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Trial registered on ANZCTR


Registration number
ACTRN12622001267741
Ethics application status
Approved
Date submitted
7/09/2022
Date registered
26/09/2022
Date last updated
26/09/2022
Date data sharing statement initially provided
26/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a wellbeing and resilience program for emergency service personnel/first responders, their significant others and their supervisors
Scientific title
Protecting Emergency Responders with Evidence-based Interventions (PEREI); A randomised controlled trial examining the effect of a wellbeing and resilience program on wellbeing and post-traumatic stress levels in emergency service personnel/first responders, their significant others and their supervisors
Secondary ID [1] 307754 0
nil
Universal Trial Number (UTN)
Trial acronym
PEREI (PROTECTING EMERGENCY RESPONDERS WITH EVIDENCE-BASED INTERVENTIONS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological wellbeing 327328 0
Posttraumatic stress 327381 0
Depression 327382 0
Condition category
Condition code
Mental Health 324458 324458 0 0
Other mental health disorders
Mental Health 324715 324715 0 0
Depression
Mental Health 324728 324728 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to deliver quality, evidence-based programs to our three target groups (first responders, significant others, and supervisors). These programs are detailed below:

First responder program
1. Members will be provided a 7-session online supported intervention. Members will receive one module (~20-40min long) per week that they will complete independently. Members receive support from a wellbeing coach who provides email/text/phone feedback and prompts based on members’ responses during the course; the coach will continue this check in monthly for 6 months. The modules include a combination of interactive questions, short videos, and informative text. Adherence and module completion is monitored through the survey platform Qualtrics. This program builds on the work conducted in the UK (Wild et al., 2018, BMJ Open) and is based on well-established cognitive behavioural techniques. Modules target key areas such as increasing flexible and resilient thinking, addressing rumination and intrusive memories, adaptive problem solving skills to manage operational and organisational stressors, health behaviours and increasing help- seeking behaviour.

Significant other program
2. Significant supports of members will have access to a parallel wellbeing program (Be Well Plan). The Be Well Plan is a tailored approach delivered over 6 x 2hr group-based sessions that allows a person to identify their wellness goals and choose from several strategies and skills to foster resilience and wellbeing. The sessions will be delivered by a Be Well trainer over 6 weeks. The Be Well trainer will be an Allied health or para-professional. Sessions will be offered in both remote (videoconferencing) and in person formats, depending on participant preference/availabilities. Group session size is not capped. More than one facilitator can be used for larger groups (e.g., >20). Participants are able to assess their current wellbeing status via an online measurement tool called the Be Well Tracker, which is integrated into the training. Attendance will be monitored with an attendance log. The sessions are interactive in nature and cover topics covering mindfulness, self-compassion, adaptive coping, resilience skills, increasing social support, adaptive thinking or reframing, and consideration of values. Significant others will have access to a wellbeing coach (separate and independent from that provided to the member) throughout their participation with the Be Well program to assist with uptake and continued engagement with the program with the coach continuing to check in monthly for 6 months. More information on the Be Well program can be found at: https://www.bewellco.io.

Supervisor training
3. This program involves four 1-hour seminars over four weeks for members’ senior supervisors via videoconference or face to face depending on supervisor availabilities. The seminars will be an Allied health or para-professional. Attendance will be monitored with an attendance log. These seminars will ensure consistency of messaging and ongoing promotion of a wellbeing framework from an organisational context, and topics covered include those with preliminary support from prior research, including mental health education, reducing stigma, and promoting help-seeking and skills in communicating and supporting members around mental health. Supervisors at sites randomised to access the program in the first 12 months (i.e. intervention participants) will all be offered access to the seminars.
Intervention code [1] 324222 0
Prevention
Comparator / control treatment
A waitlist control group will be used across all 3 programs. After 12 months the waitlist group will be eligible for their relevant program.
Control group
Active

Outcomes
Primary outcome [1] 332268 0
Posttraumatic Stress Disorder Checklist (PCL-5)
Timepoint [1] 332268 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12 (primary time point), and 24 months post-intervention program completion
Primary outcome [2] 332269 0
Patient Health Questionnaire (PHQ-9)
Timepoint [2] 332269 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12 (primary time point), and 24 months post-intervention program completion
Primary outcome [3] 332270 0
Resilience Scale (RS)
Timepoint [3] 332270 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12 (primary time point), and 24 months post-intervention program completion
Secondary outcome [1] 412767 0
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Timepoint [1] 412767 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [2] 412769 0
Australian Quality of Life (AQol-4D)
Timepoint [2] 412769 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [3] 412770 0
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
Timepoint [3] 412770 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [4] 413111 0
Adverse Child Experience (ACE) Questionnaire
Timepoint [4] 413111 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [5] 413112 0
Health Economics Questionnaire
Timepoint [5] 413112 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [6] 413113 0
ASSIST Tobacco Subscale
Timepoint [6] 413113 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [7] 413114 0
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [7] 413114 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [8] 413115 0
Brief Resilience Scale (BRS)
Timepoint [8] 413115 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [9] 413116 0
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
Timepoint [9] 413116 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [10] 413117 0
Dimensions of Anger Scale (DAR-5)
Timepoint [10] 413117 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [11] 413118 0
Difficulties with Emotional Regulation Scale (DERS-18)
Timepoint [11] 413118 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [12] 413119 0
Generalised Anxiety Disorder Screener (GAD-7)
Timepoint [12] 413119 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [13] 413120 0
Quality of Life Scale (ICECAP-A)
Timepoint [13] 413120 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [14] 413121 0
Insomnia Severity Index (ISI)
Timepoint [14] 413121 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [15] 413122 0
Job Satisfaction Scale (JSS)
Timepoint [15] 413122 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [16] 413123 0
Life Events Checklist (LEC-5)
Timepoint [16] 413123 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [17] 413125 0
Posttraumatic Cognitions Inventory (PTCI-9)
Timepoint [17] 413125 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [18] 413126 0
Two-way Social Support Scale
Timepoint [18] 413126 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [19] 413127 0
Satisfaction with Life Scale
Timepoint [19] 413127 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [20] 413128 0
The Psychosocial Safety Climate (PSC-12) Scale
Timepoint [20] 413128 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [21] 413129 0
Operational First Responder Stress Questionnaire
Timepoint [21] 413129 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [22] 413130 0
Organisational First Responder Stress Questionnaire
Timepoint [22] 413130 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [23] 413131 0
Manager Training Questionnaire - Supervisor Confidence Scale
Timepoint [23] 413131 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [24] 413132 0
Manager Training Questionnaire – Stigma/Attitudes Scale
Timepoint [24] 413132 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [25] 413133 0
Manager Training Questionnaire – HSE for Managers
Timepoint [25] 413133 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [26] 413134 0
Mental Health Knowledge Schedule (MAKS)
Timepoint [26] 413134 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [27] 413283 0
MDRS – male depression risk scale
Timepoint [27] 413283 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [28] 413285 0
Police Stress Questionnaire - operational
Timepoint [28] 413285 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [29] 413286 0
Police Stress Questionnaire - organisational
Timepoint [29] 413286 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion
Secondary outcome [30] 413287 0
Gayed - manager training questionnaire
Timepoint [30] 413287 0
Pre program (~1 week before the intervention program starts), post program (1 week post intervention program) and 6, 12, and 24 months post-intervention program completion

Eligibility
Key inclusion criteria
First responders must be active duty within their first 5 years of service (including police, firefighters, paramedics) in Australia.
Significant others/family members with an eligible first responder participating in the member program.
Supervisors must be from a service partnered with the project. Supervisors can participate regardless of whether they supervise a first responder who is part of the members program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Serious social or mental health issues that requires significant clinical treatment or preclude participation in a wellbeing and resilience program.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation stratified by pre-defined geographical work areas relevant to the emergency service. The first responder is randomised into either intervention or control and the corresponding significant other and supervisor will be assigned the same allocation as the first responder.
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
An intent-to-treat approach (ITT) will be used, including data from all randomised participants regardless of the amount of program completion. Program noncompleters will be invited to participate in all subsequent assessments in order to minimise missing data. A multilevel model (MLM) will be used to assess the clustered longitudinal data. To assess the clinical significance of change, specific cut-point scores for relevant measures are used. These and other dichotomous outcomes (dropout) will be assessed using mixed effects logistic regression or chi-squared tests where only single follow-up data are collected. For health economic and societal evaluations, multilevel models will also be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312018 0
Charities/Societies/Foundations
Name [1] 312018 0
Movember
Country [1] 312018 0
Australia
Funding source category [2] 312020 0
Charities/Societies/Foundations
Name [2] 312020 0
Breakthrough Mental Health Research Foundation
Country [2] 312020 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 313520 0
None
Name [1] 313520 0
Address [1] 313520 0
Country [1] 313520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311438 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 311438 0
Ethics committee country [1] 311438 0
Australia
Date submitted for ethics approval [1] 311438 0
12/05/2022
Approval date [1] 311438 0
24/05/2022
Ethics approval number [1] 311438 0

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

Contacts
Principal investigator
Name 121098 0
Prof Reg Nixon
Address 121098 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd, Bedford Park SA 5042
Country 121098 0
Australia
Phone 121098 0
+61 8 82012748
Fax 121098 0
Email 121098 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 121099 0
Marja Elizabeth
Address 121099 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd, Bedford Park SA 5042
Country 121099 0
Australia
Phone 121099 0
+61 8 82015791
Fax 121099 0
Email 121099 0
marja.elizabeth@flinders.edu.au
Contact person for scientific queries
Name 121100 0
Reg Nixon
Address 121100 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd, Bedford Park SA 5042
Country 121100 0
Australia
Phone 121100 0
+61 8 82012748
Fax 121100 0
Email 121100 0
reg.nixon@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In order to maintain participant confidentiality data will only be available for group based comparisons.


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.