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Trial registered on ANZCTR


Registration number
ACTRN12612000556842
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
25/05/2012
Date last updated
28/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open trial of examining the efficacy and acceptability of an internet-delivered cognitive behaviour therapy (CBT) program for chronic pain augmented with daily SMS prompts.
Scientific title
An open trial of examining the efficacy and acceptability of an internet-delivered cognitive behaviour therapy (CBT) program for chronic pain augmented with daily SMS prompts.
Secondary ID [1] 280530 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 286525 0
Anxiety 286548 0
Depression 286549 0
Condition category
Condition code
Anaesthesiology 286788 286788 0 0
Pain management
Mental Health 286789 286789 0 0
Depression
Mental Health 286790 286790 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 5 lessons of an Internet-delivered cognitive behaviour therapy (CBT) treatment focusing on the management of pain, anxiety, depression and disability. 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. All participants will also receive automatic email and weekly reminder phone calls by a clinical psychologist. The duration of the reminder emails and phone calls is expected to be 5-10 minutes per week. The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 10-20 minutes to complete. Participants will be invited to receive generic SMS prompts and consenting participants will start receiving these prompts from week 3 of the course. The SMS prompts will be brief, limited to 1 a day on week days, and designed to remind participants to practice the skills during the day.
Intervention code [1] 284906 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287160 0
Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
Timepoint [1] 287160 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 287161 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 287161 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 287162 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 287162 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 297523 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 297523 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 297524 0
Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.
Timepoint [2] 297524 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 297525 0
The Pain Responses Self Statements (PRSS), which is a measure of catastrophic pain-related cognitions.
Timepoint [3] 297525 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 297526 0
Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
Timepoint [4] 297526 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
- Has experienced Chronic Pain (i.e. Pain > 3 months)
- Internet access + Printer access
- Australian resident
- Has had their pain assessed by their GP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Psychotic disorder
- Pain not assessed by GP
- Current or planned psychological treatment during study duration

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, followed by a telephone interview to confirm presence of chronic pain and administration structured diagnostic interview using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
7/05/2012
Actual
7/05/2012
Date of last participant enrolment
Anticipated
7/05/2012
Actual
7/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285291 0
Government body
Name [1] 285291 0
Motor Accidents Authority of NSW
Country [1] 285291 0
Australia
Primary sponsor type
University
Name
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
Address
Macquarie University, Balaclava Road, North Ryde, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 284150 0
None
Name [1] 284150 0
Address [1] 284150 0
Country [1] 284150 0
Other collaborator category [1] 260808 0
Individual
Name [1] 260808 0
Associate Professor Nick Titov
Address [1] 260808 0
The eCentreClinic, Centre for Emotional Health (CEH), Department of Psychology, Macquarie University, Balaclava Road, North Ryde, NSW, 2109, Australia.
Country [1] 260808 0
Australia
Other collaborator category [2] 260809 0
Individual
Name [2] 260809 0
Dr Kathryn Nicholson Perry
Address [2] 260809 0
School of Psychology, University of Western Sydney, locked bag 1797, Penrith South DC, NSW 2751, Australia
Country [2] 260809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287303 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 287303 0
Human Research Ethics Committee
Macquarie University
NSW 2109
Ethics committee country [1] 287303 0
Australia
Date submitted for ethics approval [1] 287303 0
Approval date [1] 287303 0
06/02/2012
Ethics approval number [1] 287303 0
5201100476

Summary
Brief summary
This project is part of a research program to develop and evaluate an Internet-based education and treatment program for people with chronic pain. This project examines the efficacy and acceptability of a treatment program to enhance management of pain, anxiety, depression and disability amongst people with chronic pain, when augmented with daily SMS prompts reminder participants to practice self-management skills. We expect that participants will experience improvements across the measures and will rate the SMS prompts as acceptable and helpful.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
- Wootton, B. M., Titov, N., Dear, B. F., Spence, J., Andrews, G., & Solley, K. (in press). The Efficacy of an Internet Administered Treatment Program for Obsessive Compulsive Disorder: A Pilot Study.
- Dear, B. F., Sharpe, L., Nicholas, M., & Refshauge, K. (in press). The Psychometric Properties of the Dot-Probe Paradigm When Used in Pain-related Attentional Bias Research. The Journal of Pain.
- Dear, B. F., Titov, N., Sunderland, M., McMillan, D., Anderson, T., Lorian, C. & Robinson, E. (in press). Psychometric Comparison of the GAD-7 and the PSWQ for Measure Response During Treatment of Generalised Anxiety Disorder. Cognitive Behaviour Therapy.
- Spence, J., Titov, N., Dear, B. F., Johnston, L., Solley, K., Lorian, C., Wootton, B., Zou, J., & Schwenke, G. (2011). A Randomized Controlled Trial of Internet-based Cognitive Behaviour Therapy for Posttraumatic Stress Disorder. Depression and Anxiety, 28, 541-550.
- Spence, J., Titov, N., Solley, K., Dear, B. F., Johnston, L., Wootton, B., Kemp, A., Andrews, G., Zou, J., Lorian, C., & Choi, I. (2011). Characteristics and Treatment Preferences of People with Symptoms of Posttraumatic Stress Disorder: An Internet Survey. PLoS One, 6, e21864.
- Wootton, B. M., Titov, N., Dear, B. F., Spence, J., & Kemp, A. (2011). The Acceptability of Internet-Based Treatment and Characteristics of an Adult Sample with Obsessive Compulsive Disorder: An Internet Survey. PLoS One, 6, e20548.
- Titov, N., Dear, B. F., Schwencke, G., Andews, G., Johnston, L., Craske, M. G., & McEvoy, P. (2011). Transdiagnostic treatment for anxiety and depression: A randomised Controlled trial. Behaviour Research and Therapy, 49, 331-452.
- Titov, N., Dear, B. F., McMillan, D., Anderson, T., & Zou, J. (2011). Psychometric comparison of the PHQ-9 and BDI-II for measuring response during internet treatment of depression. Cognitive Behaviour Therapy, 40, 126-136.
- Dear, B. F., Sharpe, L., Nicholas, M., & Refshuage, K. (2011) Pain-related attentional biases: The importance of the personal relevance and ecological validity of stimuli. The Journal of Pain, 12, 625 – 632.
- Wootton, B. M., Titov, N., Dear, B. F., Spence, J., & Kemp, A. (2011). The Acceptability of Internet-Based Treatment and Characteristics of an Adult Sample with Obsessive Compulsive Disorder: An Internet Survey. PLoS One, 6.
- Sharpe, L., Nicholson Perry, K., Rogers, P., Dear, B. F., Nicholas, M. K., & Refshauge, K. (2010). A comparison of the effect of attention training and relaxation on responses to pain. Pain, 150, 469-476.
- Sharpe, L., Dear, B. F., & Schrieber, L. (2009). Attentional biases in chronic pain associated with rheumatoid arthritis: hypervigilance or difficulties disengaging. The Journal of Pain, 10, 329-335.
Public notes

Contacts
Principal investigator
Name 34209 0
Dr Blake Dear
Address 34209 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 34209 0
Australia
Phone 34209 0
61 2 9850 9979
Fax 34209 0
Email 34209 0
[email protected]
Contact person for public queries
Name 17456 0
Dr Blake F. Dear
Address 17456 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 17456 0
Australia
Phone 17456 0
61 2 9850 9979
Fax 17456 0
61 2 9850 8062
Email 17456 0
[email protected]
Contact person for scientific queries
Name 8384 0
Dr Blake F. Dear
Address 8384 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 8384 0
Australia
Phone 8384 0
61 2 9850 9979
Fax 8384 0
61 2 9850 8062
Email 8384 0
[email protected]

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