None listed
Conditions
Brief summary
To discover whether disclosure of the psychological status of inflammatory bowel disease patients to their physicians influences patients responses to treatment.
Interventions
The psychological status of patients assigned to the experimental group will be disclosed to the treating physicians. However, any patient diagnosed with severe psychological disorder (i.e. psychosis, severe depression) will be reported to his/her doctor irrespective of the
process of randomisation.
Study will be a randomized controlled trial examining whether disclosure of IBD patients' psychological status to
their physician influences patients' responses to the clinical treatment. IBD pat
The psychological status of patients assigned to the experimental group will be disclosed to the treating physicians. However, any patient diagnosed with severe psychological disorder (i.e. psychosis, severe depression) will be reported to his/her doctor irrespective of the process of randomisation. Study will be a randomized controlled trial examining whether disclosure of IBD patients' psychological status to their physician influences patients' responses to the clinical treatment. IBD patients will all receive current standard medical care. In addition, they will fill in questionnaires measuring their disease activity, quality of life and psychological status. Participants with diagnosed psychological disorders detected by the screening instruments (HADS, SCL90) will be randomly allocated into one of two groups. As psychological co-morbidities in patients with IBD are frequently unrecognised in standard care settings, and often not specifically treated; this methodology should reveal whether a physician's knowledge of the patient's mental health status influences the physician's actions or the patient's response to clinical treatment. Study will be prospective with follow-up every 3 months for a year.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
Outcome results
None listed