Psychological factors and response to medical treatment:Do psychological factors determine the outcome in patients with inflammatory bowel disorders and other common gastrointestinal and hepatologic disorders?

Not Applicable

Completed

• Conditions: Inflammatory bowel disease (IBD); Irritable bowel syndrome (IBS); Hepatitis C (HCV); Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Liver

• Registration Number: ACTRN12605000752662
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Participants who visit the Department of Gastroenterology in Royal Adelaide Hospital (RAH) between November 2005 and April 2006 will be recruited consecutively by their doctors from IBD, IBS and Hepatitis C outpatients. Patients will be informed about the research and written consent will be obtained. Inclusion criteria Patients included into studies must satisfy any one of 1-3 AND both of 4 & 5(1) Patients with IBD (Crohns disease or ulcerative colitis) diagnosed by clinical, endoscopic, histologic and/or radiologic criteria; (2) Patients with IBS diagnosed by clinical, endoscopic, histologic and/or radiologic criteria;(3) Patients diagnosed serologically with hepatitis C;(4) Patients with sufficient knowledge of English to understand and answer questionnaires;(5) Patients who sign written informed consent.

Exclusion Criteria

(1) Patients with insufficient knowledge of English or who are cognitively impaired, as the study requires filling in and understanding questionnaires written in English;(2) Patients who do not give informed consent;(3) Hepatitis C patients with cirrhosis (other than Childs A) or cancer of the liver as, this may be confounding psychological factors, due to disease severity/known effect on mortality.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of time in clinical remission[Over the 12 month period];Clearance of Hepatitis C[Over the 12 month period];Proportion of IBS patients with sufficient relief of symptoms[After a year of standard therapy]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was an improvement of the psychological status and the quality of life measured on the Hospital Anxiety and Depression Scale, SCL90 and SF-12.[The secondary outcome was measured after 12 months]