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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 information initially 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
Scientific title
Examining the feasibility of an internet-delivered Cognitive Behaviour Therapy (iCBT) program for emotional wellbeing among people with functional gastrointestinal disorders
Secondary ID [1] 287542 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional gastrointestinal disorders 296309 0
depression 296310 0
anxiety 296311 0
Condition category
Condition code
Oral and Gastrointestinal 296586 296586 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 296587 296587 0 0
Depression
Mental Health 296588 296588 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 292940 0
Behaviour
Comparator / control treatment
This is a single-group pilot study. No comparator condition is present.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296199 0
Gastrointestinal Symptom Rating Scale (GSRS), a measure of gastrointestinal symptom severity.
Timepoint [1] 296199 0
Application, Pre-treatment, post-treatment, 3-months post-treatment.
Primary outcome [2] 296200 0
Patient Health Questionnaire - 9 item (PHQ-9), a measure of depressive symptoms.
Timepoint [2] 296200 0
Application, Pre-treatment, post-treatment, 3-months post-treatment.
Primary outcome [3] 296201 0
Generalized Anxiety Disorder - 7 item (GAD-7), a measure of general anxiety symptoms
Timepoint [3] 296201 0
Application, Pre-treatment, post-treatment, 3-months post-treatment.
Secondary outcome [1] 317797 0
Pain Catastrophising Scale (PCS), a measure of pain catastrophising.
Timepoint [1] 317797 0
Pre-treatment, post-treatment, 3-months post treatment.
Secondary outcome [2] 317798 0
Treatment Satisfaction Questionnaire. A measure assessing the acceptability and satisfaction with the treatment course.
Timepoint [2] 317798 0
Post-treatment
Secondary outcome [3] 317799 0
Service Use Questionnaire, a measure of health service utilisation by the participant.
Timepoint [3] 317799 0
Pre-treatment, post-treatment, 3-months post treatment.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
31/10/2015
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292105 0
Self funded/Unfunded
Name [1] 292105 0
Country [1] 292105 0
Primary sponsor type
University
Name
eCentreClinic, Department of Psychology, Macquarie University
Address
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 290782 0
None
Name [1] 290782 0
Address [1] 290782 0
Country [1] 290782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293593 0
Macquarie University, Human Research Ethics Committee
Ethics committee address [1] 293593 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.
Ethics committee country [1] 293593 0
Australia
Date submitted for ethics approval [1] 293593 0
Approval date [1] 293593 0
12/09/2014
Ethics approval number [1] 293593 0
5201400751

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60594 0
Dr Blake Dear
Address 60594 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60594 0
Australia
Phone 60594 0
61 2 9850 9979
Fax 60594 0
Email 60594 0
[email protected]
Contact person for public queries
Name 60595 0
Blake Dear
Address 60595 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60595 0
Australia
Phone 60595 0
61 2 9850 9979
Fax 60595 0
Email 60595 0
[email protected]
Contact person for scientific queries
Name 60596 0
Blake Dear
Address 60596 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60596 0
Australia
Phone 60596 0
61 2 9850 9979
Fax 60596 0
Email 60596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
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])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Dear, B. F., Fogliati, V. J., Fogliati, R., Gandy,... [More Details]

Documents added automatically
No additional documents have been identified.