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

Study website

Contact information

Dr Thomas Kennedy
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
Email t.kennedy@umds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesSome 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) studiedDigestive system diseases: Inflammatory bowel disease
InterventionPlease 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Mebeverine
Primary outcome measureIBS 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 measuresNot provided at time of registration.
Overall study start date01/02/1999
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants130
Key inclusion criteriaPatients with irritable bowel syndrome
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/02/1999
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of General Practice
London
SE11 6SP
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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