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

Hitomi Kawanishi,Yasushi Fujii,Kenta Toda,Tetsuya Ando,Masayasu Shoji,Norio Sugawara,Tadahiro Yamazaki,Atsushi Sekiguchi,Tomotaka Shoji,Yoshitoshi Tomita,Keisuke Kawai,Shin Fukudo,Kenji Hatano,Chisato Ohara,Hiroe Kikuchi,Kazuhiro Yoshiuchi,Misako Funaba,Masafumi Murakami,Kazushi Maruo

doi:10.1186/s13030-019-0155-2

Abstract

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.Trial registrationThe trial was registered to the University Hospital Medical Information Network Clinical Trial Registry: UMIN, No. UMIN000030620 (Date of registration: December 28, 2017).

Highlights

Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder that affects about 14% [1] of the Japanese population
Specific psychotherapies including cognitive behavioral therapy (CBT) are recommended in the clinical guideline issued by the Japanese Society of Gastroenterology as the third step of irritable bowel syndrome (IBS) treatment that has been refractory to the first step and second step treatments [14]
Previous studies have indicated that the standard medications (TAU), such as bulking agents and antispasmodics, have low responsiveness [40,41,42] and that many patients with IBS suffer from ongoing symptoms

Summary

Introduction

Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder that affects about 14% [1] of the Japanese population. Evidence for IBS treatment efficacy using cognitive behavioral therapy (CBT) has been growing [8,9,10]. Specific psychotherapies including CBT are recommended in the clinical guideline issued by the Japanese Society of Gastroenterology as the third step of IBS treatment that has been refractory to the first step (lifestyle advise and gut-targeted pharmacotherapies) and second step (psychopharmacological agents and brief psychotherapies) treatments [14]. There 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. 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)

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