Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 2, 2026
Date Accepted: Aug 11, 2026
Evaluation of a mental health care app-based fatigue management program for patients with inflammatory bowel disease in remission: A randomized controlled trial protocol
ABSTRACT
Background:
Fatigue remains a major unresolved issue affecting the quality of life of patients with inflammatory bowel disease (IBD), even during clinical remission. Scalable psychological approaches are needed to support effective fatigue management.
Objective:
The aim of this study is to evaluate the effectiveness of a mental health care app for fatigue management among patients with IBD in remission and to explore factors related to its acceptability and effectiveness.
Methods:
This is an open-label, waitlist randomized controlled trial. Eligible participants are adults (≥18 years) diagnosed with Crohn’s disease or ulcerative colitis who meet remission criteria and have at least mild fatigue. Participants will be randomized 1:1 using stratified block randomization based on disease type, sex, and baseline fatigue severity. The intervention consists of a seven-week cognitive-behavioral therapy-based educational program with supportive messages. The primary outcome is fatigue, measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and the secondary outcome is self‑efficacy, measured using the Inflammatory Bowel Disease Self‑Efficacy Scale Short Form (IBD-SES13). A sample size of 175 participants per group is required.
Results:
Recruitment of participants began on July 28, 2025, and closed on February 24, 2026. A total of 502 patients with IBD in clinical remission were invited to participate in the study. Among them, 351 met the eligibility criteria and were randomized, while 151 (30%) had FACIT-F scores of 41 or higher and were excluded. Follow-up is ongoing.
Conclusions:
This study may contribute valuable knowledge regarding the feasibility, acceptability, and potential impact of app‑based psychoeducation on fatigue in patients with IBD. The findings will support future refinement of the intervention and inform large-scale evaluations and implementation efforts. Clinical Trial: The University Hospital Medical Information Network UMIN000057278 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000065453
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