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Trial registered on ANZCTR
Registration number
ACTRN12615001020572
Ethics application status
Approved
Date submitted
24/09/2015
Date registered
30/09/2015
Date last updated
11/08/2021
Date data sharing statement initially provided
11/08/2021
Date results provided
11/08/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Examining the feasibility of an internet-delivered Cognitive Behaviour Therapy (iCBT) program for emotional wellbeing among people with functional gastrointestinal disorders
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Scientific title
Examining the feasibility of an internet-delivered Cognitive Behaviour Therapy (iCBT) program for emotional wellbeing among people with functional gastrointestinal disorders
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Secondary ID [1]
287542
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Functional gastrointestinal disorders
296309
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depression
296310
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anxiety
296311
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Condition category
Condition code
Oral and Gastrointestinal
296586
296586
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Mental Health
296587
296587
0
0
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Depression
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Mental Health
296588
296588
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is a low-intensity internet-delivered cognitive behavioural therapy (iCBT) program, the Chronic Conditions Course, which aims to help people to manage anxiety and depression and the impacts of functional gastrointestinal disorders.
The Course consists of:
(a) 5 online lessons provided over 8 weeks.
(b) A homework summary with assignments for each lesson
(c) Additional written resources that can be downloaded and which include information about other important skills, such as assertiveness and communication skills and techniques for managing sleep difficulties.
(d) Case Stories based on previous participants, which they can follow throughout the Course.
(e) Brief weekly contact with a Psychologist via secure email or telephone.
Participants will be encouraged to complete a lesson every 10 days and to read through a summary of the lesson and complete some basic homework in the following 10 days. Participants will have the option of being contacted by a Psychologist by phone or email each week for support with working through the course; each eCentreClinic Psychologist receives 1 hour or more of weekly supervision from another eCentreClinic Psychologist in which all of their participants are reviewed; as per best-practice guidelines and eCentreClinic Policy.
The Chronic Conditions Course is based on cognitive behaviour therapy (CBT) principles and teaches evidence-based skills for managing disability, anxiety and depression associated with chronic health conditions. Each lesson takes between 10 and 20 minutes to complete and it is suggested that participants read each lesson at least twice and spend approximately 3 hours, across the week, practicing the skills taught. Telephone calls will be limited to approximately 10 minutes per week; however, more time will be provided where clinically indicated. Adherence (e.g., logins, lesson completion, lesson views, time spent on course) will be monitored via the eCentreClinic software, which is used to provide the Chronic Conditions Course.
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Intervention code [1]
292940
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Behaviour
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Comparator / control treatment
This is a single-group pilot study. No comparator condition is present.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Gastrointestinal Symptom Rating Scale (GSRS), a measure of gastrointestinal symptom severity.
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Assessment method [1]
296199
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Timepoint [1]
296199
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Application, Pre-treatment, post-treatment, 3-months post-treatment.
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Primary outcome [2]
296200
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Patient Health Questionnaire - 9 item (PHQ-9), a measure of depressive symptoms.
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Assessment method [2]
296200
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Timepoint [2]
296200
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Application, Pre-treatment, post-treatment, 3-months post-treatment.
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Primary outcome [3]
296201
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Generalized Anxiety Disorder - 7 item (GAD-7), a measure of general anxiety symptoms
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Assessment method [3]
296201
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Timepoint [3]
296201
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Application, Pre-treatment, post-treatment, 3-months post-treatment.
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Secondary outcome [1]
317797
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Pain Catastrophising Scale (PCS), a measure of pain catastrophising.
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Assessment method [1]
317797
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Timepoint [1]
317797
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Pre-treatment, post-treatment, 3-months post treatment.
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Secondary outcome [2]
317798
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Treatment Satisfaction Questionnaire. A measure assessing the acceptability and satisfaction with the treatment course.
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Assessment method [2]
317798
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Timepoint [2]
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Post-treatment
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Secondary outcome [3]
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Service Use Questionnaire, a measure of health service utilisation by the participant.
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Assessment method [3]
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Timepoint [3]
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Pre-treatment, post-treatment, 3-months post treatment.
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Eligibility
Key inclusion criteria
(a) Diagnosed with a functional gastrointestinal disorder (FGID)
(b) Experienced FGID symptoms for longer than 6 months
(c) Self-reports experiencing anxiety and depression or wanting to learn to manage emotional wellbeing
(d) Has had a recent consultation (i.e., in the last 6 months) with a GP or specialist
(e) Is living in Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(a) Severe depression (i.e., indicated by a score > 22 on the PHQ-9)
(b) Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
(c) Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
(d) Have been diagnosed with an irritable bowel disease (such as Chron’s disease, ulcerative colitis) or any gastrointestinal cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2015
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Actual
1/09/2015
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Date of last participant enrolment
Anticipated
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Actual
31/10/2015
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Date of last data collection
Anticipated
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Actual
31/03/2016
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Sample size
Target
30
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
292105
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
292105
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Primary sponsor type
University
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Name
eCentreClinic, Department of Psychology, Macquarie University
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Address
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
290782
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Address [1]
290782
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Country [1]
290782
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
293593
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Macquarie University, Human Research Ethics Committee
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Ethics committee address [1]
293593
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Human Research Ethics Committee Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.
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Ethics committee country [1]
293593
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Australia
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Date submitted for ethics approval [1]
293593
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Approval date [1]
293593
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12/09/2014
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Ethics approval number [1]
293593
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5201400751
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Summary
Brief summary
The purpose of the proposed project is to conduct a pilot study of the acceptability, efficacy and feasibility of a low-intensity internet-delivered CBT (iCBT) self-management program, the Chronic Conditions Course, in reducing symptoms of anxiety and depression adults with functional gastrointestinal disorders. The proposed trial employs a single-group open-trial design (n = 30) and participants will be given access to an internet-delivered CBT Course; a 5-lesson 8 week self-management program. Participants will have brief weekly contact with a Clinical Psychologist as they work through the Course.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Blake Dear
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Address
60594
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eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
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Country
60594
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Australia
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Phone
60594
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61 2 9850 9979
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Fax
60594
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Email
60594
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[email protected]
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Contact person for public queries
Name
60595
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Blake Dear
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Address
60595
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eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
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Country
60595
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Australia
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Phone
60595
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61 2 9850 9979
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Fax
60595
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Email
60595
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[email protected]
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Contact person for scientific queries
Name
60596
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Blake Dear
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Address
60596
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eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
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Country
60596
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Australia
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Phone
60596
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61 2 9850 9979
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Fax
60596
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Email
60596
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
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When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
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Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
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Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
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How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator (
[email protected]
)
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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.
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