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ISRCTN
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ISRCTN51405816
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ClinicalTrials.gov identifier
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Public title
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Cognitive behavioural therapy versus antispasmodic therapy for irritable bowel syndrome in primary care
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 96/13/04
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive system diseases: Inflammatory bowel disease
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Participants - inclusion criteria
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Patients with irritable bowel syndrome
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/02/1999
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Anticipated end date
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31/12/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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130
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://gppc.kcl.ac.uk/report/study.asp?id=36
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16093252
2. 2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16729918
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Contact name
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Dr
Thomas
Kennedy
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Address
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Department of General Practice
UMDS (Guy's and St. Thomas's)
5 Lambeth Walk
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City/town
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London
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Zip/Postcode
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SE11 6SP
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Country
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United Kingdom
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Tel
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+44 (0)20 7735 8881 x 231
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Fax
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+44 (0)20 7793 7232
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Email
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t.kennedy@umds.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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17/12/2008
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Date ISRCTN assigned
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25/04/2003
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