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Trial registered on ANZCTR


Registration number
ACTRN12616001445460
Ethics application status
Approved
Date submitted
4/10/2016
Date registered
17/10/2016
Date last updated
20/11/2019
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of psychological distress on recovery from injuries sustained in a traffic crash. (The IMPRINT Study).
Scientific title
Predictors and biomarkers of psychological distress following a traffic injury: a prospective cohort study.
Secondary ID [1] 290258 0
NIL
Universal Trial Number (UTN)
U1111-1188-2502
Trial acronym
The IMPRINT Study.
Linked study record
The FISH Study - Trial ID: ACTRN12613000889752.

Health condition
Health condition(s) or problem(s) studied:
Psychological distress associated with physical injuries sustained in a motor vehicle crash (MVC). 300475 0
Stress-related physical conditions associated with injuries due to MVC. 300476 0
Condition category
Condition code
Injuries and Accidents 300332 300332 0 0
Other injuries and accidents
Mental Health 300333 300333 0 0
Other mental health disorders
Musculoskeletal 300449 300449 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Development of psychological distress and morbidity (and associated stress-related symptoms and co-occurring diseases) will be prospectively studied over 1 year, in adults (18 years and above) who have sustained minor to moderate injury in a MVC in New South Wales, Australia. Participants will be followed up at 1 (6 weeks), 3, 6 and 12 months.
Intervention code [1] 296051 0
Not applicable
Comparator / control treatment
The control group for this study is a healthy control group, who have not experienced a MVC in the past 5 years and who will be undergoing the same assessments as MVC survivors.
Healthy volunteers can participate only as non-MVC controls. The healthy controls will be recruited on a convenience basis to allow for comparison. They will be matched for age (+/- 5 years), sex and education to the injured participants on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 299879 0
Depressed mood and elevated anxiety, as assessed by the Depression, Anxiety and Stress Scale (DASS21).
Timepoint [1] 299879 0
1, 3, 6, 12 months post-crash
Primary outcome [2] 299880 0
Probable PTSD, as assessed by the Impact of Event Scale (IES).
Timepoint [2] 299880 0
1, 3, 6, 12 months post-crash
Primary outcome [3] 299881 0
Autonomic functioning as assessed by heart rate, heart rate variability, respiration rate, and associated physiological measures.
Timepoint [3] 299881 0
1, 3, 6, 12 months post-crash
Secondary outcome [1] 328159 0
Stress-related physical conditions, as assessed by pain numeric pain scale (NRS), visual analogue fatigue scale (VAFS) and self-reported questions about physical symptoms/clinical diagnoses since the accident.
Timepoint [1] 328159 0
1, 3, 6, 12 months post-crash
Secondary outcome [2] 328160 0
Mental and physical health-related quality of life as assessed by SF12.
Timepoint [2] 328160 0
1, 3, 6, 12 months post-crash
Secondary outcome [3] 328161 0
Social Participation as assessed by Disability and functioning (WHODAS II) - Domain 6.
Timepoint [3] 328161 0
1, 3, 6, 12 months post-crash
Secondary outcome [4] 328162 0
Return to work, as assessed by self-reported questions on work history, return to work, duties modification, job satisfaction, and expectations to return to work.
Timepoint [4] 328162 0
1, 3, 6, 12 months post-crash
Secondary outcome [5] 328163 0
Return to usual activities (excluding work), as assessed by self-reported questions on return to usual activities and expectations to return to pre-crash activities.
Timepoint [5] 328163 0
1, 3, 6, 12 months post-crash
Secondary outcome [6] 328164 0
Resilience as assessed by a 10-point Likert scale and self-reported questions on coping strategies.
Timepoint [6] 328164 0
1, 3, 6, 12 months post-crash
Secondary outcome [7] 328165 0
Cognitive/Intellectual functioning as assessed by Disability and functioning (WHODAS II) - Domain 1.
Timepoint [7] 328165 0
1, 3, 6, 12 months post-crash
Secondary outcome [8] 328166 0
Emotional functioning as assessed by Positive and Negative Affect Schedule (PANAS).
Timepoint [8] 328166 0
1, 3, 6, 12 months post-crash
Secondary outcome [9] 328167 0
Driving phobia, as assessed by diagnostic interview using DSM V criteria.
Timepoint [9] 328167 0
1, 3, 6, 12 months post-crash
Secondary outcome [10] 328380 0
Adjustment Disorder, as assessed by diagnostic interview using DSM V criteria.
Timepoint [10] 328380 0
1, 3, 6, 12 months post-crash

Eligibility
Key inclusion criteria
The inclusion criteria for participants are as follows::
1. Age 18 years and above.
2. Recently sustained (in last 28 days) a minor to moderate injury due to motor vehicle crash in NSW.
3. A motor vehicle driver, motorbike rider, passenger, pillion passengers, pedestrians and bicyclists (only collision involving a motorised vehicle in a traffic accident).
4. Admitted to ED departments in NSW with a valid Medicare number.
5. English speaking.

The inclusion criteria for the control group are as follows:
1. 18 years of age or older
2. no history of injury or experience of a MVC in the previous five years.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Catastrophic injuries as defined by the Lifetime Care and Support Authority (NSW). These include severe traumatic brain injury, spinal cord injury, extensive burns to the body (over 60%), amputations and blindness.
2. Localised, superficial soft tissue injuries.
3. Death of an immediate family member in the land transport crash.
4. MVC due to intentional self –harm.
5. Dementia or pre-existing cognitive impairment affecting ability to consent.
6. Non-English speaking with insufficient English language competence.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Proposed recruitment for the study is approximately 100 MVC participants. This cohort will be compared to a group of 100 non-MCV controls. Allowing for 20-30% loss to follow-up, it is anticipated that a minimum sample size of around 40 people per group is required to achieve a statistical power of 80%, assuming an effect size of only 0.3 (at a=0.05, 2 groups, using a repeated measures MANOVA).

Descriptive analysis will be performed for socio-demographic data and other variables of interest to describe the sample study. To identify important biomarkers and predictors of psychological distress at 12 months post MVC, Bivariate and multivariate regression analyses will be performed for each outcome of interest, adjusted for potential confounding factors. Also, subgroup analysis using multivariable linear and logistic regression will be performed to established differences in outcomes.

Recruitment
Recruitment status
Active, not recruiting
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)
NSW
Recruitment hospital [1] 6761 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 6762 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 14407 0
2050 - Camperdown
Recruitment postcode(s) [2] 14408 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 294626 0
Government body
Name [1] 294626 0
State Insurance Regulatory Authority of NSW
Address [1] 294626 0
Level 25, 580 George Street, Sydney, NSW 2000
Country [1] 294626 0
Australia
Primary sponsor type
Individual
Name
Professor Ashley Craig
Address
John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, St Leonards, NSW 2065.
Country
Australia
Secondary sponsor category [1] 293490 0
Individual
Name [1] 293490 0
Dr Ilaria Pozzato (PhD student undertaking this project as a PhD project)
Address [1] 293490 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, St Leonards, NSW 2065.
Country [1] 293490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296066 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 296066 0
Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Ethics committee country [1] 296066 0
Australia
Date submitted for ethics approval [1] 296066 0
25/08/2015
Approval date [1] 296066 0
26/04/2016
Ethics approval number [1] 296066 0
HREC/15/RPAH/423

Summary
Brief summary
Rationale: The biological mechanisms leading to psychological disorders and morbidity after MVC remain unclear. There is now solid evidence that aberrant heartbeats are a sign of poor adaptability to stressful events, and this relates to an unbalanced state of the autonomic nervous system (ANS). However, the significance of heart activity to identify who is more likely to develop a psychological distress and to fail to recover from traumatic injury is not yet well understood. The proposed study will address this important gap in research by using heart activity as a promising biomarker in early recognition of psychological sequelae and stress-related morbidity after a MVC. The use of a biopsychosocial model will shed light on possible links to autonomic responses and risks factors identified in the literature as key contributors to recovery following a MVC.
Aims: (1) To determine whether heart activity predicts vulnerability to psychopathological conditions (e.g. depression, PTSD, etc) and associated morbidity (eg pain, fatigue, etc) following a MVC. (2) To compare psychophysiological status and morbidity to a group of non-MVC controls. (3) To determine the strength of relationship between ANS activation (heart activity) and key risk factors implicated in recovery after MVC, with an emphasis on emotional and cognitive responses to the crash.
Method: The study will utilise a prospective, case-control cohort design. Participants will be adults, who have experienced a minor to moderate injury after a MVC and subsequently admitted to an ED of major hospitals in NSW. Proposed recruitment is approximately 70 to 100 MVC survivors. Comparisons to a healthy control group (who have not experienced a MVC in the past 5 years), age-sex matched to MVC survivors, will also occur. The design will involve longitudinal assessment, with follow-up measures at 3, 6 and 12 months post-injury, after the baseline (within 6 weeks of the MVC). MVC survivors and controls will be similarly assessed. (a) Autonomic assessment: The assessment of ANS will consist of collection of early post-crash vital signs (at the scene and Emergency Department admission), as well as prospective ECG-based HRV recordings, performed at baseline and 3 months post-injury. (b) Biopsychosocial assessment: The autonomic response to the MVC will be investigated over time in relation to personal and environmental factors, known as influencing health outcome and recovery after an injury. This data, together with health and social outcomes, will be collected using online interviewing assessment at baseline, 3, 6 and 12 months post-injury.
Significance: Key outcomes are psychological distress, stress-related physical conditions and recovery indicators over a 12 month period after a MVC. Findings will clarify whether biomarkers of psychological distress exist and can aid in identifying the most vulnerable people, avoiding delay in recovery and return to work, decreasing costs, and preventing chronicity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69138 0
Prof Ashley Craig
Address 69138 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, St Leonards, NSW 2065
Country 69138 0
Australia
Phone 69138 0
+61 2 9809 4925
Fax 69138 0
+61 2 9926 4045
Email 69138 0
ashleycraig@med.usyd.edu.au
Contact person for public queries
Name 69139 0
Dr Ilaria Pozzato
Address 69139 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, St Leonards, NSW 2065
Country 69139 0
Australia
Phone 69139 0
+61 2 9926 4962
Fax 69139 0
+61 2 9926 4045
Email 69139 0
ilaria.pozzato@sydney.edu.au
Contact person for scientific queries
Name 69140 0
Dr Ilaria Pozzato
Address 69140 0
John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute of Medical Research, Corner Reserve Road & First Avenue, St Leonards, NSW 2065
Country 69140 0
Australia
Phone 69140 0
+61 2 9926 4962
Fax 69140 0
+61 2 9926 4045
Email 69140 0
ilaria.pozzato@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
subject to doctoral study
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 5777 0
Study protocol
Citation [1] 5777 0
Pozzato, I., Craig, A., Gopinath, B., Tran, Y., Dinh, M., Gillett, M., & Cameron, I. (2019). Biomarkers of autonomic regulation for predicting psychological distress and functional recovery following road traffic injuries: protocol for a prospective cohort study. BMJ open, 9(4), e024391.
Link [1] 5777 0
Email [1] 5777 0
Other [1] 5777 0
Attachment [1] 5777 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary