Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Not Specified
Patient information sheet
Condition
Inflammatory bowel disease
Intervention
Psychotherapeutic intervention plus standard medical treatment versus standard medical treatment plus supportive listening.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1992
Overall trial end date
31/05/1993
Reason abandoned
Eligibility
Participant inclusion criteria
1. Abdominal pain
2. Abdominal distention
3. Abnormal bowel habit associated with normal haematology, serum biochemistry, rectal biopsy and colonoscopy
4. Patients must have had symptoms for at least a year
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Severe depression with suicidal ideas
Recruitment start date
01/04/1992
Recruitment end date
31/05/1993
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (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
1993 results in http://www.ncbi.nlm.nih.gov/pubmed/11346322
Publication citations
-
Results
Creed F, Ratcliffe J, Fernandez L, Tomenson B, Palmer S, Rigby C, Guthrie E, Read N, Thompson D, Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome., Ann. Intern. Med., 2001, 134, 9 Pt 2, 860-868.