Psychological factors and response to medical treatment: Do psychological factors determine the outcome in patients with inflammatory bowel disease?

Not Applicable

Completed

• Conditions: Inflammatory bowel disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12605000751673
• 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: 65

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 outpatients. Patients will be informed about the research and written consent will be obtained. Inclusion criteria (1)Patients with IBD (Crohn's disease or ulcerative colitis) diagnosed by clinical, endoscopic, histologic and/or radiologic criteria; (2)Patients with sufficient knowledge of English to understand and answer questionnaires;(3)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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be remission of inflammatory bowel disease defined as 3 <br>weeks of Crohn's disease activity < 150 points (Crohn's Disease Activity Index) or a <br>drop in the score of at least 70 points, and ulcerative colitis activity < 2 (Simple <br>Clinical Colitis Activity Index) or a drop in the score of at least 3 points. [Measured each 3 months for a year.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be a remission of a psychological disorder and improved quality of life. A score between 0-7 on <br>the Hospital Anxiety and Depression Scale (HADS) or a drop of one category will be marked as improvement of <br>psychological disorders. A change on SCL-90-R will confirm the result on HADS. In general, respondents who score > 11 on <br>either subscale of HADS have a probable psychiatric disorder (Zigmond and Snaith 1983).<br>The change in quality of life will be noted on the SF-12 scale.[The outcome will be measured each 3 months for a year.]