Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000083493
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Prevalence of Resilience, Psychological Well-being, and Mental Illness in Emergency Responders
Scientific title
The Prevalence of Resilience, Psychological Well-being, and Mental Illness in Emergency Responders
Secondary ID [1] 313547 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336036 0
PTSD 336164 0
Depression 336165 0
Insomnia 336166 0
Stress 336167 0
Resilience 336168 0
Psychological Well-being 336169 0
Condition category
Condition code
Mental Health 332601 332601 0 0
Anxiety
Mental Health 332602 332602 0 0
Depression
Mental Health 332603 332603 0 0
Other mental health disorders
Neurological 332714 332714 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational, cross-sectional study utilising an online survey methodology to collect quantitative data. The once-off survey will be available to participants for a 30 day period.
The study will be conducted across various emergency responder organisations in Australia, including:
• NSW Ambulance Service (NSWAS) & Tasmanian Ambulance Service
• Australasian College of Paramedicine
• Other relevant emergency service organisations willing to participate
The online survey will be accessible via a secure web-based platform (Qualtrics) over a specified data collection period. The survey will take approximately 12 minutes to complete.
The survey will be available to participants for a 30 day period.
Observations will include participant levels of depression, PTSD, anxiety, insomnia, stress, resilience, and psychological well-being. In addition, they will also be asked demographic questions such as marital status, ethnicity, age, gender and current well-being practices.
Intervention code [1] 330138 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340118 0
Anxiety
Assessment method [1] 340118 0
Anxiety: Measured using the Anxiety subscale of the Depression Anxiety Stress Scale 21 (DASS-21).
Timepoint [1] 340118 0
Cross-sectional survey measured at a single timepoint
Primary outcome [2] 340367 0
Post-Traumatic Stress Disorder (PTSD)
Assessment method [2] 340367 0
Measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Timepoint [2] 340367 0
Cross-sectional survey measured at a single timepoint
Primary outcome [3] 340368 0
Depression
Assessment method [3] 340368 0
Depression: Measured using the Depression subscale of DASS-21.
Timepoint [3] 340368 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [1] 443875 0
Insomnia (Primary Outcome)
Assessment method [1] 443875 0
Insomnia: Measured using the Insomnia Severity Index (ISI).
Timepoint [1] 443875 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [2] 443876 0
Stress (Primary Outcome)
Assessment method [2] 443876 0
Stress: Measured using the Stress subscale of DASS-21.
Timepoint [2] 443876 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [3] 443877 0
Resilience (Primary Outcome)
Assessment method [3] 443877 0
Resilience: Measured using the 14-Item Resilience Scale (RS-14).
Timepoint [3] 443877 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [4] 443878 0
Psychological Well-being (Primary Outcome)
Assessment method [4] 443878 0
Measured using Ryff’s Scales of Psychological Well-Being 18-Item (RPWB-18).
Timepoint [4] 443878 0
Cross-sectional survey measured at a single timepoint

Eligibility
Key inclusion criteria
o Individuals aged 18 years and older.
o Currently employed as paramedics.
o Able to read and understand English.
o Provide informed consent to participate in the study.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Individuals under 18 years of age.
o Former emergency responders no longer active in their roles.
o Individuals who do not provide informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size was calculated using the G*Power software. It was determined that 323 paramedics would provide a good balance of precision for a nationwide survey with a 5% margin of error at a 95% confidence level. Adjusted for 70% response rate would be 462.
Data Preparation:
• Data Cleaning: Post-collection, data will be reviewed for completeness, consistency, and accuracy. Missing data patterns will be assessed, and appropriate imputation methods will be applied if necessary.
• Data Coding: Responses will be coded according to standardised coding schemes for each measurement instrument.
Descriptive Statistics:
• Summary Measures: Calculation of means, medians, standard deviations, and ranges for continuous variables; frequencies and percentages for categorical variables.
• Normality Assessment: Distribution of continuous variables will be assessed using skewness and kurtosis measures, as well as visual methods (e.g., histograms, Q-Q plots).
Inferential Statistics:
1. Comparative Analysis:
o t-Tests: One-sample and independent samples t-tests will be used to compare mean scores between emergency responders and general population norms.
o ANOVA: Analysis of variance will be conducted to compare means where applicable.
2. Correlation Analysis:
o Pearson Correlation Coefficient: To assess the strength and direction of relationships between continuous variables (e.g., resilience and stress levels).
o Spearman's Rank Correlation: Used when data do not meet parametric assumptions.
3. Regression Analysis:
o Multiple Linear Regression: To identify predictors of mental health outcomes, adjusting for potential confounders (e.g., age, gender, employment status).
o Logistic Regression: For dichotomous outcomes, assessing the odds ratios of developing specific mental health conditions based on predictor variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/12/2024
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
1000
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS

Funding & Sponsors
Funding source category [1] 318009 0
University
Name [1] 318009 0
Griffith University
Country [1] 318009 0
Australia
Primary sponsor type
University
Name
Griffith University
Country
Australia
Secondary sponsor category [1] 320351 0
None
Name [1] 320351 0
Country [1] 320351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316669 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316669 0
Ethics committee country [1] 316669 0
Australia
Date submitted for ethics approval [1] 316669 0
21/02/2024
Approval date [1] 316669 0
21/02/2024
Ethics approval number [1] 316669 0
GU2024/072

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138598 0
Ms Abbie Little
Address 138598 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138598 0
Australia
Phone 138598 0
+61417128159
Email 138598 0
abbie.little@griffithuni.edu.au
Contact person for public queries
Name 138599 0
Abbie Little
Address 138599 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138599 0
Australia
Phone 138599 0
+61417128159
Email 138599 0
abbie.little@griffithuni.edu.au
Contact person for scientific queries
Name 138600 0
Abbie Little
Address 138600 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138600 0
Australia
Phone 138600 0
+61417128159
Email 138600 0
abbie.little@griffithuni.edu.au

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:
• The public upon request and principle investigator discretion

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified raw data in a excel spread sheet

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
3 months post publication

To:
around September 2025

Where can requests to access individual participant data be made, or data be obtained directly?
• Through contacting the principle investigator by email: abbie.little@griffithuni.edu.au

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.