Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000363785
Ethics application status
Approved
Date submitted
6/03/2013
Date registered
5/04/2013
Date last updated
22/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Road to Recovery: Low intensity, early intervention for pain and trauma following motor vehicle accidents
Scientific title
Road to Recovery: Low intensity, early intervention for pain and trauma following motor vehicle accidents
Secondary ID [1] 282014 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 288455 0
Post Traumatic Stress 288456 0
Condition category
Condition code
Injuries and Accidents 288800 288800 0 0
Other injuries and accidents
Mental Health 288801 288801 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low intensity Cognitive Behavioural Therapy (CBT) based information package, administered on-line. Information package will be provided to participants to enhance their understanding of chronic pain and post traumatic stress. Information about useful strategies and helpful skills to cope with pain / post traumatic stress symptoms will also be provided, as well as evidence based treatment options, and the participants can decide whether to utilise the information provided.The duration of the study is 6 months and the participants are free to access the information package anytime at their discretion.
Intervention code [1] 286585 0
Prevention
Intervention code [2] 286586 0
Rehabilitation
Intervention code [3] 286587 0
Behaviour
Comparator / control treatment
Waitlist control - Intervention will be offered 6 months following the initial survey
Control group
Active

Outcomes
Primary outcome [1] 288938 0
Primary Outcome 1- Chronic Pain
Regional Pain Scale
Modified Von Korff Scale
Modified Roland- Morris Disability Questionnaire
Timepoint [1] 288938 0
At 3 months and 6 months post initial survey
Primary outcome [2] 288939 0
Primary Outcome 2- Anxiety
Generalised Anxiety Disorder Quesionnaire
PTSD Checklist
Telephone interview - MINI PTSD module
Timepoint [2] 288939 0
3 months and 6 months post initial survey.
Secondary outcome [1] 301393 0
General Wellbeing assessed by:
Patient Health Questionnaire - 9 (PHQ9),
SF-12
Health and Medication use
Activity and Participation Questionnaire-6 (APQ6)
Timepoint [1] 301393 0
3 and 6 months post initial survey for all exept APQ6.
6 months post initial survey for APQ6.
Secondary outcome [2] 301394 0
Patient Global Impression of change
Timepoint [2] 301394 0
3 & 6 months post initial survey

Eligibility
Key inclusion criteria
Experience of Motor Vehicle accidents within the previous month, aged between 18-65, reside within NSW, having access to the internet
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Very severe depression (score on PHQ-9 of 22 or over) or poorly or uncontrolled psychotic disorder.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will complete an on-line survey at the onset of the study. At the end of the survey, they will be randomised into the 2 conditions through central randomisation by the survey website.Therefore, allocation will be concealed from the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An HTML code in the on-line survey website will automatically allow randomisation for those who complete the survey.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286788 0
Government body
Name [1] 286788 0
Motor Accidents Authority of NSW
Country [1] 286788 0
Australia
Primary sponsor type
Individual
Name
Dr. Kathryn Nicholson Perry
Address
Centre for Health Research / School of Social Sciences and Psychology
University of Western Sydney
Locked Bag 1797
Penrith South
NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 285649 0
Individual
Name [1] 285649 0
Associate Professor Federico Girosi
Address [1] 285649 0
School of Medicine, Centre for Health Research
Campbelltown Campus, Bldg. 3
Locked Bag 1797
Penrith NSW 2791
Country [1] 285649 0
Australia
Secondary sponsor category [2] 285650 0
Individual
Name [2] 285650 0
Dr Blake Dear
Address [2] 285650 0
Centre for Emotional Health (CEH)
Department of Psychology
Macquarie University
North Ryde NSW 2109
Country [2] 285650 0
Australia
Secondary sponsor category [3] 285651 0
Individual
Name [3] 285651 0
Professor Michael Nicholas
Address [3] 285651 0
Pain Management and Research Institute
Royal North Shore Hospital
St Leonards NSW 2065
Country [3] 285651 0
Australia
Secondary sponsor category [4] 285652 0
Individual
Name [4] 285652 0
Associate Professor Fiona Blyth
Address [4] 285652 0
Department of Medicine,
1st Floor, Clinical Sciences Building,
Concord Hospital, Hospital Road,
Concord NSW 2139
Country [4] 285652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288855 0
University of Western Sydney Human Research ethics Committee
Ethics committee address [1] 288855 0
Ethics committee country [1] 288855 0
Australia
Date submitted for ethics approval [1] 288855 0
Approval date [1] 288855 0
28/11/2012
Ethics approval number [1] 288855 0
H9954

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38078 0
Dr Kathryn Nicholson Perry
Address 38078 0
Centre for Health Research / School of Social Sciences and Psychology
University of Western Sydney
Locked Bag 1797
Penrith South
NSW 2751
Country 38078 0
Australia
Phone 38078 0
+61297726781
Fax 38078 0
Email 38078 0
[email protected]
Contact person for public queries
Name 38079 0
Kathryn Nicholson Perry
Address 38079 0
Centre for Health Research / School of Social Sciences and Psychology
University of Western Sydney
Locked Bag 1797
Penrith South
NSW 2751
Country 38079 0
Australia
Phone 38079 0
+61297726781
Fax 38079 0
Email 38079 0
[email protected]
Contact person for scientific queries
Name 38080 0
Kathryn Nicholson Perry
Address 38080 0
Centre for Health Research / School of Social Sciences and Psychology
University of Western Sydney
Locked Bag 1797
Penrith South
NSW 2751
Country 38080 0
Australia
Phone 38080 0
+61297726781
Fax 38080 0
Email 38080 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.