Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000767606
Ethics application status
Approved
Date submitted
9/07/2014
Date registered
18/07/2014
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The SCI Pain Course: Examining a low-intensity self-management program for chronic pain and emotional wellbeing among adults with spinal cord injuries.
Scientific title
The SCI Pain Course: Examining a low-intensity self-management program for chronic pain and emotional wellbeing among adults with spinal cord injuries.
Secondary ID [1] 284958 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
 292446 0
Anxiety 292447 0
Depression 292448 0
Condition category
Condition code
Anaesthesiology 292760 292760 0 0
Pain management
Mental Health 292761 292761 0 0
Anxiety
Mental Health 292762 292762 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 5 lessons of an iCBT treatment, the SCI Pain Course (see Dear et al., 2013) focusing on the management of pain, anxiety, depression and disability. All 5 Lessons will be administered 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-months post-treatment. These questionnaires will take about 10 minutes to complete.
Intervention code [1] 289785 0
Behaviour
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292606 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 292606 0
Application, pre-treatment, mid-treatment, post-treatment and 3-month follow-up
Primary outcome [2] 292607 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 292607 0
Application, pre-treatment, mid-treatment, post-treatment and 3-month follow-up
Primary outcome [3] 292608 0
Pain Disability Index (PDI), which measures disability associated with pain.
Timepoint [3] 292608 0
Application, pre-treatment, mid-treatment, post-treatment and 3-month follow-up
Secondary outcome [1] 309325 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 309325 0
Application, pre-treatment, mid-treatment, post-treatment and 3-month follow-up
Secondary outcome [2] 309326 0
Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.
Timepoint [2] 309326 0
Pre-treatment, post-treatment and 3-month follow-up
Secondary outcome [3] 309327 0
The Pain Catastrophizing Scale (PCS), which is a widely used measure to assess a negative mental set.
Timepoint [3] 309327 0
Pre-treatment, post-treatment and 3-month follow-up
Secondary outcome [4] 309328 0
Employment and health service use will be measured by the Employment and Health Service Use Questionnaire
Timepoint [4] 309328 0
Pre-treatment, post-treatment and 3-month follow-up
Secondary outcome [5] 309329 0
Satisfaction with Life Scale (SWLS), which is a measure of satisfaction with life.
Timepoint [5] 309329 0
Pre-treatment, post-treatment and 3-month follow-up

Eligibility
Key inclusion criteria
(a) Diagnosed with a spinal cord injury;
(b) Experienced chronic pain for longer than 6 months or is experiencing anxiety and depression;
(c) Has had a recent consultation (i.e., in the last 6 months) with a GP or specialist;
(d) Is living in Australia;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Severe depression (i.e., indicated by a score > 22 on the PHQ-9)
(b) Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
(c) Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)

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 via the clinic's website (www.ecentreclinic.org). Successful applications are followed by a telephone interview to confirm suitability for the trial. Suitable participants will be provided with login details and a start date for the program.
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
All analyses will be carried out using conservative intention-to-treat principles and using mixed-linear models analyses to handle missing data. Mixed-models are a robust statistical approach for analysing clinical trial data and these analyses will employ an appropriate covariance structure and maximum likelihood estimation, which provides unbiased estimates in the case of missing data; under the assumption that data is missing at random.

Sample size: With an alpha at 0.05 and power set at 0.80, 27 participants are needed to detect an effect size improvement in symptoms of .50. However, to hedge against attrition 30 participants will be recruited. The effect size of 0.50 is also conservative estimate with larger effect sizes having been observed in previous trials (e.g., see Dear et al., 2013; Pain).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
10/04/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
4/06/2017
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
30
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289580 0
Government body
Name [1] 289580 0
Lifetime Care and Support Authority
Country [1] 289580 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 288264 0
Government body
Name [1] 288264 0
Lifetime Care and Support Authority
Address [1] 288264 0
Lifetime Care and Support Authority
Motor Accidents Authority of NSW
Address: Motor Accidents Authority
Level 25, 580 George Street
Sydney NSW 2000, Australia
DX: DX 1517 SYDNEY
Country [1] 288264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291316 0
Macquarie University, Human Research Ethics Committee
Ethics committee address [1] 291316 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.
Ethics committee country [1] 291316 0
Australia
Date submitted for ethics approval [1] 291316 0
Approval date [1] 291316 0
30/06/2014
Ethics approval number [1] 291316 0
5201400591

Summary
Brief summary
The proposed project seeks to examine the acceptability, efficacy and feasibility of low-intensity CBT-based self-management program, the SCI Pain Course, in reducing symptoms of anxiety, depression and disability among adults with spinal cord injuries. The SCI Pain Course is based on the already established and efficacious Pain Course but has undergone minor modification to make it optimally suitable for people with SCI.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49842 0
Dr Blake Dear
Address 49842 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49842 0
Australia
Phone 49842 0
+61 2 9850 9979
Fax 49842 0
Email 49842 0
[email protected]
Contact person for public queries
Name 49843 0
Dr Blake Dear
Address 49843 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49843 0
Australia
Phone 49843 0
+61 2 9850 9979
Fax 49843 0
Email 49843 0
[email protected]
Contact person for scientific queries
Name 49844 0
Dr Blake Dear
Address 49844 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country 49844 0
Australia
Phone 49844 0
+61 2 9850 9979
Fax 49844 0
Email 49844 0
[email protected]

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
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Documents added automatically
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