Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001212448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/12/2024
Date registered
Help: Date registered
3/11/2025
Date last updated
Help: Date last updated
3/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A community-based preventative mental wellbeing preparedness program for adults living in rural communities: The Equip Study
Scientific title
A community-based preventative mental wellbeing preparedness program for adults living in rural communities that are prone to fire, drought and extreme weather events: The Equip Study
Additional trial identifiers [1] 313511 0
None
Universal Trial Number (UTN)
U1111-1330-7963
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
wellbeing 335940 0
depression 335941 0
anxiety 335942 0
resilience 338832 0
Condition category
Condition code
Mental Health 332526 332526 0 0
Anxiety
Mental Health 332529 332529 0 0
Depression
Mental Health 332530 332530 0 0
Other mental health disorders
Public Health 332531 332531 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a modular workshop comprising 7 modules (see below) addressing wellbeing through enhancing social cohesion, coping, preparedness, resilience, psychological flexibility, and mental health. The intervention will be implemented in 9 communities (i.e. sites) in 3 sequential steps (3 sites per step). Steps are fixed to occur sequentially across 2026, with each step lasting approximately 3 months. Which sites are allocated to which steps will be randomised by a Chief Investigator stratified by state. The total duration of the intervention across all nine sites is approximately 9 months.

The intervention is co-delivered face to face within each local community by specific members of the project team and community co-facilitators. The intervention is delivered in line with community preferences (e.g., intensity, delivery mode, timing within the step, community location) and tailored to community needs. These community preferences are guided by the use of a community advisory committees in each study site.
Community co-facilitators with relevant lived experience will be identified through local advisory groups and trained by the Chief Investigator team to ensure:
a) that the program meets local needs,
b) that local knowledge is included in the program,
c) community ownership of the program,
d) ongoing capacity in each community beyond the life of this project through upskilling community members.

Co-facilitator training will consist of group-based training for each community. This training will occur approximately 1-4weeks before the intervention is set to be delivered at that site.

The intervention will be delivered in-person for approximately 50 participants (per site) who will receive the same intervention and simultaneously in a group setting. The intervention will be delivered specific members of the CI team and include registered Psychologists with a minimum of 5 years experience, and will be co-led by community co-facilitators. The intervention is subdivided into 7 foci which serve as stand-alone modules, each 1 hour in duration. Each module, and thus the entire intervention, involves information provision, discussions, interactive activities such as devising preparedness, and accompanying worksheets. The modules are; 1) working together - peer support and community cohesion, 2) protecting your home and family = physical preparedness, 3) feeling emotionally prepared, part 1 - psychological preparedness for acute events (e.g., fire), 4) feeling emotionally prepared, part 2 - psychological preparedness for subacute events (e.g., drought), 5) wellbeing and burnout - facing stress and challenges, mental health literacy, stress and coping, 6) bringing it all together - consolidation of skills, and 7) future planning - sustainability. The intervention, including all modules and worksheets, were adapted from the Community-based disaster mental health intervention (CBDMI) reported by Welton-Mitchell (2018, PMID: 30223822). Adherence to the intervention will be assessed through workshop attendance and completion of surveys.
Intervention code [1] 330083 0
Prevention
Intervention code [2] 330182 0
Behaviour
Description of the comparator or control
Baseline data are to be collected at two time-points. All participants complete a cohort-wide baseline survey in 2026, prior to initiation of any intervention delivery. This serves as a shared reference point for longitudinal comparisons across the entire sample. Second, a cluster-specific baseline is collected one month prior to each site’s assigned intervention step, capturing pre-program outcomes at the local level. Observations obtained during the control (pre-intervention) period within each cluster will serve as the comparator for evaluating intervention effects.
Control group
Active

Outcomes
Primary outcome [1] 340044 0
Mental Wellbeing
Timepoint [1] 340044 0
Baseline, Pre-intervention implementation (approx. 1 month pre-intervention), immediately post intervention, 12 months post baseline, 24 months post baseline, and 36 months post baseline.
Secondary outcome [1] 442469 0
Psychological distress
Timepoint [1] 442469 0
Baseline, Pre-intervention implementation (approx. 1 month pre-intervention), immediately post intervention, 12 months post baseline, 24 months post baseline, and 36 months post baseline.
Secondary outcome [2] 442473 0
Psychological preparedness
Timepoint [2] 442473 0
Baseline, Pre-intervention implementation (approx. 1 month pre-intervention), immediately post intervention, 12 months post baseline, 24 months post baseline, and 36 months post baseline.
Secondary outcome [3] 442476 0
Coping
Timepoint [3] 442476 0
Baseline, Pre-intervention implementation (approx. 1 month pre-intervention), immediately post intervention, 12 months post baseline, 24 months post baseline, and 36 months post baseline.
Secondary outcome [4] 442477 0
Alcohol, Smoking and Substance Involvement
Timepoint [4] 442477 0
Baseline, immediately post intervention, 12 and 36 months post baseline.
Secondary outcome [5] 442482 0
Help seeking
Timepoint [5] 442482 0
Baseline, immediately post intervention, 12 and 36 months post baseline
Secondary outcome [6] 442483 0
Resilience
Timepoint [6] 442483 0
Baseline, immediately post intervention, 12 and 36 months post baseline
Secondary outcome [7] 442484 0
Psychological inflexibility
Timepoint [7] 442484 0
Baseline, immediately post intervention, 12 and 36 months post baseline
Secondary outcome [8] 442485 0
Social cohesion (collective efficacy)
Timepoint [8] 442485 0
Baseline, immediately post intervention, 12 and 36 months post baseline
Secondary outcome [9] 442486 0
Community Resilience
Timepoint [9] 442486 0
Baseline, immediately post intervention, 12 and 36 months post baseline.
Secondary outcome [10] 442488 0
Economic evaluation
Timepoint [10] 442488 0
Baseline, 12 and 36 months post baseline.
Secondary outcome [11] 442489 0
Qualitative interviews - composite outcome - satisfaction and perceived helpfulness of the intervention
Timepoint [11] 442489 0
Once between 4-6 weeks post intervention
Secondary outcome [12] 448826 0
Health economics - healthcare costs
Timepoint [12] 448826 0
Baseline, 12 months post baseline, 36 months post baseline.

Eligibility
Key inclusion criteria
Adults aged 18 years or older; able to provide informed consent; residents of each community’s catchment area.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Persons not fluent in English; individuals who reside out of the community’s catchment area; those judged by clinicians at eligibility assessment/recruitment as having another significant impediment to participation (e.g., psychosis, dementia).

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. Randomisation will occur after the recruitment of the sites. There is no concealment of crossover date from study participants who will know the time at which the intervention will be implemented. Study participants, community connectors, and local advisory groups will be blinded to the sequence order of other clusters in their state and other states. Independent data collectors will remain blinded to the sequence order and participants' baseline scores.
Generic numeric codes will be used to blind the data analyst as to the names and locations of each cluster, and also to when the intervention was implemented at each cluster, and whether specific individuals had been exposed to the intervention in intention to treat.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated and unmodifiable sequence of randomly permuted variable numbers (representing site/cluster and the order of delivery) will be generated, stratified by State (NSW, WA, and SA). The unit of randomisation is the site/cluster within a State. Sites will be randomised to the intervention in three steps, with three sites receiving the intervention per step (3 per step @ 9 steps, k=9 sites).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped-wedge, observations obtained during the non-exposed period serve as the comparator.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power: Statistical power was calculated under a range of intra-cluster correlations (ICC 0.02-0.05). Based on prior work and our pilot feasibility trial, a 3-unit change in wellbeing was considered the minimal clinically important difference. With N=450 persons recruited across k=9 clusters in 3 steps, and the primary outcome measured at t=6 time points, there are up to yi=2,700 observations of primary and secondary outcomes. With a baseline sample of N=450, the trial will have 85% power to detect a 3-unit change in wellbeing p=0.05 (two-sided) with ICC=0.03, allowing for 20% attrition from baseline to post-intervention.

Statistical analysis plan: the primary and secondary outcomes will be analysed according to a predefined analysis plan using linear mixed effect regression, with random effects for clusters and fixed effect for calendar time and treatment. Potential effect modifiers in covariate-adjusted analysis include age, gender, farming household, emergency services volunteer, and climate change beliefs. Primary analyses will be performed on intention-to-treat principles. Secondary analyses will be performed per-protocol.

Health economic analysis: health economic analysis, led by an experienced health economist will consider health and societal perspectives. The cost-effectiveness will estimate the incremental costs and outcomes measured in the outcome evaluation in Australian dollars in the final year of the project, including both pharmaceutical and medical costs. A social return on investment will also be conducted as a complementary analysis to understand the value of the intervention from a societal or community perspective.

Qualitative analysis: interviews will be analysed using inductive thematic analysis to explore acceptability, satisfaction, perceived helpfulness, (dis)preferred components, and implementation strategies. These data will inform understanding of processes and guide wider implementation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 317960 0
Government body
Name [1] 317960 0
Australian Government Department of Health and Aged Care - Medical Research Future Fund - Million Minds Mission Mental Health Research Mission
Country [1] 317960 0
Australia
Primary sponsor type
University
Name
University of New England
Address
Country
Australia
Secondary sponsor category [1] 320300 0
None
Name [1] 320300 0
Address [1] 320300 0
Country [1] 320300 0
Other collaborator category [1] 283315 0
University
Name [1] 283315 0
The University of Adelaide
Address [1] 283315 0
Country [1] 283315 0
Australia
Other collaborator category [2] 283316 0
University
Name [2] 283316 0
Curtain University
Address [2] 283316 0
Country [2] 283316 0
Australia
Other collaborator category [3] 283590 0
University
Name [3] 283590 0
Federation University
Address [3] 283590 0
Country [3] 283590 0
Australia
Other collaborator category [4] 283591 0
University
Name [4] 283591 0
Deakin University
Address [4] 283591 0
Country [4] 283591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316632 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 316632 0
Ethics committee country [1] 316632 0
Australia
Date submitted for ethics approval [1] 316632 0
28/02/2025
Approval date [1] 316632 0
30/05/2025
Ethics approval number [1] 316632 0
HE-2025-2207-2748

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

Contacts
Principal investigator
Name 138474 0
A/Prof Suzanne Cosh
Address 138474 0
University of Adelaide, SA, 5005
Country 138474 0
Australia
Phone 138474 0
+61 2 6773 2073
Fax 138474 0
Email 138474 0
[email protected]
Contact person for public queries
Name 138475 0
Suzanne Cosh
Address 138475 0
University of Adelaide, SA, 5005
Country 138475 0
Australia
Phone 138475 0
+61 2 6773 2073
Fax 138475 0
Email 138475 0
[email protected]
Contact person for scientific queries
Name 138476 0
Suzanne Cosh
Address 138476 0
University of Adelaide, SA, 5005
Country 138476 0
Australia
Phone 138476 0
+61 2 6773 2073
Fax 138476 0
Email 138476 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

• Industry stakeholders

Conditions for requesting access:
• Only researchers or stakeholders who provide a methodologically sound, ethics approved proposal, case-by-case basis at the discretion of Primary Sponsor.

What individual participant data might be shared?
• De-identified individual participant data underlying published results.

What types of analyses could be done with individual participant data?
• Individual patient data meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months following main results publication; no end date determined.

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator; contact details available in the registration.

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.