ArticleBMC gastroenterology2026
Remote Self-help cognitive-behavioural Therapy for irritable bowel syndrome (ReSeT): protocol for a randomised controlled trial.
Article in BMC gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundIrritable bowel syndrome (IBS) may significantly impair the quality of life (QoL) of affected individuals and carries substantial socio-economic consequences. Cognitive-behavioural therapy (CBT) is recommended as one treatment option for IBS. However, its widespread use is limited by a shortage of qualified therapists, insufficient facilities, and the burden of hospital visits. Internet-based CBT (iCBT) has the potential to overcome these challenges. We aim to evaluate the efficacy and cost-effectiveness of iCBT for treating drug-refractory IBS through rigorous methodology.
methodThis is a single-blind, multicentre, randomised controlled trial. We will recruit adults (≥ 18 years) with moderate-to-severe drug-refractory IBS (target sample size: 132, allowing for an estimated 20% attrition) and randomise them 1:1, stratified by baseline IBS severity. The intervention arm will receive iCBT with interoceptive exposure (iCBT-IE), including brief therapist videoconferences, while the control arm will receive IBS disease education and lifestyle advice. Both arms will undertake 10-week internet-based programmes in addition to continuing treatment as usual. The primary outcomes will be changes in IBS severity (IBS-SSS) and IBS-specific QoL (IBS-QOL) from baseline to week 13, with long-term effects assessed up to week 52. IBS-SSS (range: 0–500) decreases with improvement, whereas IBS-QOL (range: 0–100) increases with improvement. Analyses will follow the intention-to-treat principle, using a mixed-effects model for repeated measures (MMRM). Cost-effectiveness will be assessed from the payer’s perspective using IBS-SSS, quality-adjusted life years (QALYs), and healthcare resource use. Productivity will be evaluated from a societal perspective using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). DISCUSSION: Telepsychotherapy, including iCBT, is expected to expand because of its convenience. However, the efficacy and cost-effectiveness of non-verbal therapists interventions in telepsychotherapy have not been adequately evaluated. Evaluating iCBT with videoconferencing guidance is therefore crucial to broaden treatment options for IBS.
trial registrationRegistered on 1 November 2023 in the UMIN-CTR ( https://www.umin.ac.jp/ctr/index-j.htm ), ID: UMIN000052457. This is the first version of the protocol.
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