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Trial registered on ANZCTR
Registration number
ACTRN12613000926730
Ethics application status
Approved
Date submitted
19/08/2013
Date registered
22/08/2013
Date last updated
22/08/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Augmenting internet-delivered cognitive behaviour therapy (iCBT) with daily SMS prompts for adults with chronic pain: an open trial to examine efficacy and acceptability.
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Scientific title
Augmenting internet-delivered cognitive behaviour therapy (iCBT) with daily SMS prompts for adults with chronic pain: an open trial to examine efficacy and acceptability.
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Secondary ID [1]
283036
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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
290231
290231
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0
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Pain management
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Mental Health
290232
290232
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0
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Depression
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Mental Health
290233
290233
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will complete 5 lessons of an iCBT treatment, the Pain Course (Dear et al., 2013) focusing on the management of pain, anxiety, depression and disability. All 5 Lessons will be administered online (via the internet) and 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-treatment, post-treatment, and then 3, 12 and 24-months post-treatment. These questionnaires will take about 10 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.
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Intervention code [1]
287756
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Treatment: Other
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Comparator / control treatment
N/A - This is a single group study.
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Control group
Uncontrolled
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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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Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
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Primary outcome [2]
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Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
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Assessment method [2]
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Timepoint [2]
290252
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Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
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Primary outcome [3]
290253
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Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
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Assessment method [3]
290253
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Timepoint [3]
290253
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Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
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Secondary outcome [1]
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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 [1]
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Timepoint [1]
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Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
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Secondary outcome [2]
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Pain Things You Do Questionnaire (PTYDQ), which is a measure of helpful cognitive and behavioural skill use.
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Assessment method [2]
304212
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Timepoint [2]
304212
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Pre-treatment, post-treatment and 3, 12 and 24 month follow-up
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Secondary outcome [3]
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Employment and health service use will be measured by the Employment and Health Service Use Questionnaire
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Assessment method [3]
304213
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Timepoint [3]
304213
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Pre-treatment and 3, 12 and 24 month follow-up.
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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.
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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
- Active psychosis
- Pain not assessed by GP
- Severe depression, suicidal intent or plan (PHQ-9 total score > 22)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be the Waitlist-Control Group from another trial (ACTRN12613000252718). Participants receive access to the iCBT treatment once the Treatment Groups from the initial trial complete post-treatment and enter the follow-up phase.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/a.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Mixed linear models analyses will be conducted on the symptom outcome measures. With a alpha at 0.05 and power set at 80%, 27 participants are needed to detect a within-group effect size of .50, which is smaller than the smallest within-groups effect observed in a previous trial of the Pain Course. However, to hedge against attrition and to ensure the results are robust, more than 50 participants will be recruited.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
3/06/2013
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Date of last participant enrolment
Anticipated
3/06/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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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 New South Wales
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Address [1]
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Motor Accidents Authority of NSW
Address: Motor Accidents Authority
Level 25, 580 George Street
Sydney NSW 2000, Australia
DX: DX 1517 SYDNEY
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Country [1]
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Australia
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Funding source category [2]
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University
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Name [2]
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Macquarie University
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Address [2]
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eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country [2]
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Australia
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Primary sponsor type
Government body
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Name
National Health and Medical Research Council (NHMRC)
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Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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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]
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Country [1]
286528
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Ethics approval
Ethics application status
Approved
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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 project extends an earlier trial (ACTRN12612000556842) to examine the efficacy and acceptability an iCBT program for people with chronic pain, when augmented with daily SMS prompts reminder participants to practice self-management skills.
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Trial website
www.ecentreclinic.org
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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. (2013). The Pain Course: A randomised controlled trial of clinician-guided internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional wellbeing. Pain, 154, 942-950.
- 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.
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Public notes
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Contacts
Principal investigator
Name
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Dr Blake F. Dear
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Address
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eCentreClinic, 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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Email
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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
42227
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eCentreClinic, 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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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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eCentreClinic, 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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Email
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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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