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ACTIB: Assessing Cognitive behavioural Therapy in Irritable Bowel

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44427879
Enrollment
495
Registered
2013-11-18
Start date
2014-05-01
Completion date
Unknown
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care Research Network for England, Oral and Gastrointestinal

Interventions

495 participants with refractory IBS will be randomised to a high-intensity therapist-delivered CBT (TCBT) + treatment as usual (TAU), or a lower intensity web-based CBT programme (LIBT) + TAU, or TAU

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026