Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001329358
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
18/09/2017
Date last updated
9/02/2024
Date data sharing statement initially provided
9/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Effectiveness of the Pain Course in a Regional Hospital Pain Clinic Setting
Scientific title
Examining the effectiveness of the Pain Course, an internet delivered program for pain management, on symptoms of depression, anxiety and disability, in a regional hospital pain clinic setting.
Secondary ID [1] 292837 0
nil known
Universal Trial Number (UTN)
U1111-1201-8092
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 304677 0
Depression 304708 0
Anxiety 304709 0
Condition category
Condition code
Anaesthesiology 304015 304015 0 0
Pain management
Mental Health 304016 304016 0 0
Depression
Mental Health 304017 304017 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this single group 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 study coordinator 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 are all those referred for clinical care to the North Queensland Persistent Pain Management Service. Participants will be asked to complete standardised questionnaire measures at 3 main time points: pre-treatment, post-treatment and 3-month follow up. Participants will also complete brief standardised questionnaire measures of depression weekly throughout the Course. To enable the researchers to monitor symptoms and safety throughout the Course, participants will also complete a single-item, question 9 from the PHQ-9, which measures suicidal ideation. This item will be measured at initial application, pre-treatment, mid-treatment, post-treatment and 3-month follow up, and weekly throughout the course. However, this item will not be used for reporting purposes, and has not been included in the list of Outcomes in Step 4.
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] 299106 0
Treatment: Other
Intervention code [2] 299107 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303348 0
Symptoms and severity of depression will be measured by the nine-item Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 303348 0
Administered at pre-treatment, weekly throughout the course, post-treatment, and 3-month follow-up
Primary outcome [2] 303349 0
Symptoms and severity of general anxiety will be measured by the seven-item Generalized Anxiety Disorder Scale-7 (GAD-7)
Timepoint [2] 303349 0
Administered at pre-treatment, post-treatment, and 3-month follow-up.
Primary outcome [3] 303352 0
Level of disability will be measured by the Roland Morris Disability Questionnaire (RMDQ), a 24 item measure.
Timepoint [3] 303352 0
Administered at pre-treatment, post-treatment, and 3-month follow-up.
Secondary outcome [1] 338716 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] 338716 0
Administered at pre-treatment, post-treatment, and 3-month follow-up.
Secondary outcome [2] 338717 0
Pain related self-efficacy beliefs will be assessed with the Patient Self Efficacy Questionnaire (PSEQ), a 10 item measure.
Timepoint [2] 338717 0
Administered at pre-treatment, post treatment and 3 month follow-up.
Secondary outcome [3] 338718 0
Treatment satisfaction and acceptability will be assessed by five questions previously utilised in examining the acceptability of other internet delivered treatments and other trials of The Pain Course: 1. 'Overall, how satisfied were you with the Course?' 2. 'How satisfied were you with the quality of the materials?' 3 'Would you feel confident in recommending this Course to a friend?' 4. 'Was it worth your time doing the course?' 5. 'How has participating in this course affected your confidence that you can learn to manage symptoms of pain, anxiety and low mood?'
Timepoint [3] 338718 0
Administered at post treatment only.

Eligibility
Key inclusion criteria
a) Have experienced chronic pain longer than 6months
b) Has had a recent consultation (i.e. in the last 6 months) with a GP or specialist; and is not highly dependent on medical care
c) Is living in Australia
d) Are 18years or older
e) Is a patient of the North Queensland Persistent Pain Management Service
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) Persons without access to a computer and internet.

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)
N/A
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
With an alpha at 0.05 and power set at 80%, 90 participants are needed to detect an effect size of 0.30 any specific outcome. However, to hedge against attrition and to comprehensively explore the acceptability of the Pain Course, 100 participants will be recruited to examine change over time on the primary outcomes. However, based on initial results and if resources are available, more participants will be recruited with the approval of the hospital HREC. This will enable the research team to conduct preliminary subgroup analyses to explore the efficacy of the Pain Course for particular subgroups of participants. Importantly, subgroup analyses are important in the area of chronic pain where the patient population is very heterogeneous with different clinical outcomes not being relevant to all participants (e.g., not all participants are depression or anxious or disabled) and patients presenting with a broad range of pain conditions. Mixed linear models analyses will be conducted to examine clinical changes from pre-treatment to post-treatment and follow-up. Effect size will be calculated using Cohen’s d with pooled standard deviations.

The primary efficacy analyses will be carried out using conservative intention-to-treat principles and using generalised estimating equation (GEE) modelling. GEE models are a robust statistical approach for analysing clinical trial data and these analyses will employ an appropriate covariance structure and maximum likelihood estimation, which provides unbiased estimates in the case of missing data; under the assumption that data is missing at random.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2017
Actual
11/10/2017
Date of last participant enrolment
Anticipated
28/02/2019
Actual
2/10/2023
Date of last data collection
Anticipated
31/07/2019
Actual
22/01/2024
Sample size
Target
600
Accrual to date
Final
653
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8989 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 17488 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 297468 0
Hospital
Name [1] 297468 0
The Townsville Hospital
Country [1] 297468 0
New Zealand
Funding source category [2] 297494 0
Government body
Name [2] 297494 0
Department of Health Queensland
Country [2] 297494 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive, Douglas, QLD 4814
Country
Australia
Secondary sponsor category [1] 296466 0
None
Name [1] 296466 0
Address [1] 296466 0
Country [1] 296466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298573 0
Townsville Hospital and Health Service Human Researcg Ethics Committee
Ethics committee address [1] 298573 0
Ethics committee country [1] 298573 0
Australia
Date submitted for ethics approval [1] 298573 0
Approval date [1] 298573 0
09/02/2017
Ethics approval number [1] 298573 0
16/QTHS/248_3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77518 0
Mrs Shereen Gilmore
Address 77518 0
North Queensland Persistent Pain Management Service,
The Townsville Hospital and Health Service,
100 Angus Smith Drive, Douglas, QLD 4814
Country 77518 0
Australia
Phone 77518 0
+61744335300
Fax 77518 0
+61744335301
Email 77518 0
[email protected]
Contact person for public queries
Name 77519 0
Shereen Gilmore
Address 77519 0
North Queensland Persistent Pain Management Service,
The Townsville Hospital and Health Service,
100 Angus Smith Drive, Douglas, QLD 4814
Country 77519 0
Australia
Phone 77519 0
+61744335300
Fax 77519 0
+61744335301
Email 77519 0
[email protected]
Contact person for scientific queries
Name 77520 0
Blake Dear
Address 77520 0
Department of Psychology
Macquarie University
North Ryde NSW
2109
Country 77520 0
Australia
Phone 77520 0
+61 2 9850 9979
Fax 77520 0
+61 2 9850 9970
Email 77520 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?
De-identified aggregate data.
When will data be available (start and end dates)?
All data will be available from trial commencement to completion.
Available to whom?
Researchers with recognised HREC approval and subject to an approved data sharing agreement.
Available for what types of analyses?
Any analyses required for validation purposes.
How or where can data be obtained?
Through contact with the North Queensland Persistent Pain Management Service or Professor Blake Dear via email ([email protected])


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.