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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.
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.
Secondary ID [1] 283036 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
 289870 0
Anxiety 289871 0
Depression 289872 0
Condition category
Condition code
Anaesthesiology 290231 290231 0 0
Pain management
Mental Health 290232 290232 0 0
Depression
Mental Health 290233 290233 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287756 0
Treatment: Other
Comparator / control treatment
N/A - This is a single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290251 0
Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
Timepoint [1] 290251 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Primary outcome [2] 290252 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 290252 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Primary outcome [3] 290253 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 290253 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [1] 304211 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 304211 0
Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [2] 304212 0
Pain Things You Do Questionnaire (PTYDQ), which is a measure of helpful cognitive and behavioural skill use.
Timepoint [2] 304212 0
Pre-treatment, post-treatment and 3, 12 and 24 month follow-up
Secondary outcome [3] 304213 0
Employment and health service use will be measured by the Employment and Health Service Use Questionnaire
Timepoint [3] 304213 0
Pre-treatment and 3, 12 and 24 month follow-up.

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
No limit
Sex
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
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/a.
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
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/06/2013
Date of last participant enrolment
Anticipated
3/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287797 0
Government body
Name [1] 287797 0
Motor Accidents Authority of New South Wales
Country [1] 287797 0
Australia
Funding source category [2] 287798 0
University
Name [2] 287798 0
Macquarie University
Country [2] 287798 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 286528 0
None
Name [1] 286528 0
Address [1] 286528 0
Country [1] 286528 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42226 0
Dr Blake F. Dear
Address 42226 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 42226 0
Australia
Phone 42226 0
61 2 9850 9979
Fax 42226 0
Email 42226 0
blake.dear@mq.edu.au
Contact person for public queries
Name 42227 0
Blake F. Dear
Address 42227 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 42227 0
Australia
Phone 42227 0
61 2 9850 9979
Fax 42227 0
Email 42227 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 42228 0
Blake F. Dear
Address 42228 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 42228 0
Australia
Phone 42228 0
61 2 9850 9979
Fax 42228 0
Email 42228 0
blake.dear@mq.edu.au

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.