Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000922875
Ethics application status
Approved
Date submitted
29/08/2012
Date registered
29/08/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Computerised psychoeductional intervention for inflammatory bowel disease
Scientific title
Effect of a computerised psychoeducational intervention on quality of life in people with inflammatory bowel disease.
Secondary ID [1] 281117 0
Nil known
Universal Trial Number (UTN)
U1111-1133-9642
Trial acronym
CCBT4IBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 287279 0
Depression 287280 0
Anxiety 287281 0
Condition category
Condition code
Mental Health 287604 287604 0 0
Depression
Mental Health 287605 287605 0 0
Anxiety
Oral and Gastrointestinal 287606 287606 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The computerised psychoeducation will cover a number of topics: goal setting; thoughts feelings and behaviours; avoiding avoidance; coping styles; diet; effective communication; pain management; and relapse prevention. Patients will be given up to 12 weeks to complete the 8 one hour sessions; this is to allow for the effects of holidays, busy schedules, etc. to be nullified by people being given opportunities to “catch up”. Cognitive behavioural therapy techniques are used as part of the intervention.
Intervention code [1] 285573 0
Treatment: Other
Intervention code [2] 285574 0
Behaviour
Comparator / control treatment
Treatment as usual. Those allocated to the treatment as usual group will receive usual care (i.e. not have any treatment withheld aside from the computerised psychoeducation).
Control group
Active

Outcomes
Primary outcome [1] 287867 0
Inflammatory Bowel Disease Quality of Life will be measured using the Inflammatory Bowel Disease Questionnaire (IBDQ).
Timepoint [1] 287867 0
Baseline, post intervention (12 weeks), 6 months post intervention, and 12 months post intervention.
Secondary outcome [1] 298958 0
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) .
Timepoint [1] 298958 0
Baseline, post intervention (12 weeks), 6 months post intervention, and 12 months post intervention.
Secondary outcome [2] 298959 0
Depression will be measured using the Hospital Anxiety and Depression (HADS).
Timepoint [2] 298959 0
Baseline, post intervention (12 weeks), 6 months post intervention, and 12 months post intervention.
Secondary outcome [3] 298960 0
Medical Costs will be measured at 12 months by examining patient notes and allocating amounts to outpatient clinic visits, hospital stays, number of procedures, medication use, and so forth.
Timepoint [3] 298960 0
12 months
Secondary outcome [4] 298961 0
Coping will be measured using the Brief COPE and the IBD Cope.
Timepoint [4] 298961 0
Baseline, post intervention (12 weeks), 6 months post intervention, and 12 months post intervention.
Secondary outcome [5] 298962 0
Generic quality of life will be measured using the SF-12.
Timepoint [5] 298962 0
Baseline, post intervention (12 weeks), 6 months post intervention, and 12 months post intervention.

Eligibility
Key inclusion criteria
Patients will be prescreened to see whether they meet the inclusion criteria of the study, which includes age 18-65, IBD diagnosis, willingness to participate, adequate computer literacy.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe disease, significant cognitive deficit, previous exposure to Cognitive Behavioural Therapy, and severe physical or psychiatric comorbidity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be approached in person and asked whether they are interested in participating in the study. They will also be screened to ensure they meet inclusion/exclusion criteria. If they show interest and meet the criteria, then they will be presented with an information sheet and consent form and have the study explained to them in lay terms. The consent form will give them an option to either opt in or opt out of the study. They will have the option of consenting at that time or deciding later.
Patients will be screened before they are randomized which means that when the decision is made regarding their inclusion/exclusion, the person making this decision will be unaware of which group the subject will be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program provided by John Pearson (biostatistian) will be used to randomise the subjects
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/11/2012
Actual
29/10/2012
Date of last participant enrolment
Anticipated
Actual
2/10/2013
Date of last data collection
Anticipated
Actual
2/10/2014
Sample size
Target
240
Accrual to date
Final
199
Recruitment outside Australia
Country [1] 4516 0
New Zealand
State/province [1] 4516 0
Canterbury

Funding & Sponsors
Funding source category [1] 285897 0
University
Name [1] 285897 0
University of Otago, Christchurch
Country [1] 285897 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 284720 0
Charities/Societies/Foundations
Name [1] 284720 0
Todd Foundation
Address [1] 284720 0
Postal Address: PO Box 3142

Street Address: L14, Todd Building, 95 Customhouse Quay

Wellington 6011

New Zealand
Country [1] 284720 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287926 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 287926 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 287926 0
New Zealand
Date submitted for ethics approval [1] 287926 0
29/08/2012
Approval date [1] 287926 0
19/10/2012
Ethics approval number [1] 287926 0

Summary
Brief summary
In this study, we will be randomizing 238 inflammatory bowel disease (IBD) patients to either an 8 session course of a computerised psychoeducational intervention or treatment as usual (TAU). The psychoeducation will cover a number of topics: goal setting; thoughts feelings and behaviours; avoiding avoidance; coping styles; diet; effective communication; pain management; and relapse prevention. Patients will be given up to 12 weeks to complete the 8 sessions; this is to allow for the effects of holidays, busy schedules, etc. to be nullified by people being given opportunities to “catch up”. We will be recruiting more patients into psychoeducation (n=126) than TAU (n=112) because we have been told by researchers who have done a similar study in Adelaide that we can expect more people to drop out of the computerised psychoeducation group. We will be measuring anxiety, depression, quality of life (QOL), coping styles, and IBD symptoms at baseline and obtaining demographic information (with patients’ consent) from the Concierto Patient Management System. We will also be measuring anxiety, depression, QOL, coping styles, and IBD symptoms post intervention in the psychoeducation group and at the 12-week equivalent in the TAU group. In addition, we will measure patient perceptions of the computerised psychoeducation program by asking such questions as whether they found the computerised psychoeducation relevant, valid, and effective. Perhaps our most important measure will come at 12 months post-intervention, when we will be asking patients about the abovementioned variables and also measuring whether direct medical costs have been reduced through less outpatient visits and hospitalizations in the psychoeducation group.
Trial website
Trial related presentations / publications
1. McCombie, Andrew, Gearry, Richard, Andrews, Jane et al. (2 more authors) (2016) Does
Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel
Disease? : A Randomized Controlled Trial. Inflammatory bowel diseases. pp. 171-181.
ISSN 1536-4844
2. McCombie A, Gearry R, Mulder R, Andrews J, and Mikocka-Walus A. Does computerised cognitive behavioural therapy help people with inflammatory bowel disease? A randomized controlled trial. The 10th Annual Conference of the European Crohn’s and Colitis Organisation, Barcelona, Spain, 18-21 February, 2015.
3. McCombie A, Gearry R, Mulder R, Andrews J, and Mikocka-Walus A. Does computerised cognitive behavioural therapy help people with inflammatory bowel disease? A randomized controlled trial. The New Zealand Society of Gastroenterology Annual Scientific Meeting 2014, Auckland, New Zealand, 27-29 November, 2014. (Winner of Best luminal poster/paper)
Public notes

Contacts
Principal investigator
Name 34636 0
Dr Dr Andrew McCombie
Address 34636 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 34636 0
New Zealand
Phone 34636 0
+64272626111
Fax 34636 0
Email 34636 0
[email protected]
Contact person for public queries
Name 17883 0
Dr Andrew McCombie
Address 17883 0
PO Box 4345
Department of Medicine
University of Otago
Christchurch 8140
Country 17883 0
New Zealand
Phone 17883 0
+64 3 3786305
Fax 17883 0
Email 17883 0
[email protected]
Contact person for scientific queries
Name 8811 0
Dr Andrew McCombie
Address 8811 0
PO Box 4345
Department of Medicine
University of Otago
Christchurch 8140
Country 8811 0
New Zealand
Phone 8811 0
+64 3 3786305
Fax 8811 0
Email 8811 0
[email protected]

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
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Documents added automatically
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