Cognitive behavioural therapy versus antispasmodic therapy for irritable bowel syndrome in primary care
| ISRCTN | ISRCTN51405816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51405816 |
| Secondary identifying numbers | HTA 96/13/04 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Kennedy
Scientific
Scientific
Department of General Practice
UMDS (Guy's and St. Thomas's)
5 Lambeth Walk
London
SE11 6SP
United Kingdom
| Phone | +44 (0)20 7735 8881 x 231 |
|---|---|
| t.kennedy@umds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Some patients with irritable bowel syndrome (IBS) do not benefit from explanation, reassurance and symptomatic management and develop a chronic illness with high health care costs. This study is designed to establish whether early intervention with CBT is advantageous over current treatment. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Digestive system diseases: Inflammatory bowel disease |
| Intervention | Please note that, as of 15 January 2008, the start and end dates of this trial have been updated from 1 January 1999 and 31 December 2001 to 1 February 1999 and 31 December 2002, respectively. Interventions: The trial is divided into 4 stages: Stage 1: Consecutive IBS patients presenting to their GP will be considered for the study. Patients will receive standardised first line assessment including symptom explanation, advice and treatment in order to identify those who respond to 'usual measures'. Stage 2: Those patients remaining symptomatic after two weeks will be given treatment with mebeverine hydrochloride, which is the most commonly used antispasmodic in the UK. We will interview patients at this stage to elicit their coping strategies. Stage 3: After a further four weeks patients still symptomatic will be randomised to receive 6 sessions of cognitive behavioural therapy plus mebeverine hydrochloride (n=65) or continue on mebeverine hydrochloride alone (n=65). Stage 4: Nine weeks after randomisation patients will be assessed for improvement with further assessments 3, 6 and 12 months after completing treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mebeverine |
| Primary outcome measure | IBS Severity Scoring System (SSS), Hospital Anxiety and Depression Scale, Social Adjustment Scale, Illness Perception Questionnaire (IPQ) and a modified version of the Client Services Receipt Inventory (CSRI). The principle outcome will be the degree of improvement on the SSS. We will perform an economic analysis using the CSRI. An IBS specific coping questionnaire will be devised to identify successful coping in IBS and will be complemented by the IPQ and by qualitative interviews. A subsidiary outcome will be an evaluated and accredited training course equipping primary care nurses with skills in generic and IBS specific CBT. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/02/1999 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | Patients with irritable bowel syndrome |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/02/1999 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Practice
London
SE11 6SP
United Kingdom
SE11 6SP
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/08/2005 | Yes | No | |
| Other publications | HTA monograph | 01/06/2006 | Yes | No |
