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Trial registered on ANZCTR


Registration number
ACTRN12605000751673
Ethics application status
Approved
Date submitted
16/11/2005
Date registered
17/11/2005
Date last updated
13/11/2012
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 disease?
Scientific title
Does the disclosure of the inflammatory bowel disease patient's
psychological status to their physician influences patient's
responses to the clinical treatment?: The randomized controlled
trial with Royal Adelaide Hospital gastroenterologists.
Secondary ID [1] 281540 0
RCT on disclosure of psychological status of IBD patients to doctors
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 905 0
Condition category
Condition code
Oral and Gastrointestinal 972 972 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 760 0
Behaviour
Comparator / control treatment
The psychological status of patients assigned to the control group will not be disclosed to the treating physician. 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.
Control group
Active

Outcomes
Primary outcome [1] 1292 0
The primary outcome will be remission of inflammatory bowel disease defined as 3
weeks of Crohn's disease activity < 150 points (Crohn's Disease Activity Index) or a
drop in the score of at least 70 points, and ulcerative colitis activity < 2 (Simple
Clinical Colitis Activity Index) or a drop in the score of at least 3 points.
Timepoint [1] 1292 0
Measured each 3 months for a year.
Secondary outcome [1] 2321 0
The secondary outcome will be a remission of a psychological disorder and improved quality of life. A score between 0-7 on
the Hospital Anxiety and Depression Scale (HADS) or a drop of one category will be marked as improvement of
psychological disorders. A change on SCL-90-R will confirm the result on HADS. In general, respondents who score > 11 on
either subscale of HADS have a probable psychiatric disorder (Zigmond and Snaith 1983).
The change in quality of life will be noted on the SF-12 scale.
Timepoint [1] 2321 0
The outcome will be measured each 3 months for a year.

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 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with diagnosed psychological disorders will be allocated into two groups. The psychological status of patients assigned to the experimental group will be randomly disclosed to the treating physicians. The psychological status of patients assigned to the control group will not be disclosed to the treating physician. The psychological status of any patient diagnosed with severe psychological disorder (i.e. psychosis, severe depression) will be reported to his/her doctor irrespective of which experimental group the subject is assigned to. The treatment approach will be at the physicians discretion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number tables will be used to generate a randomisation schedule. Allocation to study group will be via a preorganised sequence of sealed envelopes each containing the questionnaires for the next follow-up.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1069 0
University
Name [1] 1069 0
Department of General Practice and the Department of Psychology, the University of Adelaide
Country [1] 1069 0
Australia
Funding source category [2] 1070 0
Hospital
Name [2] 1070 0
Department of Gastroenterology, Hepatology and General Medicine, the Royal Adelaide Hospital
Country [2] 1070 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Department of General Practice and the Department of Psychology, the University of Adelaide, Frome Rd, Adelaide 5001, SA
Country
Australia
Secondary sponsor category [1] 931 0
Hospital
Name [1] 931 0
Royal Adelaide Hospital
Address [1] 931 0
North Tce, Adelaide 5000, SA
Country [1] 931 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2370 0
The Royal Adelaide Hospital Research Ethics Commiittee,
Ethics committee address [1] 2370 0
Ethics committee country [1] 2370 0
Australia
Date submitted for ethics approval [1] 2370 0
Approval date [1] 2370 0
Ethics approval number [1] 2370 0
Ethics committee name [2] 2371 0
The University of Adelaide Graduate Studies Centre
Ethics committee address [2] 2371 0
Ethics committee country [2] 2371 0
Australia
Date submitted for ethics approval [2] 2371 0
Approval date [2] 2371 0
Ethics approval number [2] 2371 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36296 0
Address 36296 0
Country 36296 0
Phone 36296 0
Fax 36296 0
Email 36296 0
Contact person for public queries
Name 9949 0
Dr Antonina Mikocka-Walus
Address 9949 0
University of South Australia, Nursing, GPO Box 2471, Adelaide 5001, SA
Country 9949 0
Australia
Phone 9949 0
+61 8 83022468
Fax 9949 0
+61 8 83022168
Email 9949 0
antonina.mikocka-walus@unisa.edu.au
Contact person for scientific queries
Name 877 0
Dr Antonina Mikocka-Walus
Address 877 0
University of South Australia, Nursing, GPO Box 2471, Adelaide 5001, SA
Country 877 0
Australia
Phone 877 0
+61 8 83022468
Fax 877 0
+61 8 83022168
Email 877 0
antonina.mikocka-walus@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.