Background: To investigate non-patient irritable bowel syndrome (IBS) change to IBS and to determine factors predictive of the onset of IBS, individual biological factors, psychological factors, behavioral factors, and environmental factors were examined.

Background 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. 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). Methods This 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. Discussion To 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 registration The trial was registered to the University Hospital Medical Information Network Clinical Trial Registry: UMIN, No. UMIN000030620 (Date of registration: December 28, 2017).

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder, which severely impairs the quality of life of patients. Treatment of refractory IBS patients is needed, but it is not yet widely available. Therefore, we previously developed a Japanese version of cognitive behavioral therapy with interoceptive exposure (CBT-IE) involving 10 face-to-face sessions to treat refractory IBS patients. To disseminate this treatment of IBS in places where therapists are limited, we further developed a hybrid CBT-IE program with complementary video materials that include psychoeducation and homework instructions so that patients can prepare for face-to-face sessions in advance at home and the session time can be shortened, thereby reducing the burden on both patient and therapist. In this study, we conducted a trial to evaluate the feasibility, efficacy, and safety of the hybrid CBT-IE program for Japanese IBS patients. The study was a single-arm, open-label pilot clinical trial. A total of 16 IBS patients were included in the study and 14 patients completed the intervention, which consisted of 10 weekly individual hybrid CBT-IE sessions. We performed an intention to treat analysis. The primary outcome measure for the efficacy of the intervention was a decrease in the severity of IBS symptoms. The feasibility and safety of the intervention were examined by the dropout rate and recording of adverse events, respectively. The dropout rate of the hybrid CBT-IE was comparable to that of our previous CBT-IE with only face-to-face sessions and no adverse events were recorded. The severity of IBS symptoms within-group was significantly decreased from the baseline to mid-treatment [Hedges' g = −0.98 (−1.54, −0.41)], post-treatment [Hedges' g = −1.48 (−2.09, −0.88)], 3-month follow-up [Hedges' g = −1.78 (−2.41, −1.14)], and 6-month follow-up [Hedges' g = −1.76 (−2.39, −1.13)]. Our results suggest that the hybrid CBT-IE is effective and could be conducted safely. To confirm the effectiveness of the hybrid CBT-IE, it is necessary to conduct a multicenter, parallel-design randomized control trial.Clinical Trial Registration: [https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041376], identifier [UMIN000036327].