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Trial registered on ANZCTR


Registration number
ACTRN12613000252718
Ethics application status
Approved
Date submitted
1/03/2013
Date registered
4/03/2013
Date last updated
18/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pain Course: A Randomised Controlled Trial assessing the efficacy and acceptability of an Internet Delivered-Treatment Program for Managing Chronic Pain provided with different levels of clinical support.
Scientific title
The Pain Course: A Randomised Controlled Trial assessing an Internet Delivered-Treatment Program for Managing Chronic Pain provided with different levels of clinical support.
Secondary ID [1] 282054 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
288530 0
Anxiety 288531 0
Depression 288532 0
Condition category
Condition code
Anaesthesiology 288864 288864 0 0
Pain management
Mental Health 288865 288865 0 0
Anxiety
Mental Health 288866 288866 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of four groups: (1) a clinician-initiated contact group, (2) a participant-initiated contact group, (3) a self-guided group, and a (4) waitlist control group, who begin the program as soon as the treatments group finish the program. All participants will meet diagnostic criteria for chronic pain (i.e. pain lasting longer than 6 months). All participants will complete 5 lessons of Internet based treatment about 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 the clinician-initiated contact group group will receive 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. Participants in the participant-initiated contact group will receive exactly the same materials and content except, instead of being contact by a clinican, they will have the option to contact or request contact with the eCentreClinic Psychologist themselves. In contrast, those in the Self-Guided Group will not receive contact with the Psychologist during the Course. In all other respects the Courses are identical. Participants in the waitlist control group will receive access to the Course after the treatment groups finish and will be provided with participant-initiated contact.

The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 3, 12 and 24 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] 286647 0
Treatment: Other
Intervention code [2] 286651 0
Behaviour
Comparator / control treatment
A waitlist control group who begin the treatment immediately after the treatment groups complete the Course.
Control group
Active

Outcomes
Primary outcome [1] 288990 0
Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
Timepoint [1] 288990 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Primary outcome [2] 288991 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 288991 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Primary outcome [3] 288992 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 288992 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [1] 301510 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 301510 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [2] 301511 0
Pain Things You Do Questionnaire (PTYDQ), which is a measure of helpful cognitive and behavioural skill use.
Timepoint [2] 301511 0
Pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [3] 301512 0
Employment and health service use will be measured by the Employment and Health Service Use Questionnaire
Timepoint [3] 301512 0
Pre-treatment and 3, 12 and 24 month follow-up.
Secondary outcome [4] 301513 0
Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
Timepoint [4] 301513 0
Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.
Secondary outcome [5] 301514 0
Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.
Timepoint [5] 301514 0
Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.
Secondary outcome [6] 301515 0
Chronic Pain Acceptance Questionnaire 8-item (CPAQ8), which measures acceptance of chronic pain.
Timepoint [6] 301515 0
Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.

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
100 Years
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)

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 286827 0
Government body
Name [1] 286827 0
Motor Accidents Authority of New South Wales
Address [1] 286827 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] 286827 0
Australia
Funding source category [2] 286828 0
Government body
Name [2] 286828 0
National Health and Medical Research Council (NHMRC)
Address [2] 286828 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 286828 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 285618 0
None
Name [1] 285618 0
Address [1] 285618 0
Country [1] 285618 0
Other collaborator category [1] 277307 0
Individual
Name [1] 277307 0
Associate Professor Nick Titov
Address [1] 277307 0
Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [1] 277307 0
Australia
Other collaborator category [2] 277308 0
Individual
Name [2] 277308 0
Dr Kathryn Nicholson Perry
Address [2] 277308 0
School of Psychology, University of Western Sydney, locked bag 1797, Penrith South DC, NSW 2751, Australia
Country [2] 277308 0
Australia
Other collaborator category [3] 277309 0
Individual
Name [3] 277309 0
Ms Milena Gandy
Address [3] 277309 0
Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [3] 277309 0
Australia
Other collaborator category [4] 277310 0
Individual
Name [4] 277310 0
Professor Louise Sharpe
Address [4] 277310 0
School of Psychology, Sydney University, Brennan MacCallum Building, NSW, 2006.
Country [4] 277310 0
Australia
Other collaborator category [5] 277311 0
Individual
Name [5] 277311 0
Professor Michael Nicholas
Address [5] 277311 0
Anaesthesia, Northern Clinical School, Kolling Institute of Medical Research, Royal North Shore Hospital, The University of Sydney, NSW 2006.
Country [5] 277311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288893 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 288893 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.
Ethics committee country [1] 288893 0
Australia
Date submitted for ethics approval [1] 288893 0
Approval date [1] 288893 0
14/02/2013
Ethics approval number [1] 288893 0
5201200872

Summary
Brief summary
This project builds on an earlier project and seeks to examine the efficacy and acceptability of the Pain Course when provided with different levels of clinical support. We expect that people in the treatment groups will report similar levels of clinical benefit and acceptability.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
- Dear, B. F., Titov, N., Nicholson Perry, K., Johnston, L., Wootton, B. M., Terides, M. D., Rapee, R. M., & Hudson, J. L. (submitted). The Pain Course: A randomised controlled trial of clinician-guided internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional wellbeing.
- Johnston, L., Titov, N., Andrews, G., Dear, B. F., & Spence, J. (submitted). Comorbidity and internet-delivered transdiagnostic cognitive behavioural therapy for anxiety disorders. Cognitive Behaviour Therapy.
- Dear, B. F., Titov, N., Schwencke, G., Andews, G., Johnston, L., Craske, M. G., & McEvoy, P. (2011). An open trial of a brief transdiagnostic treatment for anxiety and depression. Behaviour Research and Therapy, 49, 830-837.
- Johnston, L., Titov, N., Andrews, G., Spence, J., & Dear, B.F. (2011). A RCT of a transdiagnostic internet-delivered treatment for three anxiety disorders: Examination of support roles and disorder-specific outcomes. PLoS ONE 6(11): e28079.
- Titov N., Dear B.F., Schwencke G., Andrews G., Johnston L., Craske M., & McEvoy, P. (2011). Transdiagnostic Internet treatment of anxiety and depression: A randomised controlled trial. Behaviour Research and Therapy, 49, 441-452.
- Titov, N., Andrews, G., Johnston, L., Robinson, E., & Spence, J. (2010). Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial. Behaviour Research and Therapy, 48, 890-899.
Public notes

Contacts
Principal investigator
Name 38254 0
Dr Blake F. Dear
Address 38254 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 38254 0
Australia
Phone 38254 0
61 2 9850 9979
Fax 38254 0
61 2 9850 8062
Email 38254 0
blake.dear@mq.edu.au
Contact person for public queries
Name 38255 0
Dr Blake F. Dear
Address 38255 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 38255 0
Australia
Phone 38255 0
61 2 9850 9979
Fax 38255 0
61 2 9850 8062
Email 38255 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 38256 0
Dr Blake F. Dear
Address 38256 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 38256 0
Australia
Phone 38256 0
61 2 9850 9979
Fax 38256 0
61 2 9850 8062
Email 38256 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