Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000029796
Ethics application status
Approved
Date submitted
4/12/2021
Date registered
14/01/2022
Date last updated
27/02/2023
Date data sharing statement initially provided
14/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Group Resilience Program on Psychological DIstress in Corrections Officers
Scientific title
Randomised Controlled Trial of a Resilience Program versus Repeated Assessment on Psychological DIstress in Corrections Officers
Secondary ID [1] 305908 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 324479 0
Depression 324480 0
Absenteeism 324481 0
Condition category
Condition code
Mental Health 321963 321963 0 0
Anxiety
Mental Health 321964 321964 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Resilience Program. Arm 2: Repeated Assessments. The Resilience Program is an adaptation of an evidence-based psychological intervention, Problem Management Plus. The Resilience program is administered face-to-face over two x 2-hour group sessions that are administered one month apart. Sessions are administered by clinical psychologists to groups of 10-15 people. The clinical psychologist will teach the following stress coping strategies: anxiety reduction, problem solving, behavioral activation, and accessing social support. This will occur will via educational sessions and group discussions. Participants will also be instructed to download an app (the Headgear app) that provides additional skills in anxiety reduction, mindfulness, and behavioural activation. This app will guide participants in these skills via instructional prompts and will be available to participants to use on an ongoing basis for the duration of the study. The app will be available for participants as an ongoing self-help aid to be used at the participant's discretion. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 30 weeks. Adherence will be assessed by monitoring participants' attendance at each session via a checklist maintained by the clinical psychologist.
Intervention code [1] 322304 0
Prevention
Intervention code [2] 322305 0
Behaviour
Comparator / control treatment
The Repeated Assessment arm comprises the same outcome assessments as those administered in the Resilience Program. Participants will receive a baseline assessment, and the outcome assessments at one month later, and 6 months. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 30 weeks.
Control group
Active

Outcomes
Primary outcome [1] 329716 0
Psychological distress as measured by the Kessler 10 scale.
Timepoint [1] 329716 0
Pretreatment (week 0), posttreatment (week 5), and primary follow-up (week 30, primary timepoint).
Secondary outcome [1] 403576 0
Pretreatment (week 0), posttreatment (week 5), and primary follow-up (week 30, primary timepoint).
Timepoint [1] 403576 0
Pretreatment (week 0), posttreatment (week 5), and primary follow-up (week 30, primary timepoint).
Secondary outcome [2] 403577 0
Pretreatment (week 0), posttreatment (week 5), and primary follow-up (week 30, primary timepoint).
Timepoint [2] 403577 0
Pretreatment (week 0), posttreatment (week 5), and primary follow-up (week 30, primary timepoint).

Eligibility
Key inclusion criteria

Employee of Corrections NSW
Minimum 18 years of age
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)
Participants agreeing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 24, hierarchical linear mixed models (HLM) will be used to study differential effects of each treatment condition because this method effectively handles missing data by calculating estimates of trajectories. For the folow-up analyses between the two conditions, analyses will focus on linear time effects, treatment conditions, and interactions. Fixed effects parameters were tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the K10. The primary outcome timepoint will be the 6 months assessment.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/03/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
11/07/2022
Actual
5/10/2022
Date of last data collection
Anticipated
7/10/2023
Actual
Sample size
Target
600
Accrual to date
Final
585
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310258 0
Charities/Societies/Foundations
Name [1] 310258 0
icare NSW
Country [1] 310258 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 311366 0
None
Name [1] 311366 0
Address [1] 311366 0
Country [1] 311366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309930 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309930 0
Ethics committee country [1] 309930 0
Australia
Date submitted for ethics approval [1] 309930 0
18/01/2022
Approval date [1] 309930 0
12/05/2022
Ethics approval number [1] 309930 0

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

Contacts
Principal investigator
Name 115878 0
Prof Richard Bryant
Address 115878 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115878 0
Australia
Phone 115878 0
+61405375874
Fax 115878 0
Email 115878 0
[email protected]
Contact person for public queries
Name 115879 0
Richard Bryant
Address 115879 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115879 0
Australia
Phone 115879 0
+61405375874
Fax 115879 0
Email 115879 0
[email protected]
Contact person for scientific queries
Name 115880 0
Richard Bryant
Address 115880 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115880 0
Australia
Phone 115880 0
+61405375874
Fax 115880 0
Email 115880 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
These data are sensitive to nature of Corrections Services privacy issues, and so cannot be shared.


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
EmbaseStudy protocol for a controlled trial of a resilience program on psychological distress in correctional officers in Australia.2023https://dx.doi.org/10.1186/s12888-023-04592-4
N.B. These documents automatically identified may not have been verified by the study sponsor.