Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001362583
Ethics application status
Approved
Date submitted
9/12/2015
Date registered
15/12/2015
Date last updated
7/06/2021
Date data sharing statement initially provided
23/11/2018
Date results provided
7/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological strength training as an evidence based targeted intervention for the primary prevention of post-traumatic stress disorder (PTSD).
Scientific title
Efficacy of a psychological strength training program for the prevention of PTSD in fire and emergency services recruits in Western Australia
Secondary ID [1] 263025 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 270751 0
Condition category
Condition code
Mental Health 270931 270931 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four hour psychological strength training program, to be delivered over four, one hour sessions as part of initial recruit training. The one hour module were delivered throughout the duration of recruit training school (15 weeks) by a psychologist; the time for each module within each recruit school was varied to fit in with DFES scheduling requirements, with Module 1 always delivered in the first week of recruit training and Module 4 always delivered in the final week of recruit training. Modules were delivered in a group format; attendance was not recorded as attendance of all aspects of recruit training is required by DFES for graduation from recruit school.

Each one-hour MAPS session comprised a fully contained module. The MAPS precis was presented at the start and end of each session, as follows:
Creating strong MAPS:
1. Moment—Take a moment to choose the strongest option
2. Assess—Make an assessment of what the situation is, what is happening for you (internally and externally) and what outcome you would like.
3. Plan—Plan your course of action
4. Support—what support(s) might you need to follow through with the strongest possible response?

Module One was an introduction to the MAPS program. The objective of Module Two was to instruct participants in how to “take a moment” to be able to choose their response while under stress. These concepts were revisited and consolidated in Module Three, where the concept of identifying and using appropriate supports was added. The final MAPS module targeted maintenance and self-care.
Intervention code [1] 269367 0
Prevention
Comparator / control treatment
Training-as-usual: the comparison group will receive intial recruit training-as-usual without the psychological strength training component.
Control group
Active

Outcomes
Primary outcome [1] 279595 0
PTSD Symptoms (measured by PTSD Checklist-Civilian)
Timepoint [1] 279595 0
Pre-intervention (T1), immediately post-intervention (T2), 6-month follow up (T3), 12-month follow up (T4), 5 year follow-up (T5)
Secondary outcome [1] 319486 0
Depression, as measured by the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [1] 319486 0
Pre-intervention (T1), immediately post-intervention (T2), 6-month follow up (T3), 12-month follow up (T4), 5 year follow-up (T5)

Eligibility
Key inclusion criteria
Completing initial recruit training with the WA Department of Fire and Emergency Services
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There were no exclusion criteria. Participants had gone through a recruitment and screening process to be accepted into recruit school, thus if they were enrolled as a DFES recruit they were eligible for this study.

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)
Recruits within DFES are naturally grouped into ‘schools’, where a school is a cohort that completes training together. For this reason, random allocation of single subjects to treatment or control groups is not feasible. Rather, ‘schools’ will be randomly allocated to treatment or control.
As four schools were expected to participate, four sealed envelopes (two containing “TAU” and two containing “intervention”) were prepared at the start of the trial. Before contact with each school one envelope was selected, designating the condition for that school.
It was originally intended that two TFF schools would be randomly allocated to the TAU condition and two to the Intervention condition, in order to achieve the minimum number of participants required, as estimated by the power analysis. With two TFF schools scheduled in both 2012 and 2013, the study was on track with this target; however, due to reasons not communicated to the researchers, one TFF school in 2013 was cancelled by DFES after it had been allocated as an intervention group. Given the 12 month follow-up period, it was not possible to recruit an additional TFF school in 2014 and complete this project within the required timeframe.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
GLMM
According to the power program (G*Power 3.1), at a per-test alpha-level of .05, 82 participants (41 in each group) are required for an 80% chance of capturing a “small” to “moderate” Group x Time interaction (f = .158). This is the repeated measures ANOVA estimate. The Generalised Linear Mixed Model (GLMM; the statistical procedure used to test the hypotheses, as outlined below) estimate would be approximately equivalent; but with GLMM, natural attrition can occur without seriously compromising power. This is because the GLMM maximum likelihood procedure is a full estimation procedure, which uses all of the data available at each time period without being dependent on each participant providing data at each time point (Holden, Kelley, & Agarwal, 2008).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/06/2013
Date of last participant enrolment
Anticipated
Actual
1/07/2013
Date of last data collection
Anticipated
31/12/2019
Actual
1/07/2020
Sample size
Target
82
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 12410 0
6058 - Forrestfield

Funding & Sponsors
Funding source category [1] 269827 0
University
Name [1] 269827 0
Curtin University
Country [1] 269827 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley
Perth WA 6102
Country
Australia
Secondary sponsor category [1] 268859 0
None
Name [1] 268859 0
Address [1] 268859 0
Country [1] 268859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271794 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271794 0
Ethics committee country [1] 271794 0
Australia
Date submitted for ethics approval [1] 271794 0
15/06/2011
Approval date [1] 271794 0
05/10/2011
Ethics approval number [1] 271794 0
HR113/2011
Ethics committee name [2] 299280 0
Murdoch University HREC
Ethics committee address [2] 299280 0
Ethics committee country [2] 299280 0
Australia
Date submitted for ethics approval [2] 299280 0
Approval date [2] 299280 0
02/05/2017
Ethics approval number [2] 299280 0
2017/050

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

Contacts
Principal investigator
Name 33142 0
A/Prof Clare Rees
Address 33142 0
Curtin University
School of Psychology and Speech Pathology
GPO Box U1987
Perth
WA, 6845
Country 33142 0
Australia
Phone 33142 0
+61 08 9266 3442
Fax 33142 0
Email 33142 0
c.rees@curtin.edu.au
Contact person for public queries
Name 16389 0
Petra Skeffington
Address 16389 0
Curtin University
School of Psychology and Speech Pathology
GPO Box U1987
Perth
WA, 6845
Country 16389 0
Australia
Phone 16389 0
+61402312619
Fax 16389 0
Email 16389 0
petra.skeffington@curtin.edu.au
Contact person for scientific queries
Name 7317 0
Petra Skeffington
Address 7317 0
Curtin University
School of Psychology and Speech Pathology
GPO Box U1987
Perth
WA, 6845
Country 7317 0
Australia
Phone 7317 0
+61402312619
Fax 7317 0
Email 7317 0
petra.skeffington@curtin.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


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
SourceTitleYear of PublicationDOI
EmbaseThe primary prevention of PTSD in firefighters: Preliminary results of an RCT with 12-month follow-up.2016https://dx.doi.org/10.1371/journal.pone.0155873
N.B. These documents automatically identified may not have been verified by the study sponsor.