ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000252718

Ethics application status

Approved

Date submitted

1/03/2013

Date registered

4/03/2013

Date last updated

23/06/2021

Date data sharing statement initially provided

23/06/2021

Date results provided

23/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The Pain Course: A Randomised Controlled Trial assessing the efficacy and acceptability of an Internet Delivered-Treatment Program for Managing Chronic Pain provided with different levels of clinical support.

Scientific title

The Pain Course: A Randomised Controlled Trial assessing an Internet Delivered-Treatment Program for Managing Chronic Pain provided with different levels of clinical support.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Pain

Anxiety

Depression

Condition category

Condition code

Anaesthesiology

Pain management

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomly assigned to one of four groups: (1) a clinician-initiated contact group, (2) a participant-initiated contact group, (3) a self-guided group, and a (4) waitlist control group, who begin the program as soon as the treatments group finish the program. All participants will meet diagnostic criteria for chronic pain (i.e. pain lasting longer than 6 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.

Participants in the clinician-initiated contact group group will receive weekly telephone calls or emails from a trained and supervised Psychologist at the eCentreClinic to provide support, encouragement and to answer questions about the content of the Course. Participants in the participant-initiated contact group will receive exactly the same materials and content except, instead of being contact by a clinican, they will have the option to contact or request contact with the eCentreClinic Psychologist themselves. In contrast, those in the Self-Guided Group will not receive contact with the Psychologist during the Course. In all other respects the Courses are identical. Participants in the waitlist control group will receive access to the Course after the treatment groups finish and will be provided with participant-initiated contact.

The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 3, 12 and 24 month follow-up. Some questionnaires will be administered weekly during the Course. The major sets of questionnaires will take about 10 to 15 minutes to complete. The treatment materials are based on previous internet-based programs, which apply cognitive behavioural techniques.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

A waitlist control group who begin the treatment immediately after the treatment groups complete the Course.

Control group

Active

Outcomes

Primary outcome [1]

Roland Morris Disability Questionnaire (RMDQ), which measures disability associated with pain.

Timepoint [1]

Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up

Primary outcome [2]

Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.

Timepoint [2]

Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up

Primary outcome [3]

Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.

Timepoint [3]

Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up

Secondary outcome [1]

Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.

Timepoint [1]

Application, pre-treatment, post-treatment and 3, 12 and 24 month follow-up

Secondary outcome [2]

Pain Things You Do Questionnaire (PTYDQ), which is a measure of helpful cognitive and behavioural skill use.

Timepoint [2]

Pre-treatment, post-treatment and 3, 12 and 24 month follow-up

Secondary outcome [3]

Employment and health service use will be measured by the Employment and Health Service Use Questionnaire

Timepoint [3]

Pre-treatment and 3, 12 and 24 month follow-up.

Secondary outcome [4]

Pain Self-Efficacy Questionnaire (PSEQ), which is a measure of peoples' beliefs about their ability to do daily activities despite pain.

Timepoint [4]

Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.

Secondary outcome [5]

Tampa Scale of Kinesiophobia (TAMPA), which measures fear of movement because of pain.

Timepoint [5]

Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.

Secondary outcome [6]

Chronic Pain Acceptance Questionnaire 8-item (CPAQ8), which measures acceptance of chronic pain.

Timepoint [6]

Pre-treatment and post-treatment. That is, immediately prior to participants starting the Course and 9 weeks later, immediately after the Course finishes.

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

100 Years

Sex

Both males and females

Can healthy volunteers participate?

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

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.

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) using permuted block randomisation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/03/2013

Actual

10/04/2013

Date of last participant enrolment

Anticipated

Actual

30/06/2014

Date of last data collection

Anticipated

Actual

31/08/2016

Sample size

Target

450

Accrual to date

Final

490

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Motor Accidents Authority of New South Wales

Address [1]

Motor Accidents Authority of NSW
Address: Motor Accidents Authority
Level 25, 580 George Street
Sydney NSW 2000, Australia
DX: DX 1517 SYDNEY

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council (NHMRC)

Address [2]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Associate Professor Nick Titov

Address [1]

Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Kathryn Nicholson Perry

Address [2]

School of Psychology, University of Western Sydney, locked bag 1797, Penrith South DC, NSW 2751, Australia

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Ms Milena Gandy

Address [3]

Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Professor Louise Sharpe

Address [4]

School of Psychology, Sydney University, Brennan MacCallum Building, NSW, 2006.

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Professor Michael Nicholas

Address [5]

Anaesthesia, Northern Clinical School, Kolling Institute of Medical Research, Royal North Shore Hospital, The University of Sydney, NSW 2006.

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University, HUman Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/02/2013

Ethics approval number [1]

5201200872

Summary

Brief summary

This project builds on an earlier project and seeks to examine the efficacy and acceptability of the Pain Course when provided with different levels of clinical support. We expect that people in the treatment groups will report similar levels of clinical benefit and acceptability.

Trial website

www.ecentreclinic.org

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. (submitted). The Pain Course: A randomised controlled trial of clinician-guided internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional wellbeing. 
- 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.

Public notes

Contacts

Principal investigator

Name

Dr Blake F. Dear

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

61 2 9850 9979

Fax

61 2 9850 8062

blake.dear@mq.edu.au

Contact person for public queries

Name

Blake F. Dear

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

61 2 9850 9979

Fax

61 2 9850 8062

blake.dear@mq.edu.au

Contact person for scientific queries

Name

Blake F. Dear

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

61 2 9850 9979

Fax

61 2 9850 8062

blake.dear@mq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	The pain course: A randomised controlled trial examining an internet-delivered pain management program when provided with different levels of clinician support.	2015	https://dx.doi.org/10.1097/j.pain.0000000000000251
Embase	Short message service prompts for skills practice in Internet-delivered cognitive behaviour therapy for chronic pain - are they feasible and effective?.	2016	https://dx.doi.org/10.1002/ejp.853
Embase	The Pain Course: Exploring predictors of clinical response to an Internet-delivered pain management program.	2016	https://dx.doi.org/10.1097/j.pain.0000000000000639
Embase	The Pain Course: 12- and 24-Month Outcomes From a Randomized Controlled Trial of an Internet-Delivered Pain Management Program Provided With Different Levels of Clinician Support.	2018	https://dx.doi.org/10.1016/j.jpain.2018.07.005
Embase	Involvement in compensation litigation and outcome from an online pain management program.	2019	https://dx.doi.org/10.1037/rep0000262
Embase	Whether chronic pain is medically explained or not does not moderate the response to cognitive-behavioural therapy.	2019	https://dx.doi.org/10.1016/j.jpsychores.2019.03.182
Embase	A Cost-effectiveness Analysis of an Internet-delivered Pain Management Program Delivered With Different Levels of Clinician Support: Results From a Randomised Controlled Trial.	2021	https://dx.doi.org/10.1016/j.jpain.2020.11.003

N.B. These documents automatically identified may not have been verified by the study sponsor.

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