ACTIB: Assessing Cognitive behavioural Therapy in Irritable Bowel

Not Applicable

• Conditions: Topic: Primary Care Research Network for England, Oral and Gastrointestinal; Subtopic: Not Assigned, Oral and Gastrointestinal (all Subtopics); Disease: All Diseases, Gastrointestinal; Digestive System; Irritable bowel syndrome

• Registration Number: ISRCTN44427879
• Lead Sponsor: niversity of Southampton (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Study Completion: 2016-02-29
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 05/12/2013:<br> 1. IBS Symptom Severity Score (IBS SSS)<br> 2. Work and Social Adjustment Scale (WASAS)<br> Timepoint(s): 3, 6 and 12 months<br><br> Previous primary outcome measures:<br> 1. The Subjects Global Assessment of Relief (SGA of Relief)<br> 2. IBS Symptom Severity Score (IBS SSS)<br> Timepoint(s): 3, 6 and 12 months<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures