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Cognitive behavioural therapy - irritable bowel syndrome feasibility study

A mixed methods feasibility study to evaluate the use of low-intensity, nurse-delivered cognitive behavioural therapy in the treatment of irritable bowel syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83683687
Enrollment
60
Registered
2014-01-27
Start date
2014-01-30
Completion date
Unknown
Last updated
2018-12-10

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

Conditions

Irritable Bowel Syndrome Digestive System Irritable bowel syndrome

Interventions

Participants in each of the study conditions will have measures taken at baseline and at 12 and 26 weeks post randomisation. Participants will be randomly allocated to one of four treatment conditions

Sponsors

University of Nottingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult male and female patients aged 18 years or older at the time of enrolment 2. Documented medical diagnosis of IBS with symptom onset at least six months prior to recruitment (in order to fulfil Rome criteria at screening) 3. Able to read, write and speak the English language 4. Able to provide written informed consent 5. Patients with and without concomitant antidepressant use 6. Not currently taking part in other research studies 7. Able to commit to weekly treatment sessions within the intervention arms of the study

Exclusion criteria

Exclusion criteria: 1. Already receiving psychological therapy or hypnotherapy 2. Existing diagnosis of bowel disease based on endoscopic or histologic criteria (i.e., Crohn's disease, ulcerative colitis, coeliac disease) 3. Presence or history of structural or surgical diseases of the GI tract (not including appendix or gall bladder surgery) 4. Evidence of alcohol or substance misuse 5. An established cause for bowel symptoms other than IBS (i.e., medication use) 6. The presence of suicidal ideation (current intent/plans/actions) or self-harm (current intent/plans/actions). 7. Significant psychiatric co-morbidity (schizophrenia, bipolar disorder, obsessive-compulsive disorder [OCD])

Design outcomes

Primary

MeasureTime frame
Gastrointestinal Symptom Rating Scale for IBS (IBS-GSRS) measured at baseline, 12 weeks and 26 weeks post randomisation.

Secondary

MeasureTime frame
1. Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) 2. Generalised Anxiety Disorder Assessment (GAD 7) 3. Patient Health Questionnaire (PHQ-9) Measured at baseline, 12 weeks and 26 weeks post randomisation.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026