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Trial registered on ANZCTR


Registration number
ACTRN12609000913279
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
21/10/2009
Date last updated
14/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? A pilot randomised controlled trial
Scientific title
Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? A pilot randomised controlled trial
Secondary ID [1] 253252 0
CBT and IBD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease (IBD) 251975 0
Condition category
Condition code
Oral and Gastrointestinal 252165 252165 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preliminary screening of interested subjects will ensure that patients who have an existing psychotic disorder or are currently receiving any form of psychotherapy, or are alcohol or substance dependant as assessed by their treating clinician or the investigators are excluded from both groups (by notes review, discussion with treating doctor, and by checklist of questions to subjects). Subjects will then be randomised to either the CBT or standard care group. Patients in the CBT group will be offered a choice between a face-to-face therapy and online therapy. All participants randomised to the CBT group will then have a screening interview with a Clinical Psychologist to assess suitability for CBT before the beginning of the trial. Moreover, patients will need to be available to attend the 2-hour 10 week group program (1 x 2 hour session per week) at the RAH or complete online exercises under the guidance of Senior Clinical Psychologist in a similar format to face-to-face sessions and agree to complete questionnaires at baseline, (10 weeks), 6, 12 and 24 months. Patients will be required to provide written informed consent before the beginning of the trial. CBT and standard care groups will have separate patient information sheets. The CBT will be a group program designed specifically for this patient population. It will be delivered in two modes, face-to-face and online providing a patient with a choice, with both following exactly the same program. Online CBT will have a weekly chat option and option to exchange emails with a Senior Clinical Psychologist built-in, in order to provide the opportunity to interact with the therapist mirroring face-to-face group’s mode. CBT is a form of psychotherapy that aims to identify and modify unhelpful negative thinking styles and the maladaptive behaviors associated with those thinking styles. The CBT intervention will also comprise elements of education about IBD and psychoeducation in addition to relaxation. The 10 week program will consist of:

Session 1: Education about CBT, IBD (gastroenterologists from the clinic will be facilitating the part on IBD). Psycho-education about stress responses and stress management techniques. Breathing control excercises.
Session 2: Stress and Awareness. Introduction to relaxation techniques.
Session 3: Automatic thoughts and cognitive distortions. Becoming aware of negative thinking patterns, learning to recognize anxiety-producing appraisals.
Session 4: Cognitve restructuring: Replacing distorted thinking with more rational and balanced thoughts.
Session 5. Exposure and overcoming avoidance. Planning and increasing activities.
Session 6. Introducation to coping strategies. Mindfulness exercise. Goal setting.
Session 7. Assertivness training. Developing awareness of unpleasant feelings (i.e. anger) and changing maladaptive patterns.
Session 8. Social support. Relationships and Communciation. Increasing communication around sensitve topics (i.e. sexuality).
Session 9. Attention and Distraction techniques.
Session 10. Relapse prevention. Predict problems for the future. Reinforce plan to use coping skills and reassess physical illness narrative using new skills learned.

The program can be accessed via: http://www.tameyourgut.com/

Attendance at each weekly session will be noted and patients that did not attend at least 5 sessions will be excluded from the main analysis.

At baseline and at the end of the final group session (10 weeks) questionnaires will be handed in to participants. Follow-up questionnaires (6, 12 and 24 months) as well as all the assessments in the control group will be conducted while participants visit the clinic for a blood test. Patients will be reminded about their scheduled blood tests and will be sent a referral.
Intervention code [1] 241385 0
Other interventions
Comparator / control treatment
Gastroenterology IBD patients

The control group will receive standard medical care, and also be asked to have all study bloods, disease activity indices, psychological assessments and QoL measures performed at baseline, 6 and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 253035 0
Disease-specific activity indices will be measured with Crohns Disease Activity Index (CDAI) or the Simple Clinical Colitis Activity Index (SCCAI).
Timepoint [1] 253035 0
10 weeks, 6 months, 12 months and 24 months from baseline
Primary outcome [2] 253036 0
Screening for anxiety and depression will be undertaken with the Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 253036 0
10 weeks, 6 months, 12 months and 24 months from baseline
Primary outcome [3] 253037 0
Screening for psychological coping will be conducted with the Brief COPE questionnaire
Timepoint [3] 253037 0
10 weeks, 6 months, 12 months and 24 months from baseline
Primary outcome [4] 253038 0
The inflammation parameters (cytokines and chemokines) C-reactive protein
(CRP), Interferon (IFN) gamma, Interleukin (IL) 1, 6, 10, 13 and 23, Tumor necrosis factor (TNF) alpha
Timepoint [4] 253038 0
10 weeks, 6 months, 12 months and 24 months from baseline
Primary outcome [5] 253039 0
The Short Form 36 Health Status Questionnaire (SF-36) will be used to measure Health-Related Quality of Life (HRQOL)
Timepoint [5] 253039 0
10 weeks, 6 months, 12 months and 24 months from baseline
Primary outcome [6] 253040 0
The State-Trait Anxiety Inventory (STAI) will be used to differentiate between different forms of anxiety
Timepoint [6] 253040 0
10 weeks, 6 months, 12 months and 24 months from baseline
Secondary outcome [1] 257852 0
Nil
Timepoint [1] 257852 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria: Patients have to meet ALL of the following criteria: 1). Have a clinically established diagnosis of IBD; 2). Be in clinical remission or have mild symptoms only of IBD for at least 3 months as evidenced by disease activity index, notes review, blood results and report from their treating gastroenterologist, if necessary; 3). Have a sufficient knowledge of English to understand and answer questionnaires and participate in the therapy; 4). Be 18 years old or older; 5). Have the ability to consent to the study.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have an existing psychotic disorder or are currently receiving any form of psychotherapy, or are alcohol or substance dependant

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)
After preliminary screening (as described above), permuted blocks will be used to allocate patients to either the CBT or usual care (control) group. After each 20 subjects are randomised, groups will be reviewed to ensure they are similar with respect to demographics and IBD subtype. If groups are found to differ greatly the process will be repeated until they are more similar in these characteristics. Randomisation will be conducted by a researcher with no direct patient contact (AMW). Complete blinding of patients is not possible. However, the control group will not be informed that an experimental group receives the intervention. Moreover, all treating gastroenteroligists will be blinded to whether patients receive an intervention or standard treatment, and patients will be asked to refrain from specifically discussing it with their Gastroenterologists unless they specifically wish to discuss concerns arising from the sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation method was used using a table of computer generated random numbers in the proportion of 2:1 (experimental vs. control).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
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)
SA
Recruitment hospital [1] 5621 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 5622 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 243849 0
Charities/Societies/Foundations
Name [1] 243849 0
Crohn's and Colitis of Australia
Address [1] 243849 0
Melbourne, VIC
Country [1] 243849 0
Australia
Funding source category [2] 286093 0
Commercial sector/Industry
Name [2] 286093 0
Abbott Australia
Address [2] 286093 0
Sydney, NSW
Country [2] 286093 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 237198 0
None
Name [1] 237198 0
Nil
Address [1] 237198 0
Nil
Country [1] 237198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243973 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 243973 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 243973 0
Australia
Date submitted for ethics approval [1] 243973 0
Approval date [1] 243973 0
18/08/2009
Ethics approval number [1] 243973 0

Summary
Brief summary
Background: Studies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone.
Methods: A 2-arm parallel pragmatic randomised controlled trial (+CBT – standard care plus either face-to-face (F2F) or online over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline.
Results: Participants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p>0.05). When only participants classified as ‘in need’ (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n=74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p=.034, d=.56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p=.045).
Conclusions: Future studies should direct psychological interventions to patients ‘in need’ and attempt to recruit larger samples to compensate for significant attrition when using online CBT.
Trial website
Trial related presentations / publications
1. Mikocka-Walus, A., Andrews, J., Bampton, P., Hughes, P., Esterman, A. (2016, March). Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: A randomised controlled trial with a 24-month follow-up, the European Crohn’s and Colitis Organisation Annual Congress, Amsterdam, the Netherlands;

2. Mikocka-Walus, A., Andrews, J., Bampton, P., Hughes, P., Esterman, A. (2015). Cognitive-behavioural therapy (CBT) improves QoL in IBD patients in need despite no global benefit on disease activity: 12 month data from a randomised controlled trial, BMC Gastroenterology, 2;15(1):54

3. Mikocka- Mikocka-Walus A, Hughes PA, Moretta M, Pilichiewicz AN, Long H, Hetzel D, Bampton PA, Andrews JM. (2014, February). Cognitive-behavioural therapy improves inflammatory responsiveness but not mental health short term in IBD patients: A pilot randomised controlled trial, European Crohn’s and Colitis Organisation Annual Congress, Copenhagen, Denmark;

4. Mikocka-Walus, A., Andrews, J.M. (2014, July). Cognitive-behavioural therapy to manage disease activity in inflammatory bowel disease: 6-month outcomes of the randomised controlled trial, 28th International Congress of Applied Psychology, Paris, France;

5. Mikocka-Walus, A. (2013, September). Cognitive-behavioural therapy in inflammatory bowel disease: What’s the evidence? 22nd World Congress on Psychosomatic Medicine, Lisbon, Portugal;

6. Mikocka-Walus, A., Bampton, P., Hetzel, D., Andrews, J. (2012, May), Cognitive-behavioural therapy changes the “in-vironment”, FALK Symposium on inflammatory bowel disease 2012, Basel, Switzerland;

7. Mikocka-Walus, A. (2011, June). CBT to manage IBD: Preliminary findings from an RCT, MSD Raising Expectations in Gastroenterology 2011, Sydney, Australia;

8. Mikocka-Walus, A., Bond, M., Holloway, R., Persson, J., Pilichiewicz, A.N., Hughes, P., Burke, A., Collins, K., Blackshaw, L.A., Holtmann, G., Andrews, JM. (2011, February). Cognitive behavioural therapy (CBT) to manage inflammatory bowel disease (IBD): preliminary findings, European Crohn’s and Colitis Organisation Annual Meeting, Dublin, Ireland;

9. Mikocka-Walus, A., Bond, M., Holloway, R., Persson, J., Pilichiewicz, A.N., Hughes, P., Burke, A., Collins, K., Blackshaw, L.A., Holtmann, G., Andrews, JM. (2010, May). Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? Initial feasibility report on a pilot randomised controlled trial. The Digestive Disease Week 2010, New Orleans, LA, the USA;

10. Mikocka-Walus, A., Bond, M., Holloway, R., Persson, J., Pilichiewicz, A.N., Hughes, P., Burke, A., Collins, K., Blackshaw, L.A., Holtmann, G., Andrews, JM. (2010, February). Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? Initial feasibility report on a pilot randomised controlled trial. European Crohn’s and Colitis Organisation Annual Meeting, Prague, Czech Republic;

11. Mikocka-Walus, A., Bond, M., Holloway, R., Persson, J., Pilichiewicz, A., Hughes, P., Burke, A., Collins, K., Blackshaw, L.A., Holtmann, G., Andrews, J. (2010, October). Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? Initial feasibility report on a pilot randomized controlled trial. The Australian Gastroenterology Week 2010, Gold Coast, Australia;
Public notes

Contacts
Principal investigator
Name 30364 0
Dr Antonina Mikocka-Walus
Address 30364 0
University of York
Department of Health Sciences
Heslington
York YO10 5DD
United Kingdom
Country 30364 0
United Kingdom
Phone 30364 0
+441904321521
Fax 30364 0
Email 30364 0
antonina.mikocka-walus@york.ac.uk
Contact person for public queries
Name 13611 0
A/Prof Jane Andrews
Address 13611 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 13611 0
Australia
Phone 13611 0
+61 8 8222 5207
Fax 13611 0
Email 13611 0
Jane.Andrews@health.sa.gov.au
Contact person for scientific queries
Name 4539 0
Dr Dr Antonina Mikocka-Walus
Address 4539 0
University of York
Department of Health Sciences
Heslington
York YO10 5DD
United Kingdom
Country 4539 0
United Kingdom
Phone 4539 0
+441904321521
Fax 4539 0
Email 4539 0
antonina.mikocka-walus@york.ac.uk

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