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Trial registered on ANZCTR


Registration number
ACTRN12614000768695
Ethics application status
Approved
Date submitted
9/07/2014
Date registered
18/07/2014
Date last updated
14/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pain Course: Examining a low-intensity Cognitive Behaviour Therapy (CBT) program for chronic pain when administered via the internet versus workbook
Scientific title
The Pain Course: Examining a low-intensity Cognitive Behaviour Therapy (CBT) program for chronic pain when administered via the internet versus workbook.
Secondary ID [1] 284956 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 292442 0
Anxiety
292443 0
Depression 292444 0
Condition category
Condition code
Anaesthesiology 292756 292756 0 0
Pain management
Mental Health 292757 292757 0 0
Anxiety
Mental Health 292758 292758 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: (1) a group who receive the Pain Course via the internet, and (2) a group who receive the Pain Course via a hardcopy workbook. All participants will meet diagnostic criteria for chronic pain (i.e. pain lasting longer than 6 months). All participants will complete 5 lessons of the Pain Course, which provide information about the management of symptoms of chronic pain and anxiety, depression and disability associated with pain. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with chronic pain, taking a further 20 minutes per summary.

Participants in both groups will have the option of weekly telephone calls or emails from a trained and supervised Psychologist at the eCentreClinic to provide support, encouragement and to answer questions about the content of the Course. The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 3 and 12 month follow-up. Some questionnaires will be administered weekly during the Course. The major sets of questionnaires will take about 10 to 15 minutes to complete. The treatment materials are based on previous internet-based programs, which apply cognitive behavioural techniques.
Intervention code [1] 289783 0
Behaviour
Comparator / control treatment
The internet-based version of the Pain Course will be employed as an active comparator.
Control group
Active

Outcomes
Primary outcome [1] 292602 0
Roland Morris Disability Questionnaire (RMDQ) and Pain Disability Index (PDI), which are two measures of disability.
Timepoint [1] 292602 0
Application, pre-treatment, mid-treatment, post-treatment and 3 and 12 month follow-up
Primary outcome [2] 292603 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 292603 0
Application, pre-treatment, mid-treatment, post-treatment and 3 and 12 month follow-up
Primary outcome [3] 292604 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 292604 0
Application, pre-treatment, mid-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [1] 309316 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 309316 0
Application, pre-treatment, mid-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [2] 309317 0
Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
Timepoint [2] 309317 0
Pre-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [3] 309318 0
Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.
Timepoint [3] 309318 0
Pre-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [4] 309319 0
The Pain Catastrophising Scale (PCS), which is a widely used measure of cognitive set.
Timepoint [4] 309319 0
Pre-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [5] 309320 0
Chronic Pain Acceptance Questionnaire 8-item (CPAQ8), which measures acceptance of chronic pain.
Timepoint [5] 309320 0
Pre-treatment, post-treatment and 3 and 12 month follow-up
Secondary outcome [6] 309321 0
Employment and health service use will be measured by the Employment and Health Service Use Questionnaire
Timepoint [6] 309321 0
Pre-treatment, post-treatment and 3 and 12 month follow-up

Eligibility
Key inclusion criteria
- Has experienced Chronic Pain (i.e. Pain > 6 months)
- Internet access + Printer access
- Australian resident
- Has had their pain assessed by their GP or medical specialist.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active psychosis
- Pain not assessed by GP
- Severe depression, suicidal intent or plan (PHQ-9 total score > 22; PHQ-9 Question 9 score > 2)
- Actively suicidal or recent history of attempted suicide or self-harm

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
All analyses will be carried out using conservative intention-to-treat principles and using mixed-linear models analyses to handle missing data. Mixed-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.

Sample size: With alpha set at 0.05, power set at 0.80 and a sample size of 160, the study is powered to enable the detection of small-to-large between group effect size (i.e., > 0.40) differences in symptoms of anxiety, depression and disability. Thus, the project is powered to detect differences between the groups in symptoms likely to be clinically meaningful.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289576 0
Government body
Name [1] 289576 0
Motor Accidents Authority of New South Wales
Address [1] 289576 0
Motor Accidents Authority of NSW
Address: Motor Accidents Authority
Level 25, 580 George Street
Sydney NSW 2000, Australia
DX: DX 1517 SYDNEY
Country [1] 289576 0
Australia
Primary sponsor type
Individual
Name
Dr Blake Dear
Address
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 288260 0
University
Name [1] 288260 0
Macquarie University
Address [1] 288260 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, North Ryde, NSW, 2109, Australia.
Country [1] 288260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291313 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 291313 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, North Ryde, NSW, 2109.
Ethics committee country [1] 291313 0
Australia
Date submitted for ethics approval [1] 291313 0
Approval date [1] 291313 0
30/06/2014
Ethics approval number [1] 291313 0
5201400592

Summary
Brief summary
The current research project aims to investigate the efficacy and acceptability of the Pain Course when delivered via a hardcopy workbook (wCBT) versus in a softcopy format via the internet (iCBT). Importantly, given that many Australians still do not have reliable access to the internet, if efficacious and acceptable, workbook delivery represents another simple, low cost, approach for increasing access to evidence-based treatment for people with chronic pain.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49830 0
Dr Blake Dear
Address 49830 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49830 0
Australia
Phone 49830 0
+61 2 9850 9979
Fax 49830 0
Email 49830 0
blake.dear@mq.edu.au
Contact person for public queries
Name 49831 0
Dr Blake Dear
Address 49831 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49831 0
Australia
Phone 49831 0
+61 2 9850 9979
Fax 49831 0
Email 49831 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 49832 0
Dr Blake Dear
Address 49832 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49832 0
Australia
Phone 49832 0
+61 2 9850 9979
Fax 49832 0
Email 49832 0
blake.dear@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary