Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000326594
Ethics application status
Approved
Date submitted
7/03/2015
Date registered
9/04/2015
Date last updated
26/07/2019
Date data sharing statement initially provided
26/07/2019
Date results information initially provided
26/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing psychological distress following a motor vehicle crash
Scientific title
Preventing psychological distress following a motor vehicle crash: evaluating the efficacy of brief psychological and lifestyle interventions for preventing severe psychological injury in adults who have experienced a motor vehicle crash
Secondary ID [1] 286328 0
Nil
Universal Trial Number (UTN)
U1111-1167-9950
Trial acronym
MAAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor vehicle accident 294434 0
Anxiety and depressive disorder 294548 0
Condition category
Condition code
Injuries and Accidents 294740 294740 0 0
Other injuries and accidents
Mental Health 294855 294855 0 0
Anxiety
Mental Health 294856 294856 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief cognitive behaviour therapy including strategies like self-monitoring of mood and anxiety, slow breathing, problem solving, pleasant life events and mindfulness. Five sessions of around 60 minutes, administered by a psychologist, will be emailed to participants every 2nd week over 10 weeks. Participants will be contacted by a psychologist via a telephone call, every week for the 10 weeks, for up to 30 minutes to discuss application of skills and to improve adherence.
2. Healthy lifestyle intervention including self-monitoring of behaviours like diet intake and exercise; goal setting, education on healthy sleep behaviour, education on healthy exercise behaviour and diet. Five sessions of around 60 minutes, administered by a psychologist, will be emailed to participants every 2nd week over 10 weeks. Participants will be contacted by a psychologist via a telephone call every week for the 10 weeks, for up to 30 minutes to discuss application of skills and to improve adherence.
The participants will be randomised to either one of the two interventions or the control condition, so that one-third will receive the brief CBT, one-third the healthy lifestyle and one-third the control condition.
Intervention code [1] 291375 0
Behaviour
Intervention code [2] 291376 0
Prevention
Intervention code [3] 291377 0
Lifestyle
Comparator / control treatment
A psychologist will contact by telephone for up to 30 minutes every week for 10 weeks to discuss how they are going and how their claim is proceeding. There will be no psychological or healthy lifestyle advice given. New reading material on compensation and injury factors following a road accident will be sent by email every 2 weeks for 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294501 0
depressive mood assessed by DASS and DSM 5 symptoms of major depressive disorder
Timepoint [1] 294501 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.
Primary outcome [2] 294502 0
quality of life assessed by SF 12
Timepoint [2] 294502 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.
Primary outcome [3] 294503 0
anxiety levels assessed by the Impact of Events Scale and DSM 5 symptoms of PTSD, Panic Disorder and Adjustment Disorder
Timepoint [3] 294503 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.
Secondary outcome [1] 313467 0
self-efficacy assessed by General Self-Efficacy Scale
Timepoint [1] 313467 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.
Secondary outcome [2] 313468 0
pain catastrophisation assessed by the Pain Catastrophisation Scale
Timepoint [2] 313468 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.
Secondary outcome [3] 313469 0
Resilience assessed by the Connor Davidson Resilience Scale
Timepoint [3] 313469 0
Within 4-8 weeks of the motor vehicle crash, and around 3 and 6 months post motor vehicle crash, and 12-18 month follow-up now included.

Eligibility
Key inclusion criteria
(i) adults; (ii) recently experienced a motor vehicle crash; (iii) CTP member; (iv) English speaking; (v) must have experienced a motor vehicle crash within the past 4-8 weeks
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
very severe injury such as acute spinal cord injury or severe traumatic brain injury

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)
Potential participants will be recruited after they have had a motor vehicle crash and they have rung Suncorp or NRMA in NSW, or Transport Accident Commission in Victoria, for CTP cover. The potential participant will be advised that a study is being conducted by the University of Sydney on preventing psychological distress associated with a motor vehicle crash. If the person is interested, a researcher will contact and discuss their willingness to participate. The Participant information and Consent forms will then be sent if the person agrees. Their name will then be given to the database manager who will randomise to one of three study arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator (randomisation table) will be used to allocate participants to the study arms.
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
Based on prior results of CBT and healthy lifestyle interventions, the two interventions are assumed to have a moderate mean effect size of around 0.5. Therefore, 180 participants (60 in each arm) should provide at least 80% statistical power to detect a true outcome. Statistics to determine efficacy of the interventions will include MANCOVA with protected t-tests with comparisons to the control arm

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
30/07/2015
Date of last participant enrolment
Anticipated
15/12/2016
Actual
4/12/2017
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
180
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 9350 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 290897 0
Government body
Name [1] 290897 0
Motor Accident Authority of NSW
Country [1] 290897 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 289577 0
Commercial sector/Industry
Name [1] 289577 0
Suncorp Insurance
Address [1] 289577 0
GPO Box 112

Suncorp Place

18 Jamison Street, Sydney NSW 2000
Country [1] 289577 0
Australia
Secondary sponsor category [2] 303433 0
Commercial sector/Industry
Name [2] 303433 0
NRMA
Address [2] 303433 0
Tower Two, Darling Park, 201 Sussex St Sydney, NSW, 2000
Country [2] 303433 0
Australia
Secondary sponsor category [3] 303434 0
Government body
Name [3] 303434 0
Transport Accident Commission
Address [3] 303434 0
60 Brougham St, Geelong, Victoria, 3220
Country [3] 303434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292499 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292499 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 292499 0
Date submitted for ethics approval [1] 292499 0
Approval date [1] 292499 0
26/02/2015
Ethics approval number [1] 292499 0
2015/016

Summary
Brief summary
Psychological injury is a common outcome following a motor vehicle crash (MVC) and the claims process can result in further deterioration of mental, social and physical health. The provision of brief psychological or healthy lifestyle interventions soon after people who have experienced an MVC and who engage in the compensation scheme should improve wellbeing by reducing risks of psychological and physical distress. Improved wellbeing should also result in reduced scheme costs, for instance, by preventing the development of severe psychological injury and enhancing return to normal daily functioning. This Project will investigate the efficacy, using a randomised control trial design, of two email-delivered interventions designed to improve and maintain physical health and strengthen mental health. It is hypothesised that participants receiving one of the two brief interventions will exhibit less psychological distress compared to control particpants 6 months after the road accident.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 344 344 0 0
/AnzctrAttachments/368141-psych injury brief intervention ethics approval.pdf

Contacts
Principal investigator
Name 55622 0
Prof Ashley Craig
Address 55622 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, Faculty of Medicine and Health, THE UNIVERSITY OF SYDNEY.
Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, Royal North Shore Hospital, St Leonards, NSW 2065
Country 55622 0
Australia
Phone 55622 0
+61 2 99264962
Fax 55622 0
+61 2 9926 4045
Email 55622 0
[email protected]
Contact person for public queries
Name 55623 0
Ms Rebecca Guest
Address 55623 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, Faculty of Medicine and Health, THE UNIVERSITY OF SYDNEY.
Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, Royal North Shore Hospital, St Leonards, NSW 2065
Country 55623 0
Australia
Phone 55623 0
+61 2 99264962
Fax 55623 0
+61 2 9926 4045
Email 55623 0
[email protected]
Contact person for scientific queries
Name 55624 0
Dr Yvonne Tran
Address 55624 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, Faculty of Medicine and Health, THE UNIVERSITY OF SYDNEY.
Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, Royal North Shore Hospital, St Leonards, NSW 2065
Country 55624 0
Australia
Phone 55624 0
+61 2 99264962
Fax 55624 0
+61 2 9926 4045
Email 55624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not at present due to confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrevention of the development of psychological distress following a motor vehicle crash: Study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1455-5
EmbasePrevalence and psychometric screening for the detection of major depressive disorder and post-traumatic stress disorder in adults injured in a motor vehicle crash who are engaged in compensation.2018https://dx.doi.org/10.1186/s40359-018-0216-5
EmbasePsychological distress following a motor vehicle crash: Preliminary results of a randomised controlled trial investigating brief psychological interventions.2018https://dx.doi.org/10.1186/s13063-018-2716-2
N.B. These documents automatically identified may not have been verified by the study sponsor.