ISRCTN ISRCTN81183509
DOI https://doi.org/10.1186/ISRCTN81183509
Protocol serial number N/A
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive North West (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
15/11/2011
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

Contact information

Dr Elspeth Guthrie
Scientific

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone +44 (0)161 276 5382

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInflammatory bowel disease
InterventionPsychotherapeutic intervention plus standard medical treatment versus standard medical treatment plus supportive listening.
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/1993

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteria1. 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
Key exclusion criteriaSevere depression with suicidal ideas
Date of first enrolment01/04/1992
Date of final enrolment31/05/1993

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2001 Yes No