 or ≥ 30). Intervention will comprise a 7-week cognitive-behavioral therapy (CBT)-based educational program with supportive messages addressing factors associated with fatigue and self-management in IBD. Primary outcome is fatigue measured by the FACIT-F scale. Secondary outcome is self-efficacy for IBD self-management measured by the 13-item Inflammatory Bowel Disease Self-Efficacy Scale. Based on an assumed effect size of 0.3, 80% power, and 5% significance level (two-tailed test), sample size will be 175 per group. Results Recruitment began on July 28, 2025. By October 29, 387 patients with IBD in clinical remission had been invited to participate in the study. Among them, 272 met the eligibility criteria and were randomised, while 115 (30%) had FACIT-F ≥41 and were excluded. The participants are currently participating in an ongoing trial using a mental care app designed to support the self-management of fatigue. Conclusion This study will evaluate whether an app-based CBT program can reduce fatigue and enhance self-efficacy for self-management in patients with IBD in remission. These findings are expected to contribute to the development of a scalable technology-based psychological support for IBD care. Reference: Trial registration: UMIN000057278 Conflict of interest: Tanaka, Makoto: Lecture fee: Takeda Pharmaceutical Co. Ltd. (2024) Research support: Awarefy lnc. (2025) Sakagami, Kayoko: No conflicts Wakai, Sayaka: No conflicts Kawakami, Aki: There is no conflict of interest. Takashina, Hikari: Employee of Awarefy Inc. Kang, Jeongae: I am employed by Awarefy Inc. Nagahori, Masakazu: I have received lecture fees and others from for the past three years from the companies below. Pfizer Inc. Takeda Pharmaceutical Company Limited Mochida Pharmaceutical Co., Ltd. AbbVie GK Mitsubishi Tanabe Pharma Corporation Zeria Pharmaceutical Co., Ltd. Janssen Pharmaceutical K.K. Kyorin Pharmaceutical Co., Ltd. Gilead Sciences, Inc. Ito, Hiroaki: Lecture Fees: AbbVie, Mochida Pharmaceutical, Pfizer, and Bristol-Myers.
Tanaka et al. (Thu,) studied this question.