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Published on: August 1, 2019
Evaluation of a Mental Health Care App-Based Fatigue Management Program for Patients With Inflammatory Bowel Disease
Makoto Tanaka1, Sayaka Wakai1, Kayoko Sakagami2
1Department of Adult Health Nursing, Graduate School of Health Care Sciences, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 1138519, Japan, 81 358035351.
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 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.
Methods:
This was an open-label, waitlist-controlled randomized controlled trial. Eligible participants were adults (≥18 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-based educational course, supplemented by adjunctive support messages. The primary outcome was fatigue, measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (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.
Results:
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.
Conclusions:
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.
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