Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000146695
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study examining the effectiveness and acceptability of an internet-delivered education program, The Pain Course, for chronic pain patients with anxiety and depression in a tertiary pain service.
Scientific title
A feasibility study examining the effectiveness and acceptability of an internet-delivered education program, The Pain Course, for chronic pain patients with anxiety and depression in a tertiary pain service.
Secondary ID [1] 284011 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
 291044 0
Anxiety
 291087 0
Depression 291088 0
Condition category
Condition code
Anaesthesiology 291384 291384 0 0
Pain management
Mental Health 291385 291385 0 0
Depression
Mental Health 291386 291386 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 5 lessons of an internet-delivered cognitive behaviour therapy (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 weekly reminder emails and weekly 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, during the treatment, post-treatment, and 3 months post-treatment. These questionnaires at application, pre-treatment, post-treatment and 3-months follow up will take about 10 minutes to complete. The questionnaires administered during the treatment will take approximately 2 minutes to complete. The software presenting the iCBT treatment course will also record information to inform adherence to the intervention (e.g. lessons completed, download history of other treatment materials in the course, number of logins, and duration of logins).
Intervention code [1] 288694 0
Treatment: Other
Intervention code [2] 288727 0
Behaviour
Comparator / control treatment
N/A - This is a single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291374 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 291374 0
Application; pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [2] 291375 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 291375 0
Pre-treatment; once per week throughout treatment; post-treatment, and; 3 month follow-up
Primary outcome [3] 291376 0
Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.
Timepoint [3] 291376 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [1] 306622 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 306622 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [2] 306623 0
Pain Self-Efficacy Questionnaire (PSEQ) which is a measure of self-rated pain-related self-efficacy beliefs.
Timepoint [2] 306623 0
Pre-treatment; post-treatment, and; 3 month follow-up
Secondary outcome [3] 306624 0
Tampa Scale of Kinesiophobia (TSK), which is a measure of fear of movement and re-injury.
Timepoint [3] 306624 0
Pre-treatment; post-treatment, and; 3 month follow-up

Eligibility
Key inclusion criteria
- Has experienced Chronic Pain (i.e. Pain > 3 months)
- Self-reported difficulties with anxiety or depression.
- Internet access + Printer access
- Australian resident
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving concurrent CBT
- Severe symptoms of depression
- Severe depression, suicidal intent or plan (PHQ-9 total score > 23; or >2 to PHQ-9 question assessing frequency of self-harm or suicide ideation)

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 patients receiving treatment for chronic pain at the Pain Management Unit at Prince of Wales Hospital. Patients will be informed of the study by an invitation letter and the Participant Information Sheet delivered in person or by mail by nursing staff unrelated to the study. Participants returning consent forms will be contacted by a Clinical Psychologist in person or by phone at a time convenient to the participant to administer the PHQ-9 and a brief telephone interview to confirm the program is suitable for applicants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A. This is an open trial design.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2024 0
Prince of Wales Private Hospital - Randwick

Funding & Sponsors
Funding source category [1] 288631 0
Hospital
Name [1] 288631 0
Pain Management Unit, Prince of Wales Hospital
Country [1] 288631 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] 287338 0
None
Name [1] 287338 0
Address [1] 287338 0
Country [1] 287338 0
Other collaborator category [1] 277791 0
Individual
Name [1] 277791 0
Ms Catherine Courtney
Address [1] 277791 0
Pain Management Unit, Prince of Wales Hospital, Barker St, Randwick, NSW, 2031
Country [1] 277791 0
Australia
Other collaborator category [2] 277792 0
Individual
Name [2] 277792 0
Dr Blake Dear
Address [2] 277792 0
Department of Psychology, Macquarie University, NSW, 2109
Country [2] 277792 0
Australia
Other collaborator category [3] 277793 0
Individual
Name [3] 277793 0
Dr Luke James Johnston
Address [3] 277793 0
Department of Psychology, Macquarie University, NSW, 2109
Country [3] 277793 0
Australia
Other collaborator category [4] 277794 0
Individual
Name [4] 277794 0
Professor Nickolai Titov
Address [4] 277794 0
Department of Psychology, Macquarie University, NSW, 2109
Country [4] 277794 0
Australia
Other collaborator category [5] 277795 0
Individual
Name [5] 277795 0
Dr Kok Eng Khor
Address [5] 277795 0
Pain Management Unit, Prince of Wales Hospital, Barker St, Randwick, NSW, 2031
Country [5] 277795 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290488 0
NSW Health South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 290488 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 290488 0
Australia
Date submitted for ethics approval [1] 290488 0
Approval date [1] 290488 0
06/11/2013
Ethics approval number [1] 290488 0
13/175

Summary
Brief summary
This project builds on an earlier projects and seeks to examine the efficacy and acceptability of the Pain Course when provided in a tertiary pain service. We expect that participants will report improvements in symptoms of anxiety, depression and disability levels.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
- Dear, BF., Titov, N., Perry, KN., Johnston, L., Wootton, B., Terides, M., Rapee, R., Hudson, J. (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.
- 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.
Public notes

Contacts
Principal investigator
Name 45930 0
Ms Catherine Courtney
Address 45930 0
Pain Management Unit, Prince of Wales Hospital, Barker St, Randwick, NSW 2031
Country 45930 0
Australia
Phone 45930 0
61 2 9382 2958
Fax 45930 0
Email 45930 0
[email protected]
Contact person for public queries
Name 45931 0
Ms Catherine Courtney
Address 45931 0
Pain Management Unit, Prince of Wales Hospital, Barker St, Randwick, NSW 2031
Country 45931 0
Australia
Phone 45931 0
61 2 9382 2958
Fax 45931 0
Email 45931 0
[email protected]
Contact person for scientific queries
Name 45932 0
Dr Blake Dear
Address 45932 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 45932 0
Australia
Phone 45932 0
61 2 9850 9979
Fax 45932 0
Email 45932 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

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