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Trial registered on ANZCTR


Registration number
ACTRN12611000894998
Ethics application status
Approved
Date submitted
19/08/2011
Date registered
22/08/2011
Date last updated
28/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pain Program: A Randomised Controlled Trial of an Internet Delivered Treatment Program for Managing Chronic Pain and Emotional Wellbeing
Scientific title
A randomized controlled trial of internet based treatment for chronic pain and emotional wellbeing comparing immediate treatment vs. delayed treatment.
Secondary ID [1] 262878 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain. 270607 0
Anxiety 270622 0
Depression 270623 0
Condition category
Condition code
Anaesthesiology 270768 270768 0 0
Pain management
Mental Health 270789 270789 0 0
Anxiety
Mental Health 270791 270791 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) an immediate treatment group, or; 2) a delayed treatment group also known as a waitlist control group (beginnning the program 9 weeks after the immediate treatment group begin). All participants will meet diagnostic criteria for chronic pain (i.e. pain lasting longer than 3 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. All participants will also receive automatic email and weekly reminder phone calls by a clinical psychologist, and have access to a clinician-moderated online forum discussing content of the program. The duration of the reminder emails/phone calls and contribution to the forum is expected to be 5-10 minutes per week. The duration of the program is 8 weeks, but participants in the immediate treatment group will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20-30 minutes to complete. The treatment materials are based on previous internet-based programs, which apply cognitive behavioural techniques.
Intervention code [1] 269232 0
Other interventions
Comparator / control treatment
The delayed treatment group (beginnning the program 9 weeks after the immediate treatment group begins). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 279464 0
Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
Timepoint [1] 279464 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 279465 0
Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.
Timepoint [2] 279465 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 279466 0
Depression, Anxiety and Stress Scale (DASS), which measures depression, anxiety and stress.
Timepoint [3] 279466 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 287694 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 287694 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 287695 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 287695 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 287696 0
The Pain Responses Self Statements (PRSS), which is a measure of catastrophic pain-related cognitions.
Timepoint [3] 287696 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 287697 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [4] 287697 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 287698 0
Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
Timepoint [5] 287698 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [6] 287699 0
The Orebro Musculoskeletal Pain Questionnaire (OMPQ), which is a screening questionnaire designed to identify a person's work situation and their functioning.
Timepoint [6] 287699 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
- Current use of benzodiazepines or beta-blockers.

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, 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). Allocation concealment will occur by providing allocation details for each successive participant in a sealed envelope, 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), at another site, in another country. The list will then be transcribed and details transferred to sealed envelopes.
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
Completed
Date of first participant enrolment
Anticipated
26/09/2011
Actual
26/09/2011
Date of last participant enrolment
Anticipated
Actual
23/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269700 0
Government body
Name [1] 269700 0
Motor Accidents Authority of NSW
Country [1] 269700 0
Australia
Primary sponsor type
University
Name
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
Address
Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 268738 0
None
Name [1] 268738 0
Address [1] 268738 0
Country [1] 268738 0
Other collaborator category [1] 252216 0
Individual
Name [1] 252216 0
Dr Kathryn Nicholson Perry
Address [1] 252216 0
School of Psychology, University of Western Sydney, locked bag 1797, Penrith South DC, NSW 2751, Australia
Country [1] 252216 0
Australia
Other collaborator category [2] 252217 0
Individual
Name [2] 252217 0
Associate Professor Nick Titov
Address [2] 252217 0
The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
Country [2] 252217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271663 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 271663 0
Human Research Ethics Committee
Macquarie University
NSW 2109
Ethics committee country [1] 271663 0
Australia
Date submitted for ethics approval [1] 271663 0
Approval date [1] 271663 0
13/05/2011
Ethics approval number [1] 271663 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 preliminary project examines the efficacy and acceptability of a treatment program to enhance management of pain, anxiety, depression and disability amongst people with chronic pain. We expect that people in either immediate or delayed treatment groups will report similar benefit following the active component of their program.
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 33046 0
Dr Blake Dear
Address 33046 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 33046 0
Australia
Phone 33046 0
61 2 9850 9979
Fax 33046 0
Email 33046 0
blake.dear@mq.edu.au
Contact person for public queries
Name 16293 0
Dr Dr Blake F. Dear
Address 16293 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 16293 0
Australia
Phone 16293 0
61 2 9850 9979
Fax 16293 0
61 2 9850 8062
Email 16293 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 7221 0
Dr Dr Blake F. Dear
Address 7221 0
The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 7221 0
Australia
Phone 7221 0
61 2 9850 9979
Fax 7221 0
61 2 9850 8062
Email 7221 0
blake.dear@mq.edu.au

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