Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Thomas Kennedy
ORCID ID
Contact details
Department of General Practice
UMDS (Guy's and St. Thomas's)
5 Lambeth Walk
London
SE11 6SP
United Kingdom
+44 (0)20 7735 8881 x 231
t.kennedy@umds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/13/04
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/1999
Overall trial end date
31/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with irritable bowel syndrome
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/02/1999
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Practice
London
SE11 6SP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
HTA monograph
Kennedy TM, Chalder T, McCrone P, Darnley S, Knapp M, Jones RH, Wessely S, Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial., Health Technol Assess, 2006, 10, 19, iii-iv, ix-x, 1-67.
-
Kennedy T, Jones R, Darnley S, Seed P, Wessely S, Chalder T, Cognitive behaviour therapy in addition to antispasmodic treatment for irritable bowel syndrome in primary care: randomised controlled trial., BMJ, 2005, 331, 7514, 435, doi: 10.1136/bmj.38545.505764.06.