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Trial registered on ANZCTR


Registration number
ACTRN12616000249459
Ethics application status
Approved
Date submitted
19/02/2016
Date registered
23/02/2016
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Reboot Online Pain Management Program for chronic pain
Scientific title
A randomised controlled trial evaluating the impact of an online multi-disciplinary pain management program ('Reboot Online') for chronic pain.
Secondary ID [1] 288572 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 297706 0
Condition category
Condition code
Neurological 297879 297879 0 0
Other neurological disorders
Mental Health 297880 297880 0 0
Other mental health disorders
Anaesthesiology 297891 297891 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Reboot Online program contains 8 lessons over
16 weeks delivering 'self-management' techniques in order to manage chronic pain better. The 'self-management' techniques are based on the components of a multi-disciplinary pain management program combining psychological cognitive behaviour therapy and a physical therapy component. Participants will learn skills to manage their pain based on these components, for example Pacing through a graded exercise program - the physical therapy component - alongside psychological skills and techniques such as Activity Scheduling, Thought Challenging and Stress Reduction. One lesson will be completed every 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons). The participant does not have to complete the whole lesson in one sitting. Each lesson will take approximately 30-40 minutes to complete. Participants will access summaries after each lesson which contain homework exercises - this entails the participant practicing and implementing the skills that have been covered within the lesson content.The participant can also optionally view videos of physical exercises, expert talks and extra resources. There is no specific time requirement for the homework tasks but it is recommended that the participants spend roughly 3-4 hours per week re-reading the lesson content and resources, reviewing the homework summaries and practicing the skills in the program. All participants will receive email
contact from a clinician after the first two lessons then as required. The participant is able to contact a clinician via telephone or email throughout the program - they will have access to a registered psychologist, physiotherapist, anesthetist and psychiatrist. The participant completes a measure of psychological distress before each lesson and if their
scores increase by one or more standard deviation the clinician is automatically alerted and initiates contact with the participant by phone or email. Strategies used to improve adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework and videos,
collection of data on how long participants spent reading the lessons and practicing the skills.
Intervention code [1] 293958 0
Behaviour
Intervention code [2] 293963 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU) waitlist control group. These participants remain on the waitlist and receive their usual treatment for chronic pain until the immediate treatment group has completed their treatment (16 weeks), post-treatment questionnaires (17 weeks) and three month follow-up. At week 30, the waitlist control group will be offered the online treatment program for pain. For all study participants, their chronic pain treatment will not change and will continue as usual "treatment as usual". For example, as part of usual treatment, participants will continue to receive regular monitoring from their appropriate physicians (and associated pain services like physiotherapy) and medication management from their GP or pain specialist.
Control group
Active

Outcomes
Primary outcome [1] 297404 0
Severity of pain and interference according to mean scores on the Brief Pain Inventory (BPI) - two constructs within one measure.
Timepoint [1] 297404 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Primary outcome [2] 297423 0
Changes in a participant's perceived ability to manage their pain according to mean score on the Pain Self-Efficacy Questionnaire (PSEQ).
Timepoint [2] 297423 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [1] 320971 0
Level of pain related disability according to mean score on the Pain
Disability Index (PDI).
Timepoint [1] 320971 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [2] 320994 0
Changes in Fear and Avoidance of movement according to mean score
on the Tampa Scale of Kinesiophobia (TSK).
Timepoint [2] 320994 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [3] 320995 0
Changes in catastrophic thoughts related in chronic pain according to
mean score on the Pain Catastrophising scale (PCS).
Timepoint [3] 320995 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [4] 320996 0
Participant overall mood assessed via mean scores on the Patient Health Questionnaire 9-item (PHQ-9).
Timepoint [4] 320996 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [5] 320997 0
Severity of psychological distress according to mean scores on the
Kessler-10 (K10).
Timepoint [5] 320997 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [6] 320998 0
Changes in measures of depressive, anxiety and stress symptoms
according to mean scores on the Depression, Anxiety and Stress 21-item
scale (DASS-21) - composite secondary outcome measure.
Timepoint [6] 320998 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [7] 320999 0
Changes in Fear-avoidance beliefs according to mean scores on the Fear Avoidance Beliefs Questionnaire (FABQ).
Timepoint [7] 320999 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).
Secondary outcome [8] 321000 0
Changes in acceptance of chronic pain as measured on the Chronic Pain Acceptance Questionnaire (CPAQ).
Timepoint [8] 321000 0
Baseline, mid-treatment (before Lesson 5 for the immediate internet treatment group and Week 8 for the Treatment as Usual Group), one week post treatment (week 17) and at 3 months post-treatment (3 month follow-up = week 29).

Eligibility
Key inclusion criteria
*Self-identified as experiencing persistent pain for more than 3 months.
*Meet criteria for chronic pain.
*Resident in Australia.
*18 years and over.
*Has access to a computer, internet and a printer.
*Prepared to provide name, phone number and address of local general practitioner.
*If taking medication, must have been taking it for at least 3 months.
*Pain must have been assessed by a doctor within the last 3 months.
*Willing to provide informed consent
*Fluent in written and spoken English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Has not experienced pain for at least 3 months
*Has impending medical procedures scheduled within the next 6 months.
*Pain has not been assessed by a doctor in the last 3 months.
*Actively suicidal.
*Currently experiencing a psychotic mental illness or bipolar disorder.
*Not fluent in English (written and spoken).
*Currently experiencing severe depression symptoms
*Completed a group-based pain management program within the past 6 months
*Not willing to provide local GP contact details.

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)
Applicants apply online, and complete an automated screening
questionnaire. Applicants who meet inclusion criteria will be telephoned
to confirm chronic pain diagnosis with a structured interview.
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.
Allocation concealment will occur in the following way: A staff member
not involved in the clinical trial will generate the sequence using
computer software and place each choice in a sequentially numbered,
opaque sealed and stapled envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A pre-to-post-treatment improvement of effect size (ES) 0.8 is expected for the Reboot online treatment group on the primary measures. This group is also expected to improve more than the control group by an ES of 0.6. Sample size is powered to have an 80% chance of detecting differences at p<.05. Assuming effect size >0.6, power at 80%, and alpha set at 0.05, a sample size of 44 per group is needed to detect between-groups differences. Therefore, a sample of N=100 will allow for a 20% attrition rate. Clinical efficacy will be evaluated using two statistical analysis methods in order for the equivalence of these methods to be determined – mixed model repeated measures ANOVA and sequential method analysis. Mixed-model repeated measures (MMRM) ANOVA will be conducted with measurement occasion as a within-groups factor and treatment condition as a between-groups factor. Separate analyses will be conducted for pain severity. All analyses will control for pre-treatment symptom severity. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each symptom type, planned contrasts will be used to compare changes from baseline to post-treatment and 3-month follow-up. T-tests and chi-squared analyses will be used to determine equivalence between groups on pre-treatment scores and demographics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 5293 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 292920 0
Hospital
Name [1] 292920 0
St Vincent's Hospital
Address [1] 292920 0
390 Victoria Street,
Darlinghurst,
NSW
2010
Country [1] 292920 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street,
Darlinghurst,
NSW
2010
Country
Australia
Secondary sponsor category [1] 291676 0
None
Name [1] 291676 0
Address [1] 291676 0
Country [1] 291676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294425 0
St Vincent's Hospital
Ethics committee address [1] 294425 0
390 Victoria St,
Darlinghurst
NSW, 2010
Ethics committee country [1] 294425 0
Australia
Date submitted for ethics approval [1] 294425 0
09/02/2015
Approval date [1] 294425 0
05/06/2015
Ethics approval number [1] 294425 0
HREC/15/SVH/32

Summary
Brief summary
The project aims to evaluate the acceptability and clinical efficacy of an online Pain Program Management program, 'Reboot' online. And to examine the moderators and
mediators of change during the Reboot program.
Up to 100 people with chronic pain will be randomly assigned to either
the active treatment group or a Treatment as Usual (TAU) control group. The treatment group will commence the Reboot program immediately, whereas the TAU group will commence once the treatment group has completed and a 3 month follow-up period has been completed.
The efficacy of the Reboot program will be determined by comparing
the pain severity, disability and interference levels of the two groups at the time the
treatment group completes treatment. Mediation analyses will be used to
explore the role of variables that may influence positive change.
Trial website
Trial related presentations / publications
Trial results currently being analyzed, we will up[date this field once publication has been accepted
Public notes

Contacts
Principal investigator
Name 63666 0
Prof Gavin Andrews
Address 63666 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital,
390 Victoria Street,
Darlinghurst, NSW
2010
Country 63666 0
Australia
Phone 63666 0
+61 2 8382 1400
Fax 63666 0
+61 2 8382 1401
Email 63666 0
gavina@unsw.edu.au
Contact person for public queries
Name 63667 0
Prof Gavin Andrews
Address 63667 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital,
390 Victoria Street,
Darlinghurst, NSW
2010
Country 63667 0
Australia
Phone 63667 0
+61 2 8382 1400
Fax 63667 0
+61 2 8382 1401
Email 63667 0
gavina@unsw.edu.au
Contact person for scientific queries
Name 63668 0
Prof Gavin Andrews
Address 63668 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital,
390 Victoria Street,
Darlinghurst, NSW
2010
Country 63668 0
Australia
Phone 63668 0
+61 2 8382 1400
Fax 63668 0
+61 2 8382 1401
Email 63668 0
gavina@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary