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Trial registered on ANZCTR


Registration number
ACTRN12615000660583
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
25/06/2015
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot trial evaluating a new online pain management program (Reboot Online Pain Program) for adults living with chronic pain.
Scientific title
A pilot trial evaluating the acceptability and effectiveness of a new online pain management program (Reboot Online Pain Program) for adults living with chronic pain.
Secondary ID [1] 286887 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 295291 0
Condition category
Condition code
Mental Health 295548 295548 0 0
Depression
Mental Health 295550 295550 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Reboot Online program contains 8 lessons over 12 weeks. It is a multi-disciplinary pain management program combining psychological cognitive behaviour therapy with a physical therapy component. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries after each lesson, homework exercises, view videos of physical exercises, expert talks, extra resources and have receive email contact from a clinician after the first two lessons, then as required. The participant is able to contact a clinician via phone or email throughout the program - they will be able to ask questions and receive guidance from a multidisciplinary team (a registered psychologist, physiotherapist, pain specialist 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] 292066 0
Behaviour
Intervention code [2] 292067 0
Treatment: Other
Comparator / control treatment
Nil - this is a pre-post study design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295271 0
Severity of pain and the impact of pain on daily function according to mean score on the Brief Pain Inventory (BPI).
Timepoint [1] 295271 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [1] 315238 0
Level of pain related disability according to mean score on the Pain Disability Index (BDI)
Timepoint [1] 315238 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [2] 315242 0
Changes in Fear and Avoidance of movement according to mean score on the Tampa Scale of Kinesiophobia (TSK).
Timepoint [2] 315242 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [3] 315243 0
Changes in catastrophic thoughts related in chronic pain according to mean score on the Pain Catastrophising scale (PCS).
Timepoint [3] 315243 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [4] 315244 0
Changes in a participant's perceived ability to manage their pain according to mean score on the Pain Self-efficacy Questionnaire (PSEQ).
Timepoint [4] 315244 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [5] 315245 0
Changes in depression symptom severity according to mean score on the Patient Health Questionnaire 9-item (PHQ-9).
Timepoint [5] 315245 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [6] 315246 0
Severity of psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [6] 315246 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).
Secondary outcome [7] 315247 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).
Timepoint [7] 315247 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment and at 3 months post-treatment (week 24).

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
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).

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)
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. Questions about the study will be answered and an offer of treatment made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised study. All participants that meet criteria for entry into the study who also provide informed consent, will be allocated to the online intervention group.
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
A pre-post improvement of effect size (ES) 0.8 is expected for the treatment group on severity of pain measured through the Brief Pain Inventory (BPI).

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

Funding & Sponsors
Funding source category [1] 291442 0
Hospital
Name [1] 291442 0
St Vincent's Hospital
Address [1] 291442 0
Clinical Research Unit for Anxiety and Depression
Level 4 O'Brien Centre,
St Vincent's Hospital,
390 Victoria Street
Darlinghurst, NSW 2010
Country [1] 291442 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Clinical Research Unit for Anxiety and Depression
Level 4 O'Brien Centre,
St Vincent's Hospital,
390 Victoria Street
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 290117 0
None
Name [1] 290117 0
Address [1] 290117 0
Country [1] 290117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292992 0
St Vincent's Hospital HREC
Ethics committee address [1] 292992 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 292992 0
Australia
Date submitted for ethics approval [1] 292992 0
09/02/2015
Approval date [1] 292992 0
05/06/2015
Ethics approval number [1] 292992 0
HREC/15/SVH/32

Summary
Brief summary
The project aims to evaluate the acceptability and clinical efficiency of the online Reboot Pain Program.

Up to 30 people with chronic pain (experiencing pain for more than 3 months) will be assigned to the active treatment group. The treatment group will commence the Reboot online program immediately.

The efficacy of the program will determined by comparing severity of pain levels before and after treatment and at 3-month follow up.
Trial website
Trial related presentations / publications
Draft paper still being finalized, we will update this field when publication has been completed
Public notes

Contacts
Principal investigator
Name 57978 0
Prof Gavin Andrews
Address 57978 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW, 2010
Country 57978 0
Australia
Phone 57978 0
+61 2 8382 1405
Fax 57978 0
Email 57978 0
gavina@unsw.eud.au
Contact person for public queries
Name 57979 0
Ms Jessica Smith
Address 57979 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW, 2010
Country 57979 0
Australia
Phone 57979 0
+61 2 8382 1421
Fax 57979 0
Email 57979 0
jessica.smith@svha.org.au
Contact person for scientific queries
Name 57980 0
Ms Jessica Smith
Address 57980 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW, 2010
Country 57980 0
Australia
Phone 57980 0
+61 2 8382 1421
Fax 57980 0
Email 57980 0
jessica.smith@svha.org.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