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Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan
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 intero...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6551860/ https://www.ncbi.nlm.nih.gov/pubmed/31178921 http://dx.doi.org/10.1186/s13030-019-0155-2 |
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author | Kawanishi, Hitomi Sekiguchi, Atsushi Funaba, Misako Fujii, Yasushi Yoshiuchi, Kazuhiro Kikuchi, Hiroe Kawai, Keisuke Maruo, Kazushi Sugawara, Norio Hatano, Kenji Shoji, Tomotaka Yamazaki, Tadahiro Toda, Kenta Murakami, Masafumi Shoji, Masayasu Ohara, Chisato Tomita, Yoshitoshi Fukudo, Shin Ando, Tetsuya |
author_facet | Kawanishi, Hitomi Sekiguchi, Atsushi Funaba, Misako Fujii, Yasushi Yoshiuchi, Kazuhiro Kikuchi, Hiroe Kawai, Keisuke Maruo, Kazushi Sugawara, Norio Hatano, Kenji Shoji, Tomotaka Yamazaki, Tadahiro Toda, Kenta Murakami, Masafumi Shoji, Masayasu Ohara, Chisato Tomita, Yoshitoshi Fukudo, Shin Ando, Tetsuya |
author_sort | Kawanishi, Hitomi |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-6551860 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65518602019-06-07 Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan Kawanishi, Hitomi Sekiguchi, Atsushi Funaba, Misako Fujii, Yasushi Yoshiuchi, Kazuhiro Kikuchi, Hiroe Kawai, Keisuke Maruo, Kazushi Sugawara, Norio Hatano, Kenji Shoji, Tomotaka Yamazaki, Tadahiro Toda, Kenta Murakami, Masafumi Shoji, Masayasu Ohara, Chisato Tomita, Yoshitoshi Fukudo, Shin Ando, Tetsuya Biopsychosoc Med Research 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). BioMed Central 2019-06-06 /pmc/articles/PMC6551860/ /pubmed/31178921 http://dx.doi.org/10.1186/s13030-019-0155-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Kawanishi, Hitomi Sekiguchi, Atsushi Funaba, Misako Fujii, Yasushi Yoshiuchi, Kazuhiro Kikuchi, Hiroe Kawai, Keisuke Maruo, Kazushi Sugawara, Norio Hatano, Kenji Shoji, Tomotaka Yamazaki, Tadahiro Toda, Kenta Murakami, Masafumi Shoji, Masayasu Ohara, Chisato Tomita, Yoshitoshi Fukudo, Shin Ando, Tetsuya Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title | Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title_full | Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title_fullStr | Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title_full_unstemmed | Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title_short | Cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (IBS): protocol for a multicenter randomized controlled trial in Japan |
title_sort | cognitive behavioral therapy with interoceptive exposure and complementary video materials for irritable bowel syndrome (ibs): protocol for a multicenter randomized controlled trial in japan |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6551860/ https://www.ncbi.nlm.nih.gov/pubmed/31178921 http://dx.doi.org/10.1186/s13030-019-0155-2 |
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