Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://gppc.kcl.ac.uk/report/study.asp?id=36

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes