ANZCTR - Registration

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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

31/05/2021

Date data sharing statement initially provided

14/11/2018

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]

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).

Stress-related physical conditions associated with injuries due to MVC.

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Mental Health

Other mental health disorders

Musculoskeletal

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]

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]

Depressed mood and elevated anxiety, as assessed by the Depression, Anxiety and Stress Scale (DASS21).

Timepoint [1]

1, 3, 6, 12 months post-crash

Primary outcome [2]

Probable PTSD, as assessed by the Impact of Event Scale (IES).

Timepoint [2]

1, 3, 6, 12 months post-crash

Primary outcome [3]

Autonomic functioning as assessed by heart rate, heart rate variability, respiration rate, and associated physiological measures.

Timepoint [3]

1, 3, 6, 12 months post-crash

Secondary outcome [1]

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]

1, 3, 6, 12 months post-crash

Secondary outcome [2]

Mental and physical health-related quality of life as assessed by SF12.

Timepoint [2]

1, 3, 6, 12 months post-crash

Secondary outcome [3]

Social Participation as assessed by Disability and functioning (WHODAS II) - Domain 6.

Timepoint [3]

1, 3, 6, 12 months post-crash

Secondary outcome [4]

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]

1, 3, 6, 12 months post-crash

Secondary outcome [5]

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]

1, 3, 6, 12 months post-crash

Secondary outcome [6]

Resilience as assessed by a 10-point Likert scale and self-reported questions on coping strategies.

Timepoint [6]

1, 3, 6, 12 months post-crash

Secondary outcome [7]

Cognitive/Intellectual functioning as assessed by Disability and functioning (WHODAS II) - Domain 1.

Timepoint [7]

1, 3, 6, 12 months post-crash

Secondary outcome [8]

Emotional functioning as assessed by Positive and Negative Affect Schedule (PANAS).

Timepoint [8]

1, 3, 6, 12 months post-crash

Secondary outcome [9]

Driving phobia, as assessed by diagnostic interview using DSM V criteria.

Timepoint [9]

1, 3, 6, 12 months post-crash

Secondary outcome [10]

Adjustment Disorder, as assessed by diagnostic interview using DSM V criteria.

Timepoint [10]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

31/10/2016

Actual

16/06/2017

Date of last participant enrolment

Anticipated

31/01/2019

Actual

29/03/2019

Date of last data collection

Anticipated

31/03/2020

Actual

31/03/2020

Sample size

Target

240

Accrual to date

Final

232

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

State Insurance Regulatory Authority of NSW

Address [1]

Level 25, 580 George Street, Sydney, NSW 2000

Country [1]

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]

Individual

Name [1]

Dr Ilaria Pozzato (PhD student undertaking this project as a PhD project)

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2015

Approval date [1]

26/04/2016

Ethics approval number [1]

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

Prof 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

Phone

+61 2 9809 4925

Fax

+61 2 9926 4045

ashleycraig@med.usyd.edu.au

Contact person for public queries

Name

Ilaria Pozzato

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

Phone

+61 2 9926 4962

Fax

+61 2 9926 4045

ilaria.pozzato@sydney.edu.au

Contact person for scientific queries

Name

Ilaria Pozzato

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

Phone

+61 2 9926 4962

Fax

+61 2 9926 4045

ilaria.pozzato@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

subject to doctoral study

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5777	Study protocol	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.

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The importance of self-regulation and mental health for effective recovery after traffic injuries: A comprehensive network analysis approach.	2024	https://dx.doi.org/10.1016/j.jpsychores.2023.111560

N.B. These documents automatically identified may not have been verified by the study sponsor.

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