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Trial registered on ANZCTR


Registration number
ACTRN12620000277943
Ethics application status
Approved
Date submitted
17/02/2020
Date registered
3/03/2020
Date last updated
19/11/2021
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Attention Training in Police Officers
Scientific title
A randomised controlled trial to evaluate the effect of attention training on situational awareness and post-traumatic stress in police officers
Secondary ID [1] 300566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 316300 0
Post-traumatic stress 316443 0
Condition category
Condition code
Mental Health 314567 314567 0 0
Anxiety
Mental Health 314568 314568 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attention Control Training aims to improve people's capacity to control their attentional focus. It involves once-weekly for 4 weeks and comprises 7 minutes per session. It will be administered via computer and is self-administered in police stations. This computer session requires participants to indicate on a keyboard the location of a probe stimulus. Prior to each stimulus an angry or neutral face appeared on the computer screen, and the probe appears in the position of the angry and neutral face with equal probability. Participants are required to indicate using the keyboard the location of the probe. Adherence to the program is automatically checked by the computer program assessing accuracy of choosing the correct key on the keyboard. The duration of the study for any participant will conclude after a follow-up assessment 12 weeks after the program, resulting in participation duration of 16 weeks.
Intervention code [1] 316870 0
Behaviour
Comparator / control treatment
The comparison condition occurs once-weekly for 4 weeks and comprises 7 minutes per session. It will be administered via computer and is self-administered in police stations. This computer session requires participants to indicate on a keyboard the location of a probe stimulus. Prior to each stimulus an angry or neutral face appeared on the computer screen, and the probe always appear in the position of the neutral face. Participants are required to indicate using the keyboard the location of the probe. Adherence to the program is automatically checked by the computer program assessing accuracy of choosing the correct key on the keyboard. The duration of the study for any participant will conclude after a follow-up assessment 12 weeks after the program, resulting in participation duration of 16 weeks.
Control group
Active

Outcomes
Primary outcome [1] 322893 0
Posttraumatic stress as measured by the PTSD Checklist.
Timepoint [1] 322893 0
Baseline (week 1), post-program (week 4), and follow-up (week 16). The primary endpoint is the post-program assessment.
Secondary outcome [1] 380161 0
Situation awareness as measured by a self-report scale specifically designed for this study.
Timepoint [1] 380161 0
Baseline (week 1), post-program (week 4), and follow-up (week 16)

Eligibility
Key inclusion criteria
Member of NSW Police Force
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
A computer program randomly allocates participants to the Attention Control Training condition or comparator condition via the software program when participants enrol. This will be done in a way in which no personnel will influence which participant is allocated to a specific condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to conditions on a 1:1 basis via simple randomisation by a computer software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is powered to detect significant differences between treatment arms. Analyses of the relative efficacy of the Attention Control Training and comparator programs will be evaluated using linear mixed models analysis. The Level 1 model will represent within-participant change over time, and the Level 2 model will predict variation in within-participant change over time and encompass between-participant variables (treatment condition). Primary outcome will be the PTSD Checklist and Situational Awareness Scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2020
Actual
30/07/2020
Date of last participant enrolment
Anticipated
29/06/2020
Actual
24/12/2020
Date of last data collection
Anticipated
26/10/2020
Actual
23/04/2021
Sample size
Target
400
Accrual to date
Final
470
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304984 0
Commercial sector/Industry
Name [1] 304984 0
TAL Insurance
Country [1] 304984 0
Australia
Primary sponsor type
Government body
Name
NSW Police Force
Address
151-241 Goulburn St, Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 305345 0
University
Name [1] 305345 0
UNSW Sydney
Address [1] 305345 0
Sydney, NSW, 2052
Country [1] 305345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305387 0
UNSW Human Research Ethics Committee Panel C
Ethics committee address [1] 305387 0
Ethics committee country [1] 305387 0
Australia
Date submitted for ethics approval [1] 305387 0
17/02/2020
Approval date [1] 305387 0
21/02/2020
Ethics approval number [1] 305387 0

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

Contacts
Principal investigator
Name 100206 0
Prof Richard Bryant
Address 100206 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100206 0
Australia
Phone 100206 0
+61293853640
Fax 100206 0
+61 293853641
Email 100206 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 100207 0
Richard Bryant
Address 100207 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100207 0
Australia
Phone 100207 0
+61293853640
Fax 100207 0
+61 293853641
Email 100207 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 100208 0
Richard Bryant
Address 100208 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100208 0
Australia
Phone 100208 0
+61293853640
Fax 100208 0
+61 293853641
Email 100208 0
r.bryant@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD data will be shared after all data is de-identified, and all participant data will be based on data used in published results.
When will data be available (start and end dates)?
Upon publication of the results. No end date is specified for sharing of data.
Available to whom?
Researchers conducting meta-analyses on attention control training.
Available for what types of analyses?
Item-level meta-analyses
How or where can data be obtained?
Emailing Professor Richard Bryant (r.bryant@unsw.edu.au)


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.