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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
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Scientific title
A randomized controlled trial of internet based treatment for chronic pain and emotional wellbeing comparing immediate treatment vs. delayed treatment.
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Secondary ID [1]
262878
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Nil.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain.
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Anxiety
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Depression
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Condition category
Condition code
Anaesthesiology
270768
270768
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0
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Pain management
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Mental Health
270789
270789
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0
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Anxiety
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Mental Health
270791
270791
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
269232
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Other interventions
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
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Assessment method [1]
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Timepoint [1]
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Primary outcome [2]
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Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.
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Assessment method [2]
279465
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Timepoint [2]
279465
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Primary outcome [3]
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Depression, Anxiety and Stress Scale (DASS), which measures depression, anxiety and stress.
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Assessment method [3]
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Timepoint [3]
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [1]
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Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
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Assessment method [1]
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Timepoint [1]
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [2]
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Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
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Assessment method [2]
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Timepoint [2]
287695
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [3]
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The Pain Responses Self Statements (PRSS), which is a measure of catastrophic pain-related cognitions.
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Assessment method [3]
287696
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Timepoint [3]
287696
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [4]
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Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
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Assessment method [4]
287697
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Timepoint [4]
287697
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [5]
287698
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Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
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Assessment method [5]
287698
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Timepoint [5]
287698
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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Secondary outcome [6]
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The Orebro Musculoskeletal Pain Questionnaire (OMPQ), which is a screening questionnaire designed to identify a person's work situation and their functioning.
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Assessment method [6]
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Timepoint [6]
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Administered at pre-treatment, post-treatment, and at 3-months post-treatment
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/09/2011
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Actual
26/09/2011
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Date of last participant enrolment
Anticipated
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Actual
23/01/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Motor Accidents Authority of NSW
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Address [1]
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Motor Accidents Authority
Level 25, 580 George Street
Sydney NSW 2000, Australia
DX: DX 1517 SYDNEY
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Country [1]
269700
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Australia
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Primary sponsor type
University
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Name
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
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Address
Macquarie University, NSW, 2109, Australia.
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
268738
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Country [1]
268738
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Other collaborator category [1]
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Individual
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Name [1]
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Dr Kathryn Nicholson Perry
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Address [1]
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School of Psychology, University of Western Sydney, locked bag 1797, Penrith South DC, NSW 2751, Australia
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Country [1]
252216
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Australia
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Other collaborator category [2]
252217
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Individual
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Name [2]
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Associate Professor Nick Titov
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Address [2]
252217
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The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
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Country [2]
252217
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Macquarie University, HUman Research Ethics Committee
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Ethics committee address [1]
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Human Research Ethics Committee Macquarie University NSW 2109
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
271663
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Approval date [1]
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13/05/2011
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Ethics approval number [1]
271663
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5201100476
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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.
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Trial website
www.ecentreclinic.org
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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.
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Public notes
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Contacts
Principal investigator
Name
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Dr Blake Dear
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Address
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The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
33046
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Australia
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Phone
33046
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61 2 9850 9979
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Fax
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Email
33046
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[email protected]
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Contact person for public queries
Name
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Dr Blake F. Dear
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Address
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The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
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Australia
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Phone
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61 2 9850 9979
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Fax
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61 2 9850 8062
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Blake F. Dear
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Address
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The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
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Australia
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Phone
7221
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61 2 9850 9979
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Fax
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61 2 9850 8062
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Email
7221
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[email protected]
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No information has been provided regarding IPD availability
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.
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