ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625001380482

Ethics application status

Approved

Date submitted

5/11/2025

Date registered

9/12/2025

Date last updated

5/06/2026

Date data sharing statement initially provided

9/12/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Treating first responder’s trauma symptoms following a recent critical incident: A Randomised Controlled Trial of Eye Movement Desensitisation and Reprocessing Protocol for Recent Critical Incidents (EMDR-PRECI) compared with Psychosocial Skills Training

Scientific title

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Post-traumatic stress symptoms

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

In this clinical trial we will test the effectiveness of EMDR as an early intervention to reduce posttraumatic stress for Ambulance Victoria first responders. We will compare the effectiveness of EMDR Protocol for Recent Critical Incidents (EMDR-PRECI) to an active control group who will receive Psychosocial Skills Training (PST), an intervention that does not directly target the trauma memory.
The intervention arm of the study will use the EMDR Protocol for Recent Critical Incidents and Ongoing Traumatic Stress (EMDR-PRECI) for In-person or Online Administration developed by Ignacio Jarero and Lucina Artigas (1998-2022). Treatment involves participants focusing on disturbing parts of the recent critical incident while simultaneously engaging in a bilateral task (i.e., as eye movements for in-person sessions and tapping for online sessions) with the aim of reducing the vividness and negative emotions associated with trauma memories. This process is repeated until all disturbing parts of the memory have been reprocessed and associated subjective distress has reduced to 0 (or ecological validity). Treatment also includes the installation of a positive belief relating to the critical incident and a body scan, again while executing the bilateral task. The treatment is manualised and will be delivered by Ambulance Victoria experienced psychologists either in-person or online.
The intervention will consist of up to six individual sessions lasting for 60 minutes. Massed treatment, i.e., the provision of multiple therapy sessions in a short period of time, will consist of 2 sessions per week delivered over a three-week period and provided by rotating clinicians. A sample of the recorded sessions will be reviewed by two independent reviewers for treatment fidelity adherence and quality assurance.

Intervention code [1]

Treatment: Other

Description of the comparator or control

The Psychosocial Skills Training that makes up the active control of the study has been developed internally by senior members of the AV Psychology team utilising a ‘third wave’ cognitive behavioural framework and integrates core interventions frequently used in evidence-based psychological treatment such as Cognitive Behavioural Therapy, Acceptance and Commitment Therapy and Dialectical Behaviour Therapy. It consists of six modules: grounding and distress tolerance techniques; psychoeducation and tips relating to sleep, behavioural activation, exercise and nutrition; challenging unhelpful thoughts and problem-solving skills; clarifying values and reviewing behavioural activation; assertiveness skills with a compassion focus and; reviewing content and planning to practise skills. Materials to reinforce learning and practising of skills - such as information sheets, practice handouts, skills scripts, and short video clips - will be shared with participants. The treatment is manualised and will be delivered by Ambulance Victoria experienced psychologists either in-person or online.
Treatment will consist of up to six individual sessions lasting for 60 minutes. Massed treatment, i.e., the provision of multiple therapy sessions in a short period of time, will consist of 2 sessions per week delivered over a three-week period and provided by rotating clinicians. A sample of the recorded sessions will be reviewed by two independent reviewers for treatment fidelity adherence and quality assurance.

Control group

Active

Outcomes

Primary outcome [1]

Severity of posttraumatic stress symptoms - for recent critical incident

Timepoint [1]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), mid-treatment (after second session - unless this also constitutes the final session in which only the post-treatment version will be administered), post-treatment (after the participant's last session) = primary timepoint, 12 weeks after treatment completion and 24 weeks after treatment completion

Primary outcome [2]

Severity of posttraumatic stress symptoms - for other previous traumatic events

Timepoint [2]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), post-treatment (after the participant's last session) = primary timepoint, 12 weeks after treatment completion and 24 weeks after treatment completion

Secondary outcome [1]

Severity of depression symptoms

Timepoint [1]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), post-treatment (after the participant's last session), 12 weeks after treatment completion and 24 weeks after treatment completion

Secondary outcome [2]

Quality of Life

Timepoint [2]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), 12 weeks after treatment completion and 24 weeks after treatment completion

Secondary outcome [3]

Sense of Coherence

Timepoint [3]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), 12 weeks after treatment completion and 24 weeks after treatment completion

Secondary outcome [4]

Safety of the treatment

Timepoint [4]

Throughout the treatment period (i.e,, when and adverse event occurs)

Secondary outcome [5]

Acceptability of the treatment

Timepoint [5]

Throughout the treatment period (i.e., when discontinuation occurs)

Secondary outcome [6]

Safety of the treatment

Timepoint [6]

At post-treatment treatment (after the participant's last session) and 24 weeks after treatment completion

Secondary outcome [7]

Acceptability of the treatment

Timepoint [7]

At post-treatment (after the participant's last session)

Secondary outcome [8]

Vividness of the memory relating to the recent critical incident

Timepoint [8]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), mid-treatment (after second session), post-treatment (after the participant's last session)

Secondary outcome [9]

Emotion regulation difficulties

Timepoint [9]

Pre-treatment (after eligibility and consent processes, up to 3 weeks before first treatment session), mid-treatment (after second session), post-treatment (after the participant's last session)

Secondary outcome [10]

Severity of anxiety symptoms

Timepoint [10]

Secondary outcome [11]

Severity of stress symptoms

Timepoint [11]

Eligibility

Key inclusion criteria

1. Be an operational employee or volunteer first responder of Ambulance Victoria.
2. Have experienced exposure to a traumatic event within the last 3 months. A traumatic event is defined as directly experiencing or witnessing in person an event that involves exposure to actual or threatened death, serious injury or sexual violence (American Psychiatric Association, 2013). It can also include learning that the traumatic event occurred to a close family member or close friend, or experiencing repeated/extreme exposure to aversive details of the traumatic event(s). Exposure to the traumatic event does not have to occur in the course of operational duties (e.g., exposure to a traumatic event in an individual’s personal life).
3. Experiencing subjective ongoing distress (i.e., subjectively defined by the participant) related to the event.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

1. Reporting acute risk of self-harm/suicide.
2. Receiving, or expecting to receive, any form of psychological treatment or support (professional or peer) during the treatment phase.
3. Likelihood of requiring changes in any medication for PTSD, depression or anxiety during the treatment phase.
4. Unable to commit to full participation in the study over a seven-month period.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Randomisation will be implemented within Qualtrics using an automated and concealed allocation process, in accordance with the principles outlined in the ICH Guidelines E9 (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, 1998)

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

A stratified randomisation design will be used to allocate participants to either EMDR-PRECI or Psychosocial Skills Training treatment groups. As region of deployment and existing levels of general trauma may be associated with outcomes, these will be included as stratifying factors in the randomisation. Region of workplace will be included as a two-level factor (rural/regional vs. metro), and general trauma as a three-level factor (PCL-5 score less than or equal to 32 vs. PCL-5 equal to 33-40 vs. PCL-5 greater than or equal to 41). This will result in six separate randomisation lists from which participants will be drawn. Upon completion of the baseline assessment, participants will be allocated to a treatment group using randomly permuted blocks within each stratum to ensure that participant allocation to the treatment groups will be approximately equal.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

This superiority trial will utilise a two-arm, parallel group randomised controlled trial design with an equal allocation ratio. Outcome measures will be assessed at baseline, mid-treatment, post-intervention (primary endpoint, measured at 3 weeks post-baseline), and follow-up at 3 months and 6 months. Primary analyses will be undertaken on an intention-to-treat basis, including all participants randomised, regardless of treatment actually received or withdrawal from the study. Mixed model repeated measures (MMRM) will be implemented to analyse the changes in primary and secondary outcomes of the PCL-5, DASS-21, WHOQOL-BREF, and SOC-29 across the assessment points of the study follow-up period. MMRM analysis is consistent with intention-to-treat principles, using all available data from each participant, including those who did not complete follow-up assessments. It is one of the preferred analytic methods for repeated measures analysis because it yields unbiased results when data are missing at random, and appropriately accounts for correlations between repeated measurements of the same participant.
The effectiveness of the trial intervention will be established using a priori planned comparisons of differential change in the primary outcome measure (PCL-5; measuring posttraumatic stress symptoms for the recent event) based on the interaction between time and treatment group, from baseline (T1) to the primary endpoint at post-treatment (T3) using MMRM modelling with a critical p value of 0.05. Additional planned contrasts for the primary outcome will examine differential group change between baseline and: mid-treatment (T1-T2), 3-month follow up (T1-T4) and 6-month follow-up (T1 to T5). MMRM analyses will also be conducted for secondary outcomes and will include the following contrasts: (1) for the DASS-21, differential change between baseline and: post-treatment (T1-T3), 3-month follow up (T1-T4) and 6-month follow-up (T1 to T5), and (2) for both WHO-QoL BREF and SOC-29, differential change between baseline and: 3-month follow up (T1-T4) and 6-month follow-up (T1 to T5). Achieved effect sizes at each time point will be expressed as standardised mean differences (SMD). The SMD provides a quantitative measure of the magnitude, or strength of the effect, and is equivalent to Cohen’s d but is based on the estimated model means and pooled estimated variances derived from the MMRM. SMD effects of 0.2 can be considered small, 0.5 corresponds to a medium effect, and 0.8 to a large effect according to Cohen’s typology (Cohen, 1988).
To support process monitoring of the underlying mechanism of action for treatment effects, appropriate modelling will be conducted to examine the directional relationship between emotion regulation difficulties (DERS-16), vividness of the memory relating to the critical incident (2 items) and posttraumatic stress symptoms (PCL-5). Analyses will be conducted across baseline, mid-treatment and post-treatment time points. Results will be reported as parameter estimates with corresponding p-values and 95% confidence intervals, indicating the strength and temporal direction of associations between variables. Where appropriate, standardised effect sizes will be reported to aid interpretation of clinical significance.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

20/11/2025

Date of last participant enrolment

Anticipated

8/09/2026

Actual

Date of last data collection

Anticipated

31/03/2027

Actual

Sample size

Target

156

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ambulance Victoria

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Emergency Management Victoria (Victorian State Government)

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Ambulance Victoria

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Monash University

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

https://www.monash.edu/researchoffice/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/07/2025

Approval date [1]

10/11/2025

Ethics approval number [1]

Summary

Brief summary

The aim of this study is to assess and compare the effectiveness of two different early -intervention treatments to reduce posttraumatic stress in paramedics following recent exposure to a traumatic event. The treatments that will be offered in the study are Eye Movement Desensitisation and Reprocessing (i.e., EMDR-PRECI) therapy and Psychosocial Skills Training. It is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms in relation to the recent critical incident, both immediately following treatment and at follow-up. Similarly, it is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms associated with other trauma events, both immediately following treatment and at follow-up.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Aron Shlonsky

Address

School of Primary and Allied Health Care, Building G, Level 3, Monash University Peninsula Campus, Frankston, Victoria 3199

Country

Australia

Phone

+61 3 9903 1131

Fax

[email protected]

Contact person for public queries

Name

Megan Dobbie

Address

Ambulance Victoria, 375 Manningham Road Doncaster VIC 3108

Country

Australia

Phone

+61 0437 114525

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Strauven

Address

Ambulance Victoria, 375 Manningham Road Doncaster VIC 3108

Country

Australia

Phone

+61 0474 225 923

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		AV EMDR RCT protocol_version 3.0.pdf
Informed consent form		Consent Form_AV_RCT_version 2_15-07-2025.pdf
Other	Explanatory Statement	Explanatory Statement_AV_RCT_version 2_15-07-2025.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