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Trial registered on ANZCTR


Registration number
ACTRN12617001133325
Ethics application status
Approved
Date submitted
31/07/2017
Date registered
2/08/2017
Date last updated
5/12/2022
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an internationally-available, self-guided, online pain management program for adults
Scientific title
The Pain Course: Exploring the efficacy of an international self-guided online pain management program for adults with chronic pain.
Secondary ID [1] 292542 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 304195 0
Depression 304196 0
Anxiety 304197 0
Condition category
Condition code
Anaesthesiology 303531 303531 0 0
Pain management
Mental Health 303532 303532 0 0
Depression
Mental Health 303533 303533 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomised controlled trial, all participants will receive access to an 8 week internet-delivered, self-guided education course, the Pain Course, which teaches participants how to manage chronic pain, anxiety, and low mood. All participants will have experienced chronic pain for longer than 6 months.
The Pain Course comprises 5 online lessons, which provide information about evidence-based, cognitive behavioural strategies for managing pain, anxiety and depression. One lesson will be completed every 7 to 10 days. Each lesson will take about 20 minutes to read. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with chronic pain, depression, and anxiety, taking a further 20 minutes per week.
All participants will receive automatic emails to promote adherence and engagement. Specifically, participants will receive an automatic email: a) from the Clinic Director in the first week of the course to thank them for their participation; b) each time a new lesson becomes available; c) when they complete a lesson; d) if they have not started a given lesson within 7 days (i.e. a reminder email); e) in Week 4, to inform them that slight increases in symptoms at that point are not uncommon; f) in week 7 to encourage them to complete any remaining lessons by the end of week 8; g) in week 8 to remind them it is the last week and of the post-treatment questionnaires. As the receipt of some of these emails is contingent upon a participant’s activity (e.g. not completing a course within 7 days), the exact number of emails received will vary between participant. However, each will receive between 10 and 20 automatic emails over the duration of the course.
Participants in this research trial will be randomly allocated to an Active Treatment Group or a Waitlist Control Group. Participants in the Active Treatment Group will receive full access to the Pain Course. The Waitlist Control Group will receive the same treatment after the Active Treatment Group has completed the 8-week Course. Participants will be asked to complete standardised questionnaire measures at 4 main time points: Initial application, pre-treatment, mid-treatment, and post-treatment. Participants will also complete brief standardised questionnaire measures of anxiety and depression weekly throughout the Course.
The strategy used to monitor adherence to the intervention will be online monitoring of lessons completed (i.e., completion is logged online once the participant clicks through all the slides of the lesson).
Intervention code [1] 298737 0
Treatment: Other
Intervention code [2] 298738 0
Behaviour
Comparator / control treatment
Participants in this research trial will be randomly allocated to an Active Treatment Group or a Waitlist Control Group. The Waitlist Control Group will receive the treatment after the Active Treatment Group has completed the 8-week Course.
Control group
Active

Outcomes
Primary outcome [1] 302901 0
Symptoms and severity of depression will be measured by the two-item Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 302901 0
Administered at initial application, pre-treatment, mid-treatment and post-treatment.
Primary outcome [2] 302902 0
Symptoms and severity of general anxiety will be measured by the two-item Generalized Anxiety Disorder Scale-7 (GAD-7).
Timepoint [2] 302902 0
Administered at initial application, pre-treatment, mid-treatment and post-treatment.
Primary outcome [3] 302941 0
The interference of pain on participants' life will be measured by the Pain Interference Scale (PIQ), a 7-item measure.
Timepoint [3] 302941 0
Administered at initial application, pre-treatment, mid-treatment and post-treatment.
Secondary outcome [1] 337384 0
The nature of participants’ pain, including its location, its severity and responsiveness to pain medications, will be measured by the Wisconsin Brief Pain Questionnaire (WBPQ), a 4-item composite secondary outcome.
Timepoint [1] 337384 0
Administered at initial application, pre-treatment, mid-treatment and post-treatment.
Secondary outcome [2] 337394 0
PROMIS 10 will be used as a measure of overall health.
Timepoint [2] 337394 0
Administered at initial application, pre-treatment, mid-treatment and post-treatment.
Secondary outcome [3] 337396 0
The acceptability and participant satisfaction with the Pain Course will be measured at post-treatment by the Treatment Satisfaction Questionnaire (TSQ), a 10-item measure developed by the research team conducting the present research.
Timepoint [3] 337396 0
TSQ: Post-treatment
Secondary outcome [4] 370356 0
Big Five Inventory 10-item.
Timepoint [4] 370356 0
Pre-treatment and post-treatment
Secondary outcome [5] 370357 0
Short Flourishing Scale (SFS)
Timepoint [5] 370357 0
Pre-treatment and post-treatment
Secondary outcome [6] 370358 0
De John Gierveld Loneliness Scale (DLS) 6-item
Timepoint [6] 370358 0
Pre-treatment and post-treatment
Secondary outcome [7] 370359 0
Brief Illness Perception Questionnaire (BIPQ).
Timepoint [7] 370359 0
Pre-treatment and post-treatment Importantly, these changes were made before any participants were enrolled in the research trial.

Eligibility
Key inclusion criteria
1. Have experienced chronic pain for longer than 6 months
2. Have had their pain assessed and managed by a GP or specialist to rule out malignant or treatable causes
3. Are aged 18 or older
4. Are living outside of Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant suicidal ideation (indicated by a score >2 to Question 9 of the PHQ-9)
2. Self-reported risk of suicide
3. Unable to read and understand English

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)
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. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
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
With alpha set at 0.05, power set at 0.80 and a sample size of 120, the study is powered to enable the detection of moderate-to-large effect size (i.e., Cohen’s d > 0.40) differences in symptoms of pain, anxiety, depression and disability at each time point. However, more participants are being recruited to enable exploratory analyses to examine the prediction and moderation of clinical response in subgroups of participants (e.g., patients with specific pain conditions, such as complex regional pain syndrome).

Subgroup analyses be utilised to assess change in the clinical outcomes from baseline to post-treatment for certain, of interest, subgroups. For example, sub-group analyses will assess treatment effects for participants with baseline levels of anxiety, depression and disability within the clinical ranges separately from the overall sample. Clinical levels of baseline symptoms will be based on the published literature e.g., depression (PHQ-9>9), anxiety (GAD-7 >9) and disability levels (PIQ within the 25th, 50th and 75th percentiles). All analyses will be carried out using conservative intention-to-treat principles and using generalised equation (GEE) models to handle missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
17/06/2019
Date of last participant enrolment
Anticipated
27/11/2023
Actual
Date of last data collection
Anticipated
18/03/2024
Actual
Sample size
Target
1000
Accrual to date
543
Final
Recruitment outside Australia
Country [1] 9103 0
New Zealand
State/province [1] 9103 0
Country [2] 9104 0
United States of America
State/province [2] 9104 0
Country [3] 9105 0
United Kingdom
State/province [3] 9105 0
Country [4] 9106 0
Canada
State/province [4] 9106 0
Country [5] 9107 0
Ireland
State/province [5] 9107 0
Country [6] 9108 0
South Africa
State/province [6] 9108 0

Funding & Sponsors
Funding source category [1] 297114 0
University
Name [1] 297114 0
Macquarie University
Country [1] 297114 0
Australia
Primary sponsor type
University
Name
Department of Psychology, Macquarie University
Address
Department of Psychology
Building C3A
Balaclava Road, North Ryde
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 296127 0
None
Name [1] 296127 0
Address [1] 296127 0
Country [1] 296127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298292 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 298292 0
Macquarie University
Balaclava Road, North Ryde
NSW 2109
Ethics committee country [1] 298292 0
Australia
Date submitted for ethics approval [1] 298292 0
Approval date [1] 298292 0
01/05/2019
Ethics approval number [1] 298292 0
5201700388

Summary
Brief summary
The primary purpose of this project is to explore the efficacy of the Pain Course in an entirely self-guided format, for managing symptoms of pain interference, anxiety, and depression in adults (aged 18+) living outside Australia with chronic pain.
A second purpose is to examine the acceptability of the Pain Course in a self-guided format to adults living outside of Australia with chronic pain.
A third purpose is to explore predictors of treatment response to the Pain Course in a self-guided format to adults living outside of Australia with chronic pain.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76610 0
Dr Blake Dear
Address 76610 0
Department of Psychology
Macquarie University
North Ryde NSW
2109
Country 76610 0
Australia
Phone 76610 0
+61 2 9850 9979
Fax 76610 0
Email 76610 0
[email protected]
Contact person for public queries
Name 76611 0
Vincent Fogliati
Address 76611 0
Department of Psychology
Macquarie University
North Ryde NSW
2109
Country 76611 0
Australia
Phone 76611 0
+61 2 9850 9656
Fax 76611 0
Email 76611 0
[email protected]
Contact person for scientific queries
Name 76612 0
Vincent Fogliati
Address 76612 0
Department of Psychology
Macquarie University
North Ryde NSW
2109
Country 76612 0
Australia
Phone 76612 0
+61 2 9850 9656
Fax 76612 0
Email 76612 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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14544Study protocol  [email protected]
14545Informed consent form  [email protected]
14546Ethical approval  [email protected]
14547Analytic code  [email protected]
14548Statistical analysis plan  [email protected]



Results publications and other study-related documents

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