ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000170325

Ethics application status

Approved

Date submitted

21/01/2026

Date registered

10/02/2026

Date last updated

10/02/2026

Date data sharing statement initially provided

10/02/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Changing Anxiety Response with Emotional Support (CARES)

Scientific title

Investigating the impact of psychosocial intervention for patients reporting anxiety in hospital following a traumatic injury on 6 month reported anxiety levels (compared to a retrospective cohort)

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

CARES

Related trial records

Health condition

Health condition(s) studied:

Anxiety

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Study participants will receive an intervention phone call from a Social Worker or Clinical Psychologist within 5-7 days of completing the screening tools [EuroQOL 5 Dmension 5 Level((EQ5D-5L), Primary Care PTSD screen for DSM-5 (PC-PTSD-5), Kessler 10 (K10) and Multidimensional Scale of Perceived Social Support )MSPSS)] in order to triage the participant for social work or psychology intervention and undertake initial goal setting. If scores indicate high distress, the research assistant or project lead will alert the Social worker (SW) and/or psychologist for priority call for risk assessment and treatment as indicated.
The appropriate clinician and interventions to be delivered will be identified based on the results from the questionnaires. Social Work interventions include assessment and interventions related to housing/financial/legal issues, social supports, or emotional support. Clinical Psychology interventions include psychosocial support with focus on psychoeducation, psychological first aid, trauma informed emotional support and coping strategies. Both interventions will provide the patient with personalised resources, dependent on patient needs eg information regarding child support, family violence, Lifeline etc. The sessions will take place via phone call unless the patient has a strong desire for face to face meetings which could be facilitated. Depending upon the levels of distress and/or concerns raised by the participants in both response to the questionnaires and/ in the phone contact, psychology and/social work interventions will be provided as deemed clinically necessary. Community referrals will be facilitated as required, and duration and frequency of sessions will be considered in line with psychology and social work professional duty of care standards, hence the total duration is unknown but we anticipate that the follow up will be less than 2 months. Session completion records including length and number of treatments will be recorded.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Description of the comparator or control

Retrospective control group - Patients admitted to the Alfred Hospital trauma ward (5 West) who reported greater than moderate on the EQ5D-5L in the two years prior to study commencement (January 01 2023 to Dec 31 2024). These patients did not receive follow up phone care or intervention.

Control group

Historical

Outcomes

Primary outcome [1]

The primary outcome is distress levels on EuroQol-5Dimension 5 Levels of severity (EQ5D-5L) at 6 months comparing participants in the intervention group with a similar cohort in the baseline group. We will account for any confounding factors e.g., pre-morbid anxiety levels using regression analysis.

Timepoint [1]

6 months following injury

Secondary outcome [1]

Secondary outcome is Return to work (for those working prior to injury) at 6 months comparing participants in the intervention group with a similar cohort in the baseline group. We will account for any confounding factors e.g., pre-morbid anxiety levels using regression analysis.

Timepoint [1]

6 months following injury which lead to hospitalisation

Secondary outcome [2]

Secondary outcome is quality of life (for those working prior to injury) at 6 months comparing participants in the intervention group with a similar cohort in the baseline group. We will account for any confounding factors e.g., pre-morbid anxiety levels using regression analysis.

Timepoint [2]

6 months following injury which lead to hospitalisation

Secondary outcome [3]

Secondary outcome is residential status (for those working prior to injury) at 6 months comparing participants in the intervention group with a similar cohort in the baseline group. We will account for any confounding factors e.g., pre-morbid anxiety levels using regression analysis.

Timepoint [3]

6 months following hospitalisation

Secondary outcome [4]

secondary outcome is patent function and pain at 6 months comparing participants in the intervention group with a similar cohort in the baseline group. This is collected by registry data - registry based outcome (VOTOR or VSTR). We will account for any confounding factors e.g., pre-morbid anxiety levels using regression analysis.

Timepoint [4]

6 months following injury resulting in hospitalisation

Eligibility

Key inclusion criteria

All patients admitted to the trauma unit at The Alfred between 1/2/2026 to 31/1/2027 who meet study eligibility criteria will be approached regarding study inclusion:
Inclusion criteria
- Age 18 years or older
- Admitted to The Alfred trauma ward following a traumatic incident
- Able to provide written informed consent
- EQ-5D is a routinely administered questionnaire as part of usual care: threshold for study inclusion is an anxiety/depression score =moderate on hospital admission or discharge (approximately 250 patients/year)
- Valid Medicare card

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

discharge destination is prison
unable to consent for themselves

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Use of historical cohort as previously described

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/02/2026

Actual

Date of last participant enrolment

Anticipated

12/02/2027

Actual

Date of last data collection

Anticipated

27/08/2027

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Transport Accident Commission

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Transport Accident Commission

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2025

Approval date [1]

07/01/2026

Ethics approval number [1]

Summary

Brief summary

Mental health disorders are seen in up to 30-50% of people involved in traffic accidents. Post-traumatic stress disorder (PTSD) and depression are common mental health disorders experienced by survivors of traumatic incidents and are predictive of poor recovery. Research suggests that providing psychosocial rehabilitation programs and early intervention/identification is paramount.
This study will involve providing Social work and psychology input to patients who report anxiety following a traumatic injury.  This will occur at 4-6 weeks post acute hospital discharge.  The outcome will be their self reported anxiety/distress at 6 months post injury.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lara Kimmel

Address

Bayside Health: Alfred Care Group. 55 Commercial Rd, Melbourne, Victoria. 3004

Country

Australia

Phone

+61 419501387

Fax

[email protected]

Contact person for public queries

Name

Lara Kimmel

Address

Bayside Health: Alfred Care Group. 55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 419501387

Fax

[email protected]

Contact person for scientific queries

Name

Lara Kimmel

Address

Bayside Health: Alfred Care Group. 55 Commercial Rd, Melbourne, Victoria. 3004

Country

Australia

Phone

+61 419501387

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					122457 (Local Reference 697-25) Ethics Approval 07-Jan-2026.pdf

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.

Trial Review

Documents added manually

Documents added automatically