Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000820808
Ethics application status
Approved
Date submitted
17/07/2012
Date registered
6/08/2012
Date last updated
6/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
IBDclinic: A validation trial of the world’s first evidence-based, automated, online program for the assessment and treatment of inflammatory bowel disease (IBD)-associated anxiety and depression.
Scientific title
In adults with Inflammatory bowel disease and associated anxiety and depression, will participation in an online psychological treatment program, as opposed to receiving treatment as usual, reduce symptoms of anxiety and depression
Secondary ID [1] 280859 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 286928 0
Depression 286929 0
Anxiety 286930 0
Condition category
Condition code
Oral and Gastrointestinal 287258 287258 0 0
Inflammatory bowel disease
Mental Health 287259 287259 0 0
Depression
Mental Health 287260 287260 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aims of the project are to: (1) Develop and validate an online psychological treatment program specifically designed to diagnose and treat Panic Disorder (PD) and/or Major Depressive Episode (MDE), Social Anxiety Disorder (SAD), Generalised Anxiety Disorder (GAD) associated with IBD; and, (2) Make this specialized service available free of charge to all individuals with IBD throughout Australia and internationally.

The treatment program, a CBT based support program, address several key issues identified in the literature and in the IBD clinics, including; psychoeducation about IBD, nutrition and IBD, mindfulness and relaxation strategies, managing pain, dealing with worry and unhelpful thoughts, and identifying and establishing adaptive cognitive coping strategies.

Participants, over 14 weeks (completing one module per week in their own time [max 2 hours/module]) complete the assessment and treatment modules they will also be asked to provide feedback and suggestions regarding the IBDclinic content in weekly questionnaires (mailed back at the end of the intervention).
Intervention code [1] 285287 0
Lifestyle
Intervention code [2] 285408 0
Behaviour
Comparator / control treatment
Treatment as usual (TAU)

Participants allocated to the TAU groups (TAU-MDE, TAU-PD, TAU-GAD, TAU-SAD) will have access to the standard referral services, such as GPs, psychologist, counsellors, medication, etc). In addition they will have limited access to IBDclinic so that they can complete the ePASS assessments. Participants allocated to the treatment groups (IBDclinic -MDE, IBDclinic-PD, IBDclinic -SAD, IBDclinic -GAD) will be given access to ePASS and the relevant treatment module. With the patient’s permission, gastroenterologists will provide the researchers a summary of the individual’s diagnosis, disease severity score (CDAI or UCDAI) and psychological condition.
Control group
Active

Outcomes
Primary outcome [1] 287538 0
Primary Outcome 1: Difference in rating on ePASS of anxiety or depression between the treatment as usual and IBDclinic intervention groups.

e-PASS is broken up into a series of modules and each module assesses for a particular mental health condition (e.g., Panic Disorder). Depending on how you answer the questions in each module, you will either be asked to continue to complete more questions or you will by-pass that particular module and jump to the next one that assesses for another mental health condition (e.g., Social Anxiety Disorder). This process continues until you reach the last module. Once completed e-PASS will automatically generate a feedback summary form that will provide you with the results of your online psychological assessment and treatment recommendations (if symptoms were identified).
Timepoint [1] 287538 0
at baseline and immediately post intervention (14 weeks on), + 3 months after cessation of the intervention
Secondary outcome [1] 298352 0
Nil
Timepoint [1] 298352 0
Nil

Eligibility
Key inclusion criteria
Individuals attending an IBD outpatient clinics in Melbourne will be recruited into this study. Additional inclusion criteria are: (a) age over 18 years and ability to provide written informed consent; (b) a primary diagnosis of Major Depressive Disorder (MDD), Panic Disorder (PD) Social Anxiety Disorder (SAD), Generalised Anxiety Disorder (GAD); not currently receiving psychological treatment for MDD, PD, SAD, GAD (c) if using steroidal medication, must have been maintained on a stable dose for at least three months and must maintain constant dose throughout the course of the study; and (d) access to internet-enabled computer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: a) severe depression (as determined by initial gastroenterologist review or by ePASS) and/or suicide risk requiring immediate treatment; (b) primary diagnosis of a DSM-IV disorder other than MDE, PD, SAD, or GAD; (c) current use of psychotropic medication (e.g., anti-depressant or anxiolytic); and (d) indeterminate IBD. People who do not meet criteria, yet require further assistance, will be referred back to their consulting gastroenterologist, GP, or relevant mental health service.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5547 0
3065
Recruitment postcode(s) [2] 5548 0
3052

Funding & Sponsors
Funding source category [1] 285644 0
Charities/Societies/Foundations
Name [1] 285644 0
The BROAD foundation
Country [1] 285644 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
The BROAD foundation
Address
The Broad Foundations
10900 Wilshire Boulevard
Twelfth Floor
Los Angeles, California 90024
Country
United States of America
Secondary sponsor category [1] 284479 0
None
Name [1] 284479 0
Address [1] 284479 0
Country [1] 284479 0
Other collaborator category [1] 276941 0
Hospital
Name [1] 276941 0
St Vincent's Hospital
Address [1] 276941 0
St Vincent's PO Box 2900, Fitzroy VIC 3065
Country [1] 276941 0
Australia
Other collaborator category [2] 276942 0
University
Name [2] 276942 0
Swinburne University of Technology
Address [2] 276942 0
Swinburne University
PO Box 218
HAWTHORN VIC 3122
Country [2] 276942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287643 0
The Human Research Ethics Committee-A (HREC-A) ? St Vincent?s Hospital Melbourne
Ethics committee address [1] 287643 0
PO BOX 2900
Fitzroy, Victoria
3065
Australia.
Ethics committee country [1] 287643 0
Australia
Date submitted for ethics approval [1] 287643 0
Approval date [1] 287643 0
14/06/2011
Ethics approval number [1] 287643 0
HREC-A 101/10

Summary
Brief summary
Patients will be recruited from outpatient clinics at Royal Melbourne Hospital (3052) and St Vincent’s Hospital (3065).

This research involves the development and evaluation of an online intervention designed to provide individually tailored interventions to treat Panic Disorder, Major Depression, Social Anxiety, and Generalised Anxiety associated with IBD. Research has shown that people with IBD have higher levels of Panic Disorder (PD) and Major Depression (MDE; Major Depressive Episode), Social Anxiety Disorder (SAD), and Generalised Anxiety Disorder (GAD) than people with other chronic health conditions. While research on the effectiveness of psychological interventions in IBD is encouraging to date only limited work has been done on the evaluation of these programs. The aims of the current research project are to: (1) Develop and validate an online psychological treatment program specifically designed to diagnose and treat PD GAD, SAD, and/or MDE symptoms associated with IBD, and (2) Make this specialized service available free of charge to all individuals with IBD throughout Australia and internationally.

In this project a three stage development and evaluation of an online intervention for IBD: (1) Development stage where an IBDeTherapy website is developed, revised and tested; (2) Evaluation stage I where 40 IBD patients complete a 14 week intervention program online; and, (3) Evaluation stage II involves 240 individuals from an IBD outpatient hospital cohort (Intervention groups: 30 MDE, 30 PD, 30 SAD, 30 GAD; Treatment as usual control groups: 30 MDE, 30 PD, 30 SAD, 30 GAD) in a large trial of the program that incorporates changes based on the initial evaluation stage. The present project is innovative because provision of online programs for IBD sufferers has the potential to provide better psychological care to these people than previously available. In addition, the established effectiveness of online intervention programs with clinical populations suggests that an online intervention is likely to have a high uptake and thus reduce the pressure on the health system.
Trial website
www.ibdclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34447 0
Address 34447 0
Country 34447 0
Phone 34447 0
Fax 34447 0
Email 34447 0
Contact person for public queries
Name 17694 0
Dr Simon Knowles
Address 17694 0
Swinburne University of Technology
PO Box 218 Hawthorn VIC Australia 3122
Office: ATC1042
Country 17694 0
Australia
Phone 17694 0
+61 3 9214 8206
Fax 17694 0
+61 3 9819 0574
Email 17694 0
[email protected]
Contact person for scientific queries
Name 8622 0
Dr Simon Knowles
Address 8622 0
Swinburne University of Technology
PO Box 218 Hawthorn VIC Australia 3122
Office: ATC1042
Country 8622 0
Australia
Phone 8622 0
+61 3 9214 8206
Fax 8622 0
+61 3 9819 0574
Email 8622 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

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No documents have been uploaded by study researchers.

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