Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001457831
Ethics application status
Approved
Date submitted
6/09/2021
Date registered
26/10/2021
Date last updated
26/10/2021
Date data sharing statement initially provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of workplace mental health screening on help-seeking behaviour in first responders
Scientific title
Screening In First Responders Trial (SIFT): A cluster randomised controlled trial evaluating the effects of workplace mental health screening with feedback tailored to current symptom levels versus screening without tailored feedback on help-seeking behaviours in first responders.
Secondary ID [1] 304919 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
SIFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking behaviour for psychological distress in first responders after workplace mental health screening. 323061 0
Mental health of first responders. 323062 0
Condition category
Condition code
Mental Health 320640 320640 0 0
Depression
Mental Health 320641 320641 0 0
Anxiety
Mental Health 321066 321066 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s)/exposure: There are two arms to this trial:
Arm 1 (Intervention): Screening followed by feedback tailored to participants’ level of psychological distress as assessed through the K6 and provided at baseline and follow-up. Those reporting minimal psychological distress (K6 score of less than 14) will receive feedback stating it is unlikely they are experiencing a common mental health disorder, but if they feel they would benefit from some more support or a mental health care plan, to contact their GP or workplace support team to discuss available options. Those reporting moderate/subsyndromal psychological distress (K6=14-18) will receive feedback that they are currently experiencing symptoms of psychological distress which may be due to (or progress to) a common mental health disorder, and that to address these symptoms they can seek internal supports from their workplace (i.e., wellbeing team, EAP) or external supports (i.e., online mental health tools). Finally, those reporting significant psychological distress (K6 >18) will receive feedback that they are currently experiencing significant symptoms of psychological distress, which may be due to a common mental health disorder, and that to address these symptoms they can seek internal supports from their workplace (i.e., wellbeing team, EAP) or external supports (i.e., seeing their General Practitioner, online mental health tools).
Arm 2 (Control): Screening followed by generic feedback, not tailored to level of psychological distress. Tailored feedback provided at follow-up.
At baseline, all participants in this study will complete a brief, 2-minute, mental health screening questionnaire, which assesses their level of psychological distress. Psychological distress will be measured using the 6-item Kessler Psychological Distress Scale or ‘K6’ questionnaire (Kessler et al., 2002). The screening questionnaire also assesses help-seeking behaviour (using an adapted version of the Actual Help-Seeking Questionnaire AHSQ; Rickwood, Deane, Wilson, & Ciarrochi, 2005) and a checklist assessing exposure to critical incidents (Harvey et al, 2016).
At the completion of the baseline questionnaire, intervention participants will be provided feedback tailored to their level of psychological distress scores. This feedback includes specific information on where they can seek help for their psychological distress, with the aim to promote help-seeking. Specifically, participants receive one of three tailored feedback options depending on the following K6 scores: (i) reporting minimal psychological distress (scoring < 14 on the K6), (ii) reporting subsyndromal psychological distress (scoring 14-18 on the K6), (iii) reporting considerable psychological distress (scoring > 18 on the K6).
Three months later, all participants in this study will complete the same 2-minute mental health screening questionnaire again. Help-seeking will be assessed to monitor adherence. This time, both intervention and control participants will be provided feedback tailored to their psychological distress scores identical to that provided to intervention participants at the baseline questionnaire.
The intervention will be delivered entirely online, provided individually to participants. Participants can select whether to complete the screening questionnaire either at work during their shift, or at home in their personal time. The duration of the study for any participant will conclude after the 3-month follow-up assessment.
References:
Kessler, R. C., Andrews, G., Colpe, L. J., Hiripi, E., Mroczek, D. K., Normand, S. L., . . . Zaslavsky, A. M. (2002). Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med, 32(6), 959-976. doi:10.1017/s0033291702006074
Rickwood, D., Deane, F. P., Wilson, C. J., & Ciarrochi, J. (2005). Young people’s help-seeking for mental health problems. Australian e-Journal for the Advancement of Mental Health, 4(3), 218-251. doi:10.5172/jamh.4.3.218
Harvey et al. (2016). The mental health of fire-fighters: An examination of the impact of repeated trauma exposure. ANZJP. 50(7). 649-658
Intervention code [1] 321313 0
Early detection / Screening
Intervention code [2] 321314 0
Prevention
Comparator / control treatment
A waitlist control group will form the comparison treatment in this study. Participants in the control group will complete the same mental health screening that the intervention group receive. However, control participants will receive generic feedback irrespective of their level of psychological distress. Specifically, they will receive feedback that their mental health will be measured in 3-months, at which time they will receive personalised feedback, but if needed they can seek support from their colleagues, leaders, or GP. They will be given tailored feedback (equivalent to that received by the intervention group) after completing the 3-month follow-up survey.
Control group
Active

Outcomes
Primary outcome [1] 328455 0
Help-seeking behaviour and type of help sought, as measured by an adapted version of the Actual Help-Seeking Questionnaire (Rickwood, Deane, Wilson, & Ciarrochi, 2005).
Timepoint [1] 328455 0
Baseline and 3-month follow-up.
Secondary outcome [1] 399082 0
Psychological distress, as measured by the K6 scale.
Timepoint [1] 399082 0
Baseline and 3-month follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study includes:
1. Age 18 years or older.
2. Currently working as a firefighter or rescue personnel and employed by partnering organisation (Fire & Rescue New South Wales).
3. Currently residing in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No formal exclusion criteria apply to this study. Only eligible participants will be invited and allowed to participate.

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 concealment was done by central randomisation via computer. Participants are allocated to intervention or control groups according to their cluster, being the geographical location (i.e., station/workplace) they work in. This helps avoid contamination between the intervention and control conditions, which could have occurred if participants within the same cluster (i.e., station/workplace) were individually allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial uses simple randomisation created by computer software. We will employ cluster randomisation. Clusters are defined as individual stations, which vary geographically from each other. Stations will be randomised prior to recruitment commencing using the “randomizeR” package in R. Specifically, a member of the research team will use the cluster_ra() function from the randomizeR package to complete randomisation at the cluster level via the Complete Randomization procedure. Complete Randomization is equivalent to tossing a fair coin for the allocation of each station to either control or intervention arm. R script used to employ the randomisation will be seeded and provided for reproducibility and transparency.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
different groups of participants receive different interventions during the same span of the study. However, control participants receive the intervention (tailored feedback) at the completion of the study (i.e., wait-list control group).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using the n4props() function from the CRTSize package (Rotondi, 2015) in R version 4.0.3 (R Core Team, 2021). The n4props() function calculates the number of subjects required for a cluster randomized trial with a binary outcome. The following parameters were used in the calculation:
- pe = 50%, where pe is the anticipated proportion of individuals with the outcome of interest in the experimental group.
- Pc = 35%, where pc is the anticipated proportion of individuals with the outcome of interest in the control group.
- m = 5, where m is the average cluster size.
- ICC = 5%, where ICC is the anticipated value of the intraclass correlation coefficient.
- AR = 1, where AR is the allocation ration (1 implies an equal number of subjects per treatment and control group).
- Alpha = .05, where alpha is the desired type I error rate.
- Power = 80%, where power is 1 - type II error.
Based on these parameters, a sample size of n = 400 is required (i.e., 40 clusters per group and n = 5 per cluster). Given the outcome of interest will only be analysed in ~30% of the sample (i.e., those who flag as > 18 on the K6), we extrapolated the sample size to n = 1336 (i.e., 134 clusters per group and n = 5 per cluster). Assuming 20% attrition, the final required sample size at baseline is n = 1670 (i.e., 167 clusters per group and n = 5 per cluster).
Data will be analysed using R, SPSS, and/or STATA as required. The primary outcome (help-seeking behaviour) will be analysed using a mixed logistic regression model. P-values will be two-sided with significance set at 0.05. Our a priori formulated primary analyses will compare change over time on overall help-seeking behaviour, and level of new help-seeking behaviour, for participants in the intervention and control groups who scored over 14 on the K6 scale at baseline.
We will also conduct the following analyses:
1. Stratifying the primary analyses by symptom level, comparing the effectiveness of screening on help-seeking between those reporting moderate/subsyndromal distress (i.e., 14-18 on K6) and considerable distress (i.e., above 18 on K6).
2. Analysis of the type of help-seeking behaviours reported, and whether screening is effective at increasing more specialist help seeking (i.e., GP, Psychologist), opposed to generic help-seeking (i.e., EAP service).
We will also analyse the change in the mean K6 score between intervention and control groups across study time-points.
The potential effects of covariates and confounders that differ between groups will be modelled in these analyses. Clustering will also be accounted for as a random factor.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2021
Actual
Date of last participant enrolment
Anticipated
4/04/2022
Actual
Date of last data collection
Anticipated
4/07/2022
Actual
Sample size
Target
1670
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309298 0
Commercial sector/Industry
Name [1] 309298 0
iCare: Insurance and Care NSW
Country [1] 309298 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 310616 0
None
Name [1] 310616 0
Address [1] 310616 0
Country [1] 310616 0
Other collaborator category [1] 281929 0
Government body
Name [1] 281929 0
Fire & Rescue NSW
Address [1] 281929 0
1 Amarina Ave, Greenacre NSW 2190
Country [1] 281929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309129 0
University of New South Wales HREC
Ethics committee address [1] 309129 0
Ethics committee country [1] 309129 0
Australia
Date submitted for ethics approval [1] 309129 0
30/06/2021
Approval date [1] 309129 0
15/10/2021
Ethics approval number [1] 309129 0
HC210527

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

Contacts
Principal investigator
Name 113082 0
Prof Samuel Harvey
Address 113082 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 113082 0
Australia
Phone 113082 0
+61290659180
Fax 113082 0
Email 113082 0
[email protected]
Contact person for public queries
Name 113083 0
Aimee Gayed
Address 113083 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 113083 0
Australia
Phone 113083 0
+61290659043
Fax 113083 0
Email 113083 0
[email protected]
Contact person for scientific queries
Name 113084 0
Aimee Gayed
Address 113084 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 113084 0
Australia
Phone 113084 0
+61290659043
Fax 113084 0
Email 113084 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
We will not be providing IPD, but de-identified group level aggregate data will be made available on a case-by-case basis for all measures. A data sharing agreement will be completed and signed prior to the sharing of data from this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13787Ethical approval    Ethical approval attached. 382506-(Uploaded-26-10-2021-13-37-02)-Study-related document.Pdf



Results publications and other study-related documents

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