{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T15:55:26Z","timestamp":1790610926698,"version":"4.1.0"},"reference-count":31,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n The aim of this study is to evaluate the effectiveness of a multicomponent mobile cognitive behavioral intervention package for fatigue management among patients with IBD in remission and to explore factors associated with engagement with the intervention and its effectiveness.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This was an open-label, waitlist-controlled randomized controlled trial. Eligible participants were adults (\u226518 years) diagnosed with Crohn disease or ulcerative colitis who met remission criteria and had at least mild fatigue. Participants were randomized 1:1 using stratified block randomization based on disease type, sex, and baseline fatigue severity. The intervention was a multicomponent mobile intervention package centered on a 7-week cognitive behavioral therapy\u2013based educational course, supplemented by adjunctive support messages. The primary outcome was fatigue, measured using the Functional Assessment of Chronic Illness Therapy\u2014Fatigue (FACIT-F), and the secondary outcome was self-efficacy, measured using the 13-item Inflammatory Bowel Disease Self-Efficacy Scale Short Form (IBD-SES13). A sample size of 175 participants per group was required.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Recruitment of participants began on July 28, 2025, and ended on February 24, 2026. A total of 502 patients with IBD in clinical remission agreed to participate and were assessed for eligibility. Among them, 351 met the eligibility criteria and were randomized, while 151 (30.0%) had FACIT-F scores of 40 or higher and were excluded. Currently, follow-up is ongoing. The clinical outcome data will be analyzed after follow-up is completed, and the results are expected to be submitted for publication in 2027.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This study may contribute valuable knowledge regarding participant engagement and the potential impact of a multicomponent mobile cognitive behavioral intervention package on fatigue in patients with IBD. The findings will support future refinement of the intervention and inform large-scale evaluations and implementation efforts.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/96593","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T15:01:20Z","timestamp":1790607680000},"page":"e96593-e96593","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of a Mental Health Care App\u2013Based Fatigue Management Program for Patients With Inflammatory Bowel Disease in Remission: Protocol for a Randomized Controlled 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