Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001023640
Ethics application status
Approved
Date submitted
7/09/2023
Date registered
20/09/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
20/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of a Community Mental Health Integrated Disaster Preparedness Intervention in Response to the 2019-2020 Black Summer Bushfires: The Phoenix Study
Scientific title
A Community Mental Health Integrated Disaster Preparedness Intervention in Response to the 2019-2020 Black Summer Bushfires: The Phoenix Study
Secondary ID [1] 301665 0
Nil known
Universal Trial Number (UTN)
U1111-1297-6372
Trial acronym
PHOENIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder 331396 0
adjustment disorder 331397 0
depression 331398 0
anxiety 331399 0
Condition category
Condition code
Mental Health 328143 328143 0 0
Anxiety
Mental Health 328144 328144 0 0
Depression
Mental Health 328207 328207 0 0
Other mental health disorders
Public Health 328208 328208 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single day workshop, conducted face-to-face at a community centre in regional NSW. The workshop will run for a duration of 8 hours and each participant will attend the workshop once. The intervention will be delivered for up to 20 participants who will receive the same intervention and simultaneously in a group setting. The workshop will be delivered by registered Clinical Psychologists with a minimum of 5 years experience and co-led by community leaders and stakeholders. The workshop is subdivided into 5 foci which serve as stand-alone modules. Each module, and thus the entire intervention, involves information provision, discussions led by community leaders and stakeholders, interactive activities such as devising preparedness, and accompanying worksheets for each module. The modules are; 1) bushfire curricula, peer support/community cohesion, 2) wellbeing and mental health literacy, 3) facing stress and coping, 4) physical preparedness, protecting your home and family, 5) feeling emotionally prepared, psychological preparedness, and 6) bringing it all together. The intervention, including all modules and worksheets, were adapted from the Community-based disaster mental health intervention (CBDMI) reported by Whelton-Mitchell (2018, PMID: 30223822). Dr. Whelton-Mitchell was responsible for adapting and tailoring the CBDMI in this intervention.
Intervention code [1] 326959 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336024 0
Acceptability of the intervention assessed by 7 items rated on a Likert-type scale and 4 open-ended questions.
Timepoint [1] 336024 0
Immediately post-intervention.
Secondary outcome [1] 426504 0
Psychological distress measured by the 10-item Kessler K-10 scale.
Timepoint [1] 426504 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.
Secondary outcome [2] 426505 0
Perceived resilience measured by the 6-item Brief Resilience Scale.
Timepoint [2] 426505 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.
Secondary outcome [3] 426506 0
Psychological preparedness for disaster as quantified by the 16-item Psychological Preparedness for Disaster Threat Scale.
Timepoint [3] 426506 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.
Secondary outcome [4] 426507 0
Help-Seeking intentions quantified by 2-items adapted from the Community-Based Disaster Mental Health Intervention.
Timepoint [4] 426507 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.
Secondary outcome [5] 426508 0
Perceived ability to cope using 4 items adapted from the Brief-COPE.
Timepoint [5] 426508 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.
Secondary outcome [6] 426509 0
Social cohesion measured by 5 items asking about perceived neighbourhood closeness of residents, willingness to help, trust, conflict, and values adapted from the social cohesion questionnaire reported by Sampson (1997).
Timepoint [6] 426509 0
Baseline, immediately post-intervention and up to 6-weeks after intervention completion.

Eligibility
Key inclusion criteria
Eligible participants are a) persons age 18 years and over, b) who self-identify as a member of the bushfire affected community in the Northern Tablelands region of NSW, c) have lived and worked in the community during the fires and continue to reside within the bushfire affected community, and d) report having been directly or indirectly impacted by the 2019 – 2020 bushfires. Direct exposure includes having protected property or livestock; having been evacuated or relocated; experiencing loss of property, family, friend/s, and/or livestock; or having served as a firefighter or first responder. Indirect exposure includes having heard recounts of the bushfires and their effects on the community second hand.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ineligible participants are those not fluent in English or individuals who reside outside of the recruitment catchment area or are judged by clinicians as under the influence of alcohol or substance or have any other significant impediment to participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
One-way repeated measures ANOVAs will be performed for quantitative data to identify changes in outcomes between pre- and post-intervention, and whether those changes were sustained up to 6-weeks after the intervention. Multilevel mixed models nested in time may also be used, as these analyses are more robust to missing data and can be used to model change trajectories over time. Where a change in score across timepoints is identified, the reliable change index will be used to assess the clinical significance of this change to provide further insight into the clinical meaningfulness and utility of the program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2023
Actual
28/09/2023
Date of last participant enrolment
Anticipated
30/10/2023
Actual
31/10/2023
Date of last data collection
Anticipated
30/01/2024
Actual
31/01/2024
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306099 0
Government body
Name [1] 306099 0
Department of Agriculture, Water and the Environment
Country [1] 306099 0
Australia
Primary sponsor type
Government body
Name
Department of Agriculture, Water and the Environment
Address
GPO Box 858, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 306568 0
None
Name [1] 306568 0
Address [1] 306568 0
Country [1] 306568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306318 0
HREC of The University of New England
Ethics committee address [1] 306318 0
Ethics committee country [1] 306318 0
Australia
Date submitted for ethics approval [1] 306318 0
18/04/2023
Approval date [1] 306318 0
28/06/2023
Ethics approval number [1] 306318 0
HE23-083

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

Contacts
Principal investigator
Name 103486 0
A/Prof Suzie Cosh
Address 103486 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 103486 0
Australia
Phone 103486 0
+61 2 6773 2073
Fax 103486 0
Email 103486 0
[email protected]
Contact person for public queries
Name 103487 0
Joanne Robinson
Address 103487 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 103487 0
Australia
Phone 103487 0
+61 2 67735508
Fax 103487 0
Email 103487 0
[email protected]
Contact person for scientific queries
Name 103488 0
Suzie Cosh
Address 103488 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 103488 0
Australia
Phone 103488 0
+61 2 6773 2073
Fax 103488 0
Email 103488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an acceptability study without a comparator group.


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.