ISRCTN44427879
Unknown
未知
ACTIB: (Assessing Cognitive behavioural Therapy in Irritable Bowel): a randomised controlled trial of clinical and cost effectiveness of therapist-delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome
niversity of Southampton (UK)0 sites558 target enrollmentNovember 18, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Disease: All Diseases, Gastrointestinal
- Sponsor
- niversity of Southampton (UK)
- Enrollment
- 558
- Last Updated
- 4 years ago
Overview
Brief Summary
2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26179651 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29508539 qualitative study results 2019 Abstract results in https://www.ncbi.nlm.nih.gov/pubmed/31042143 results abstract (added 02/05/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31492643 results (added 09/09/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30971419 results (added 27/09/2019) 2019 Results article in http://dx.doi.org/10.1136/gutjnl-2018-317805 RCT results (added 04/11/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults (male and female, 18 years and over) with refractory IBS (clinically significant symptoms defined by a IBS\-SSS i.e. \>75\)
- •2\. Fulfilling ROME III criteria and who have been offered first\-line therapies (e.g. anti\-spasmodics, anti\-depressants or fibre\-based medications) but still have continuing IBS symptoms for 12 months or more
Exclusion Criteria
- •Current exclusion criteria as of 05/12/2013:
- •1\. Unexplained rectal bleeding or weight loss
- •2\. Diagnosis of inflammatory bowel disease, coeliac disease, peptic ulcer disease or colorectal carcinoma
- •3\. Unable to participate in CBT due to speech or language difficulties
- •4\. No access to an internet computer to be able to undertake the low intensity CBT, previous access to the MIBS website, received CBT for IBS in the last two years
- •Previous exclusion criteria:
- •1\. Unexplained rectal bleeding or weight loss
- •2\. Diagnosis of inflammatory bowel disease, coeliac disease, peptic ulcer disease or colorectal carcinoma
- •3\. Unable to participate in CBT due to speech or language difficulties
- •4\. No access to an internet computer to be able to undertake the low intensity CBT or previous participation in the MIBS study
Outcomes
Primary Outcomes
Not specified
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