Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan

BackgroundThere is growing evidence of the treatment efficacy of cognitive behavioral therapy (CBT) for irritable bowel syndrome (IBS). CBT is recommended by several practice guidelines for patients with IBS if lifestyle advice or pharmacotherapy has been ineffective. Manual-based CBT using interoceptive exposure (IE), which focuses on the anxiety response to abdominal symptoms, has been reported to be more effective than other types of CBT. One flaw of CBT use in general practice is that it is time and effort consuming for therapists. Therefore, we developed a set of complementary video materials that include psycho-education and homework instructions for CBT patients, reducing time spent in face-to-face sessions while maintaining treatment effects. The purpose of this study is to examine the effects of CBT-IE with complementary video materials (CBT-IE-w/vid) in a multicenter randomized controlled trial (RCT).MethodsThis study will be a multicenter, parallel-design RCT. Participants diagnosed with IBS according to the Rome IV diagnostic criteria will be randomized to either the treatment as usual (TAU) group or the CBT-IE-w/vid + TAU group. CBT-IE-w/vid consists of 10 sessions (approximately 30 min face-to-face therapy + viewing a video prior to each session). Patients in the CBT-IE-w/vid group will be instructed to pre- view 3- to 13-min videos at home prior to each face-to-face therapy visit at a hospital. The primary outcome is the severity of IBS symptoms. All participants will be assessed at baseline, mid-treatment, post-treatment, and follow-up (3 months after post assessment). The sample will include 60 participants in each group.DiscussionTo our knowledge, this study will be the first RCT of manual-based CBT for IBS in Japan. By using psycho-educational video materials, the time and cost of therapy will be reduced. Manual based CBTs for IBS have not been widely adopted in Japan to date. If our CBT-IE-w/vid program is confirmed to be more effective than TAU, it will facilitate dissemination of cost-effective manual-based CBT in clinical settings

Validity and reliability of the Japanese versions of cognitive and behavioral scales for irritable bowel syndrome

Abstract Background The Cognitive Scale for Functional Bowel Disorders (CS-FBD) and Irritable Bowel Syndrome-Behavioral Responses Questionnaire (IBS-BRQ) are a useful measures to assess cognitive-behavioral aspects in individuals with IBS. This study aimed to confirm the reliability and validity of the Japanese versions of the CS-FBD (CS-FBD-J) and IBS-BRQ (IBS-BRQ-J). Methods Participants comprised 192 students and 22 outpatients diagnosed with irritable bowel syndrome (IBS). There were 76 students who met the diagnostic criteria for IBS and two students who received treatment for IBS. Participants completed questionnaires containing the CS-FBD-J, IBS Severity Index (IBS-SI), Visceral Sensitivity Index (VSI), 24-item Dysfunctional Attitudes Scale (DAS-24), Hospital Anxiety and Depression Scale (HADS), and Social Adaptation Self-evaluation Scale (SASS). Results Our exploratory factor analysis revealed that the CS-FBD-J had a unidimensional factor structure and that the factor loadings for two of the 25 items were less than 0.4. The IBS-BRQ-J had a two-factor structure, and the factor loadings for eight of the 26 items were less than 0.4. The confirmatory factor analysis for the 18-item version of IBS-BRQ-J showed that the model fit indices were not sufficient. The CS-FBD-J and IBS-BRQ-J had significant, moderate correlations with the IBS-SI and VSI in the IBS and control groups. Correlation between the DAS-24 and the CS-FBD-J was not significant. The CS-FBD-J and IBS-BRQ-J were significantly correlated to the HADS and SASS (IBS-BRQ-J) only in the IBS group. The scores of CS-FBD-J and IBS-BRQ-J showed significant group differences between the IBS patient group, non-patient IBS group, and control group. The internal consistencies of the CS-FBD-J and IBS-BRQ-J were high. The item-total correlation analysis for the CS-FBD-J and IBS-BRQ-J showed that the correlations between each item and the total score were significant. Conclusion This study confirmed the reliability and validity of the 23-item version of the CS-FBS-J and the 18-item version of the IBS-BRQ-J with the deletion of items with low factor loadings. Regarding the IBS-BRQ-J, two factor structures were confirmed (factor 1: behavior obsessed with abdominal symptoms, factor 2: avoidance of abdominal symptoms and associated difficulties) although the model fit of the structure needs further study