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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 7 June 2021
Main ID:  ACTRN12616001445460
Date of registration: 17/10/2016
Prospective Registration: Yes
Primary sponsor: Professor Ashley Craig
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.
Date of first enrolment: 16/06/2017
Target sample size: 240
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616001445460.aspx
Study type:  Observational
Study design:  Purpose: Psychosocial;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Dr 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 Australia
Telephone: +61 2 9926 4962
Email: ilaria.pozzato@sydney.edu.au
Affiliation: 
Name: Dr 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 Australia
Telephone: +61 2 9926 4962
Email: ilaria.pozzato@sydney.edu.au
Affiliation: 
Key inclusion & exclusion criteria
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.


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.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Musculoskeletal - Other muscular and skeletal disorders
Psychological distress associated with physical injuries sustained in a motor vehicle crash (MVC).;Stress-related physical conditions associated with injuries due to MVC.;
Psychological distress associated with physical injuries sustained in a motor vehicle crash (MVC).
Stress-related physical conditions associated with injuries due to MVC.
Injuries and Accidents - Other injuries and accidents
Mental Health - Other mental health disorders
Intervention(s)
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.
Primary Outcome(s)
Probable PTSD, as assessed by the Impact of Event Scale (IES).[1, 3, 6, 12 months post-crash]
Depressed mood and elevated anxiety, as assessed by the Depression, Anxiety and Stress Scale (DASS21).[1, 3, 6, 12 months post-crash]
Autonomic functioning as assessed by heart rate, heart rate variability, respiration rate, and associated physiological measures.[1, 3, 6, 12 months post-crash]
Secondary Outcome(s)
Resilience as assessed by a 10-point Likert scale and self-reported questions on coping strategies.[1, 3, 6, 12 months post-crash]
Mental and physical health-related quality of life as assessed by SF12.[1, 3, 6, 12 months post-crash]
Social Participation as assessed by Disability and functioning (WHODAS II) - Domain 6.[1, 3, 6, 12 months post-crash]
Driving phobia, as assessed by diagnostic interview using DSM V criteria.[1, 3, 6, 12 months post-crash]
Emotional functioning as assessed by Positive and Negative Affect Schedule (PANAS).[1, 3, 6, 12 months post-crash]
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.[1, 3, 6, 12 months post-crash]
Adjustment Disorder, as assessed by diagnostic interview using DSM V criteria.[1, 3, 6, 12 months post-crash]
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.[1, 3, 6, 12 months post-crash]
Cognitive/Intellectual functioning as assessed by Disability and functioning (WHODAS II) - Domain 1.[1, 3, 6, 12 months post-crash]
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.[1, 3, 6, 12 months post-crash]
Secondary ID(s)
NIL
Source(s) of Monetary Support
State Insurance Regulatory Authority of NSW
Secondary Sponsor(s)
Dr Ilaria Pozzato (PhD student undertaking this project as a PhD project)
Ethics review
Status: Approved
Approval date: 26/04/2016
Contact:
Sydney Local Health District Human Research Ethics Committee
Results
Results available: Yes
Date Posted: 20/11/2019
Date Completed: 31/03/2020
URL:
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