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

Abstract

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).

Hybrid Cognitive Behavioral Therapy With Interoceptive Exposure for Irritable Bowel Syndrome: A Feasibility Study

“…To confirm the effectiveness of the hybrid CBT-IE, we are conducting a multicenter, parallel-design randomized control trial ( 23 ). We need to increase the number of participants and investigate the mechanisms of the hybrid CBT-IE, focusing on attentional function, changes in dysfunctional thinking (e.g., catastrophic thoughts), and reducing the use of safety behavior and safety signals included the hybrid CBT-IE.…”

Treating irritable bowel syndrome through an interdisciplinary approach

“…Antidepressants can not only be helpful in reducing abdominal and global IBS symptoms, but may also change the perception of pain and favorably affect comorbid psychoemotional symptoms [4,13,34]. Nevertheless, the efficacy of TCAs and SSRIs often does not surpass that of other drugs [35].…”

“…However, a systematic review has revealed no sufficient evidence for the effectiveness of online CBT in GI disorders, including IBS [75]. In order to reduce the expenses of psychotherapeutic interventions, programs of selfadministered management are also being introduced [35,76-78]. They usually refer to minimal contact CBT and include selfstudy materials.…”

Conventional and Alternative Measures for IBS Management

“…Gut-focused hypnotherapy was found to be effective in primary and secondary care [28], but only small changes were found in intestinal microbiota composition [29]. CBT-IE for IBS includes exposure to abdominal sensations in addition to psychoeducation, self-monitoring, cognitive restructuring, attention training, and in vivo exposure, which are often used in traditional CBT [30]. Home-based version of CBT produced significant and sustained gastrointestinal symptom improvement for patients with IBS compared with education [31].…”