Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000321347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/03/2026
Date registered
Help: Date registered
13/03/2026
Date last updated
Help: Date last updated
15/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-delivered Wellbeing Training for First Responders
Scientific title
Internet-delivered Wellbeing Training for Australian First Responders: A Three-Arm Randomised Controlled Trial
Additional trial identifiers [1] 315844 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stress 339890 0
Anxiety 339891 0
Depression 339893 0
Post-traumatic Stress Disorder 340948 0
Wellbeing 340949 0
Resilience 340950 0
Condition category
Condition code
Mental Health 335842 335842 0 0
Depression
Mental Health 336128 336128 0 0
Anxiety
Mental Health 336129 336129 0 0
Other mental health disorders
Public Health 336713 336713 0 0
Health promotion/education
Public Health 336715 336715 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will be randomised into one of three conditions: (1) the intervention condition (Agile Mind), (2) the comparator intervention condition (Wellbeing), or (3) the control group (Waitlist Control).

The intervention is a self-paced online training program called 'Agile Mind', designed to support the wellbeing of emergency service workers and tailored to their experiences. It was co-designed by occupational mental health experts, clinical psychologists, and a collaborative working group with lived experience as emergency service workers. The content of Agile Mind was based on the principles of Acceptance and Commitment Therapy, an evidence-based psychotherapy intervention that is used to increase psychological flexibility. Psychological flexibility is the ability to accept uncomfortable situations and respond in ways that align with personal values, and was chosen to be the focus of Agile Mind due to previous research suggesting that it is protective against the development of mental health conditions (especially PTSD).

Agile Mind contains 4 modules, with each one containing psychoeducational videos, breathing and grounding exercises, along with written reflection activities:
• Module 1 - Building an Agile Mind: Introduces the concept of psychological flexibility and its important role in maintaining wellbeing in emergency service work. Also presents an overview of the critical elements of psychological flexibility that will be covered in more detail in the subsequent modules, which include being present, becoming open, and valued action.
• Module 2 - Staying Present in the Here and Now: Teaches emergency service workers how to apply different present-moment awareness skills both during and after their shifts.
• Module 3 - Opening Up to Difficult Experiences: Discusses the impact of psychological fusion, how to apply de-fusion techniques, and the importance of accepting difficult thoughts and experiences instead of avoiding them.
• Module 4 - Taking Action Based on Your Values: Teaches the difference between values and goals, setting value-based SMART goals, and dealing with conflicting values in emergency service work.

Each module will take approximately 20 minutes to complete. One module is to be completed each week over four consecutive weeks, and participants will be encouraged to practise the skills covered in the previous module before moving on to the next one.

Data on adherence and usage of the intervention will be collected via the program platform and will include modules started, completed, and time in program.
Intervention code [1] 332651 0
Prevention
Description of the comparator or control
The first comparator 'Wellbeing' intervention is a self-paced online training program, created by occupational mental health experts and clinicians It was designed to mirror generalised wellbeing programs and advice offered within occupational (and generalised) settings.

The Wellbeing intervention contains 4 modules, with each one containing psychoeducational videos and multiple-choice questions to check understanding of the content:
• Module 1 - Stress: Outlines the causes and impacts of the stress, including chronic stress. Also discusses the cumulative effect of traumatic events and common symptoms of Post-traumatic Stress Disorder (PTSD).
• Module 2 - Heroes Ask for Help: Explores how to recognise common mental health conditions and how to seek support for them. Also presents the different categories of reasonable adjustments that can help support mental health in the workplace.
• Module 3 - Ways to Wellbeing: Covers the elements of wellbeing and details five internationally-recognised evidence-based strategies for enhancing wellbeing.
• Module 4 - The Importance of Lifestyle Factors: Discusses the importance of good nutrition and sleep, with a focus on shift workers. Also highlights the positive impacts of physical activity and the negative impacts of alcohol, smoking, and vaping.

One module is to be completed each week over four consecutive weeks (approximately 20min per module), and participants will be encouraged to practise the skills covered in the previous module before moving on to the next one.

Data on adherence and usage of the intervention will be collected via the program platform and will include modules started, completed, and time in program.

The second comparator group is a waitlist control group.

All groups will be offered access to the two active programs post the final follow-up dependent on efficacy of programs.
Control group
Active

Outcomes
Primary outcome [1] 343667 0
Changes in self-reported wellbeing.
Timepoint [1] 343667 0
Baseline, post-intervention (4 weeks after baseline)
Secondary outcome [1] 455235 0
Changes in self-reported depression symptoms.
Timepoint [1] 455235 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [2] 455236 0
Changes in self-reported anxiety symptoms.
Timepoint [2] 455236 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [3] 455237 0
Changes in self-reported stress symptoms.
Timepoint [3] 455237 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [4] 455238 0
Changes in self-reported Post-traumatic Stress Disorder (PTSD) symptoms.
Timepoint [4] 455238 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [5] 455240 0
Changes in self-reported psychological flexibility.
Timepoint [5] 455240 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [6] 455241 0
Changes in self-reported resilience.
Timepoint [6] 455241 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [7] 455242 0
Changes in self-reported presenteeism and absenteeism (a composite measure of work performance will be derived)
Timepoint [7] 455242 0
Baseline, post-intervention (4 weeks after baseline), and follow-up (4 months after baseline).
Secondary outcome [8] 455243 0
Intervention Acceptability.
Timepoint [8] 455243 0
Post-intervention (4 weeks after baseline).
Secondary outcome [9] 455244 0
Intervention Appropriateness.
Timepoint [9] 455244 0
Post-intervention (4 weeks after baseline).
Secondary outcome [10] 455673 0
Intervention feasibility.
Timepoint [10] 455673 0
Post-intervention (4 weeks after baseline).
Secondary outcome [11] 455674 0
Intervention Feedback
Timepoint [11] 455674 0
Post-intervention (4 weeks after baseline).
Secondary outcome [12] 458630 0
Intervention Engagement.
Timepoint [12] 458630 0
Throughout study duration, after baseline.
Secondary outcome [13] 458990 0
Longer term changes in self-reported Wellbeing
Timepoint [13] 458990 0
Wellbeing at follow-up (4 months after baseline).

Eligibility
Key inclusion criteria
Participants will need to meet the following criteria:
1. Aged over 18 years.
2. Currently working or volunteering (or have previously worked or volunteered) within an emergency service agency (e.g. Police, Fire services, Ambulance, Rescue services).
3. Screening indicates either ‘None-minimal’, ‘Mild’, or ‘Moderate’ symptoms of depression, demonstrated by a score of 14 or less on the Patient Health Questionnaire.
4. Screening indicates either ‘Minimal’, ‘Mild’, or ‘Moderate’ symptoms of anxiety, demonstrated by a score of 14 or less on the Generalized Anxiety Disorder 7-item scale.
5. Screening indicates unlikely PTSD, demonstrated by scoring less than 3 for all items within each of the three symptom clusters on the Posttraumatic Stress Disorder 8-item scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Screening indicates either ‘Moderately Severe’ or ‘Severe’ symptoms of depression, demonstrated by a score of 15 or more on the Patient Health Questionnaire).
2. Screening indicates ‘Severe’ symptoms of anxiety, as indicated by a score of 15 or more on the Generalized Anxiety Disorder 7-item scale.
3. Screening indicates likely PTSD, demonstrated by scoring a minimum of 3 on at least one item in each of the three symptom clusters on the Posttraumatic Stress Disorder 8-item scale.

Participants who indicate moderately severe-severe depression, severe anxiety, or likely PTSD will be provided with recommended care options and details for support services, including face-to-face/telehealth treatment with clinical psychologists.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed, as it was performed by the randomiser feature within the Black Dog Institute (BDI) Research Engine.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation feature provided by computer software (BDI Research Engine).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Systematic reviews of the effects of universal online interventions on improving wellbeing among workers and the general population (with no set psychological inclusion criteria) have been shown to produce small to moderate effect sizes post-intervention (Carolyn et al., 2017; Groot et al., 2023). The current study was conservatively powered to detect a small effect size (Cohen’s d = 0.30) between Arm 1 (i.e. Agile Mind training) and each of the control comparator arms (i.e. Generic wellbeing training and waitlist control). Assuming a correlation of 0.50 between occasions of measurement, a = 0.05, power = 0.8, approximately 176 participants per arm are required. Allowing for up to 30% attrition, the target total sample of size has been set at 755.

Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomised, regardless of actual receipt or uptake of the intervention or withdrawal from the study. Mixed-model repeated measures analysis will be used for the primary outcome and continuously scaled secondary outcome variables. The model will include factors of trial arm (Agile Mind, General Wellbeing and Waitlist Control), occasion of measurement (baseline, 4-week follow-up, and 3-month follow-up) and their interaction.

The primary outcome for the comparison of Arm 1 to Arms 2 and 3 will be assessed by a planned comparison of the difference between groups in change of the primary outcome variable (positive and negative interpretation bias) from baseline to post-training. An unstructured residual variance-covariance matrix will accommodate within-participant dependency. Tests of significance will use the Kenward-Roger method of df adjustment based on the observed information matrix. Analyses of the secondary outcomes’ differential change from baseline to follow-up and of secondary outcome variables will follow the same methods as the primary outcome. Cross-sectional effect sizes (standardised mean differences; SMDs) will be estimated using differences in marginal means post intervention and at follow-up divided by the square root of the model residual variance at the corresponding time.

As the comparisons of Arm 1 to each of the 2 other conditions are considered independent studies, which might normally be undertaken separately as comparisons of Agile Mind to no intervention and Agile Mind to current routine practice, no adjustment for multiple testing arising from the two comparison conditions is proposed. The study is not powered to detect the very small difference between the two control conditions.

A priori–defined sub-group analyses will be conducted to examine the effect of intervention uptake, and help-seeking.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2026
Actual
1/06/2026
Date of last participant enrolment
Anticipated
15/06/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
755
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320445 0
Government body
Name [1] 320445 0
Australian Government Department of Health and Aged Care
Country [1] 320445 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
Country
Australia
Secondary sponsor category [1] 323264 0
None
Name [1] 323264 0
Address [1] 323264 0
Country [1] 323264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318997 0
The University of New South Wales Committee C
Ethics committee address [1] 318997 0
Ethics committee country [1] 318997 0
Australia
Date submitted for ethics approval [1] 318997 0
23/01/2026
Approval date [1] 318997 0
02/02/2026
Ethics approval number [1] 318997 0
iRECS9839

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145918 0
Dr Mark Deady
Address 145918 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 145918 0
Australia
Phone 145918 0
+61 2 9065 9144
Fax 145918 0
Email 145918 0
[email protected]
Contact person for public queries
Name 145919 0
Mark Deady
Address 145919 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 145919 0
Australia
Phone 145919 0
+61 2 9065 9144
Fax 145919 0
Email 145919 0
[email protected]
Contact person for scientific queries
Name 145920 0
Mark Deady
Address 145920 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 145920 0
Australia
Phone 145920 0
+61 2 9065 9144
Fax 145920 0
Email 145920 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.