Cargando…

Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)

INTRODUCTION: Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and d...

Descripción completa

Detalles Bibliográficos
Autores principales: Löwe, Bernd, Nestoriuc, Yvonne, Andresen, Viola, Vettorazzi, Eik, Zapf, Antonia, Hübener, Sina, Maehder, Kerstin, Peters, Luisa, Lohse, Ansgar W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9198710/
https://www.ncbi.nlm.nih.gov/pubmed/35701050
http://dx.doi.org/10.1136/bmjopen-2021-059529
_version_ 1784727686531252224
author Löwe, Bernd
Nestoriuc, Yvonne
Andresen, Viola
Vettorazzi, Eik
Zapf, Antonia
Hübener, Sina
Maehder, Kerstin
Peters, Luisa
Lohse, Ansgar W
author_facet Löwe, Bernd
Nestoriuc, Yvonne
Andresen, Viola
Vettorazzi, Eik
Zapf, Antonia
Hübener, Sina
Maehder, Kerstin
Peters, Luisa
Lohse, Ansgar W
author_sort Löwe, Bernd
collection PubMed
description INTRODUCTION: Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. METHODS AND ANALYSIS: To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies. TRIAL REGISTRATION NUMBER: ISRCTN30800023.
format Online
Article
Text
id pubmed-9198710
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-91987102022-07-08 Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT) Löwe, Bernd Nestoriuc, Yvonne Andresen, Viola Vettorazzi, Eik Zapf, Antonia Hübener, Sina Maehder, Kerstin Peters, Luisa Lohse, Ansgar W BMJ Open Gastroenterology and Hepatology INTRODUCTION: Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. METHODS AND ANALYSIS: To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies. TRIAL REGISTRATION NUMBER: ISRCTN30800023. BMJ Publishing Group 2022-06-14 /pmc/articles/PMC9198710/ /pubmed/35701050 http://dx.doi.org/10.1136/bmjopen-2021-059529 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Gastroenterology and Hepatology
Löwe, Bernd
Nestoriuc, Yvonne
Andresen, Viola
Vettorazzi, Eik
Zapf, Antonia
Hübener, Sina
Maehder, Kerstin
Peters, Luisa
Lohse, Ansgar W
Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title_full Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title_fullStr Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title_full_unstemmed Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title_short Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
title_sort persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (soma.gut-rct)
topic Gastroenterology and Hepatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9198710/
https://www.ncbi.nlm.nih.gov/pubmed/35701050
http://dx.doi.org/10.1136/bmjopen-2021-059529
work_keys_str_mv AT lowebernd persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT nestoriucyvonne persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT andresenviola persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT vettorazzieik persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT zapfantonia persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT hubenersina persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT maehderkerstin persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT petersluisa persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct
AT lohseansgarw persistenceofgastrointestinalsymptomsinirritablebowelsyndromeandulcerativecolitisstudyprotocolforathreearmrandomisedcontrolledtrialsomagutrct