Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001294246
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
31/07/2018
Date last updated
31/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
FitMind: Testing the effect of a pre-briefing program on help-seeking behaviour and symptoms of mental disorder in firefighters
Scientific title
FitMind: Testing the effect of a pre-briefing program on help-seeking behaviours and symptoms of mental disorder in firefighters.
Secondary ID [1] 295348 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 308559 0
Alcohol use disorder 308560 0
Post-traumatic disorder 308561 0
Condition category
Condition code
Other 307843 307843 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy of the "FitMind" program, a pre-briefing, resilience building educational program for firefighters, will be examined. The study will employ a 2 (Treatment Condition) x 5 (Assessment Point) design. Participants will be firefighters recruited from Fire & Rescue New South Wales. They will be randomly allocated to either:
(a) Control group- training as usual, or
(b) FitMind pre-briefing, which involves watching three DVDs approximately 30 minutes in total length, featuring real firefighters talking about some of the common, yet challenging experiences most firefighters will face in their career. The DVDs are designed to enhance help-seeking behaviour in firefighters, by encouraging them to talk to and get support from their peers, family or health professionals.

Working in conjunction with FRNSW, potential participants will be identified through the recruit and regular update training program at FRNSW. Each class of participants will be randomized to treatment condition prior to researchers visiting the training centre. Researchers will attend the training centres at a pre-arranged time to briefly introduce the study to each class of training firefighters during a classroom training session, and participants will be provided with a copy of the participant information sheet and consent form. If they choose to participate in the study, they may then complete the questionnaire and hand it directly back to the researchers. Following the completion of the questionnaire, participants in the FitMind condition will then be shown the FitMind DVDs for approximately 30 minutes in total length.

To monitor adherence, participants will be shown the FitMind videos by the experimenter if they attend the session and sign their consent. Their attendance will be logged using the consent forms and the experimenter will then play the videos upon completion of the questionnaire.

Participants in the control condition will continue their training as per usual. Participants will be contacted via email inviting them to complete the follow up questionnaire online at six months, one year, two years and three years follow up. Participants will also be phoned within one week of receiving the email to ensure that they have received and understood it on their work phone numbers.
Intervention code [1] 301669 0
Prevention
Intervention code [2] 301670 0
Early detection / Screening
Comparator / control treatment
Participants in the control condition will not be watching the FitMind DVDs, and will be undergoing the usual training that they would otherwise receive from the firebrigade.

Participants in the control group will complete the (a) pre-intervention, and (b) six months, (c) one year, (d) two year and (e) three year follow up and the same time points as the intervention group.

All participants will be contacted via email inviting them to complete the follow up questionnaire online at six months, one year, two years and three years follow up. Participants will also be phoned within one week of receiving the email to ensure that they have received and understood it on their work phone numbers.
Control group
Active

Outcomes
Primary outcome [1] 306497 0
Help-seeking opinions 2-item scale (developed for the current study). Participants will be asked to rate how likely (5-point likert scale) they are to seek support if they were experiencing stress or any other psychological difficulties from a range of different support systems (e.g. friends, chaplain, etc.) A sum score will be calculated to determine likelihood of help-seeking.
Timepoint [1] 306497 0
(a) Pre-intervention, and (b) six months, (c) one year, (d) two year and (e) three year follow up.
Secondary outcome [1] 348670 0
Kessler Psychological Distress Scale- 6 item version (K6; Kessler et al, 2002)
Timepoint [1] 348670 0
(a) Pre-intervention, and (b) six months, (c) one year, (d) two year and (e) three year follow up.
Secondary outcome [2] 348671 0
Post-Traumatic Checklist- 4 item version (PCL-4; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996)
Timepoint [2] 348671 0
(a) Pre-intervention, and (b) six months, (c) one year, (d) two year and (e) three year follow up.
Secondary outcome [3] 348672 0
Stigmatising beliefs on mental health (developed for the current study). Participants will be asked to rate their level of agreement (5-point likert scale) on 2 items: (a) It is likely that most firefighters will need help to cope with the stress of the job at some point during their career, and (b)Firefighters who report stress reactions tend to be weak. A sum score will be calculated to determine level of stigmatising beliefs.
Timepoint [3] 348672 0
(a) Pre-intervention, and (b) six months, (c) one year, (d) two year and (e) three year follow up.

Eligibility
Key inclusion criteria
Firefighters who are undergoing their training with FRNSW.
Retained or permanent firefighters recruited through the Alexandria training centre in addition to other training centres around NSW (Albion Park, Armidale, Deniliquin, Kempsey, Penrith or Wellington).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age
Not a current firefighter undergoing training with FRNSW

Study design
Purpose of the study
Educational / counselling / training
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.
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
A series of repeated measures ANOVAS and t-tests will be conducted.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
22/09/2015
Date of last data collection
Anticipated
31/10/2018
Actual
Sample size
Target
400
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299941 0
Government body
Name [1] 299941 0
Australian Research Council (ARC)
Country [1] 299941 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 299318 0
Government body
Name [1] 299318 0
Fire & Rescue NSW (formerly the NSW Fire Brigade)
Address [1] 299318 0
1 Amarina Avenue, Greenacre NSW 2190
Country [1] 299318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300808 0
The University of Sydney Human Research Ethics Committee [EC00145]
Ethics committee address [1] 300808 0
Ethics committee country [1] 300808 0
Australia
Date submitted for ethics approval [1] 300808 0
24/02/2009
Approval date [1] 300808 0
03/03/2009
Ethics approval number [1] 300808 0
03-2009/11607; 2014/334

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

Contacts
Principal investigator
Name 84878 0
Dr Helen Paterson
Address 84878 0
A18 - Brennan MacCallum
The University of Sydney
NSW 2006 Australia
Country 84878 0
Australia
Phone 84878 0
+61 2 9036 9403
Fax 84878 0
Email 84878 0
[email protected]
Contact person for public queries
Name 84879 0
Helen Paterson
Address 84879 0
A18 - Brennan MacCallum
The University of Sydney
NSW 2006 Australia
Country 84879 0
Australia
Phone 84879 0
+61 2 9036 9403
Fax 84879 0
Email 84879 0
[email protected]
Contact person for scientific queries
Name 84880 0
Samuel Harvey
Address 84880 0
The Black Dog Institute
Hospital Road
Randwick
NSW 2031
Country 84880 0
Australia
Phone 84880 0
+612 9382 8356
Fax 84880 0
Email 84880 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4717Study results articleYes Cite Tan, Leona MPsych; Harvey, Samuel B. PhD; De... [More Details]

Documents added automatically
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