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Trial registered on ANZCTR


Registration number
ACTRN12605000752662
Ethics application status
Approved
Date submitted
16/11/2005
Date registered
17/11/2005
Date last updated
22/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
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?
Scientific title
The course of inflammatory bowel disease, irritable bowel syndrome and hepatitis C in relation to psychological co-morbidity - a cohort prospective management trial.
Secondary ID [1] 281539 0
Psychological factors and response to medical treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease (IBD) 906 0
Irritable bowel syndrome (IBS) 907 0
Hepatitis C (HCV) 908 0
Condition category
Condition code
Oral and Gastrointestinal 973 973 0 0
Inflammatory bowel disease
Inflammatory and Immune System 974 974 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study was a cohort prospective management study. This design enabled a comparison of the rates of psychological disorders and quality of life in IBD, IBS and HCV patients over a one-year period. The study aimed to establish whether psychological co-morbidities affect the likelihood of a successful response to treatment.
Intervention code [1] 761 0
Behaviour
Comparator / control treatment
Irritable bowel syndrome and chronic hepatitis C patients were controls for inflammatory bowel disease
Control group
Active

Outcomes
Primary outcome [1] 1293 0
Proportion of time in clinical remission
Timepoint [1] 1293 0
Over the 12 month period
Primary outcome [2] 1294 0
Clearance of Hepatitis C
Timepoint [2] 1294 0
Over the 12 month period
Primary outcome [3] 1295 0
Proportion of IBS patients with sufficient relief of symptoms
Timepoint [3] 1295 0
After a year of standard therapy
Secondary outcome [1] 2322 0
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.
Timepoint [1] 2322 0
The secondary outcome was measured after 12 months

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1071 0
University
Name [1] 1071 0
Department of General Practice and the Department of Psychology, the University of Adelaide
Address [1] 1071 0
Eleanor Harrald Building, Frome Rd, Adelaide 5001
Country [1] 1071 0
Australia
Funding source category [2] 1072 0
Hospital
Name [2] 1072 0
Department of Gastroenterology, Hepatology and General Medicine, the Royal Adelaide Hospital
Address [2] 1072 0
North Tce, Adelaide 5000, SA
Country [2] 1072 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Department of General Practice and the Department of Psychology, the University of Adelaide, Eleanor Harrald Building, Frome Rd, Adelaide 5001
Country
Australia
Secondary sponsor category [1] 932 0
Hospital
Name [1] 932 0
Royal Adelaide Hospital
Address [1] 932 0
North Tce, Adelaide 5000, SA
Country [1] 932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2372 0
The Royal Adelaide Hospital Research Ethics Committee,
Ethics committee address [1] 2372 0
Ethics committee country [1] 2372 0
Australia
Date submitted for ethics approval [1] 2372 0
Approval date [1] 2372 0
Ethics approval number [1] 2372 0
Ethics committee name [2] 2373 0
The University of Adelaide Graduate Centre
Ethics committee address [2] 2373 0
Ethics committee country [2] 2373 0
Australia
Date submitted for ethics approval [2] 2373 0
Approval date [2] 2373 0
Ethics approval number [2] 2373 0

Summary
Brief summary
To observe and compare the course of IBD, IBS and hepatitis C in relation to psychological co-morbidity.
Trial website
Trial related presentations / publications
Mikocka-Walus, A., Turnbull, D., Andrews, J., Moulding, N., Wilson, I., Holtmann, G. (2008). Does psychological status influence clinical outcomes in patients
with inflammatory bowel disease (IBD) and other chronic gastroenterological
diseases? An observational cohort prospective study. BioPsychoSocial Medicine 6; 2(1):11
Public notes

Contacts
Principal investigator
Name 35314 0
Address 35314 0
Country 35314 0
Phone 35314 0
Fax 35314 0
Email 35314 0
Contact person for public queries
Name 9950 0
Dr Antonina Mikocka-Walus
Address 9950 0
School of Nursing and Midwiefery, University of South Australia, GPO Box 2471, Adelaide SA
Country 9950 0
Australia
Phone 9950 0
+61 8 83022468
Fax 9950 0
+61 8 83022168
Email 9950 0
antonina.mikocka-walus@unisa.edu.au
Contact person for scientific queries
Name 878 0
Dr Antonina Mikocka-Walus
Address 878 0
School of Nursing and Midwiefery, University of South Australia, GPO Box 2471, Adelaide SA
Country 878 0
Australia
Phone 878 0
+61 8 83022468
Fax 878 0
+61 8 83022168
Email 878 0
antonina.mikocka-walus@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary