Work

Internet-delivered cognitive behavioral therapy and FODMAP diet for adults with irritable bowel syndrome: A four-arm randomized controlled trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disorder associated with reduced quality of life and psychological distress. Although several effective self-management interventions exist, patient access is often limited. Internet-delivered interventions may enhance accessibility and scalability. We aimed to evaluate the effectiveness of a CBT-based module, a FODMAP diet module, or their combination, when added to internet-delivered general patient education, compared to general patient education alone, on IBS symptom severity in adults. In this four-arm randomized controlled trial, 642 adults with IBS were allocated to ( Ford et al., 2020 ( Ford et al., 2020 )) internet-delivered general patient education alone (control) or with the addition of ( Oka et al., 2020 ( Oka et al., 2020 )) a CBT-based module, Camilleri (2021) ( Camilleri, 2021 ) a FODMAP diet module, or ( Mearin et al., 2016 ( Mearin et al., 2016 )) both the CBT-based module and the FODMAP diet module. All groups could receive personalized guidance from a clinical dietitian via the platform's asynchronous messaging function. The primary outcome was the proportion of IBS symptom responders at 3 months, defined as a ≥ 50-point reduction on the IBS severity scoring system. Secondary outcomes included IBS-related quality of life, psychological symptoms, module adherence, and treatment satisfaction. Of 557 participants who received their allocated intervention, 373 (67%) completed questionnaires at the primary endpoint at 3 months. Responder rates were comparable across all groups at 3 months ranging from 42.6% to 45.1%, with no significant between-group differences in the primary outcome (OR (95% CI) = 0.97 (0.54 to 1.72), p = 0.989). Adherence to the content-specific modules was low, with 9–20% of participants completing the CBT-based and/or FODMAP diet module. All groups showed within-group improvements in IBS symptoms and IBS-related quality of life in secondary continuous analyses, but these did not translate into between-group effects. All intervention groups, including internet-delivered general patient education alone and general patient education with an additional CBT-based and/or FODMAP diet module, demonstrated clinically and statistically meaningful improvements in IBS symptoms and IBS-related quality of life. Although no additional benefit of the content-specific modules was observed, this finding should be interpreted in the context of the low adherence to these modules. These findings highlight the value of low-intensity internet-delivered interventions for IBS within resource-constrained health systems and emphasize the importance of addressing adherence and engagement in future research. ClinicalTrials.gov ID: NCT06117865 . Registered 31.10.2023. • This novel randomized controlled trial examines the effectiveness of a CBT-based module, a FODMAP diet module, or their combination, when added to internet-delivered general patient education, compared to general patient education alone, on IBS symptom severity in adults. • The findings highlight the potential of low-intensity internet-delivered interventions to produce clinically meaningful improvements in IBS symptoms, suggesting that this may be an effective option for many individuals with IBS. • Low adherence limited the ability to evaluate the added value of the content-specific modules, underscoring the need to examine factors that influence treatment expectations, adherence, and engagement in internet-delivered IBS interventions.

Source: Internet Interventions

DOI: 10.1016/j.invent.2026.100949