Evidence map›Paper›PMID 42803779›Full record

Trial reportJMIR research protocols2026

Evaluation of a Mental Health Care App-Based Fatigue Management Program for Patients With Inflammatory Bowel Disease in Remission: Protocol for a Randomized Controlled Trial.

Makoto Tanaka, Sayaka Wakai, Kayoko Sakagami, Aki Kawakami, Hikari N Takashina, Jeongae Kang, Masakazu Nagahori, Hiroaki Ito

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Makoto TanakaDepartment 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.ORCID http://orcid.org/0000-0002-1826-3111
Sayaka WakaiDepartment 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.ORCID http://orcid.org/0009-0006-2689-7399
Kayoko SakagamiKinshukai Infusion Clinic, Osaka, Japan.ORCID http://orcid.org/0009-0002-8485-3336
Aki KawakamiDepartment 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.ORCID http://orcid.org/0000-0003-0903-9537
Hikari N TakashinaAwarefy Mental Research Institute, Awarefy Inc., Tokyo, Japan.ORCID http://orcid.org/0000-0003-3094-0573
Jeongae KangAwarefy Mental Research Institute, Awarefy Inc., Tokyo, Japan.ORCID http://orcid.org/0009-0004-2922-8890
Masakazu NagahoriHealth Science Research & Development Center, Institute of Science Tokyo Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0002-5323-7058
Hiroaki ItoKinshukai Infusion Clinic, Osaka, Japan.ORCID http://orcid.org/0000-0001-8503-141X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

Cognitive Behavioral TherapyFatigueInflammatory Bowel DiseasesMobile ApplicationsAdultFemaleHumansMaleMiddle AgedQuality of LifeRemission Inductioncognitive behavioral therapyfatigueinflammatory bowel diseaseinternet-based interventionpsychological supportself‑care

Identifiers

PMID42803779
PMCPMC13618207

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.