Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000207617
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
27/02/2023
Date last updated
27/02/2023
Date data sharing statement initially provided
27/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mental Durability in NSW Police Officers
Scientific title
Feasibility study examining a new de-arousal program for NSW Police Officers
Secondary ID [1] 308985 0
Nil
Universal Trial Number (UTN)
U1111-1288-4283
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Stress - related symptoms 329006 0
Depressive symptoms 329007 0
Anxiety symptoms 329008 0
Pain 329009 0
Sleep problems 329010 0
Condition category
Condition code
Mental Health 325990 325990 0 0
Anxiety
Mental Health 325991 325991 0 0
Depression
Mental Health 325992 325992 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overarching aim of this study is to conduct a pilot feasibility (pre-post design including short-term follow-up) targeting hyperarousal symptoms to assist NSW Police Officers seeking help from the RECON units in NSW for PTSD, anxiety and/or other stress –related disorders, as well as for distress (including depressive symptoms) due to chronic pain.
For the purposes of this project, a new de-arousal therapy manual has recently been developed by psychologists at the RECON unit. The treatment components have been informed by methods that have been found to be beneficial in reducing hyperarousal symptoms including relaxation, exercise and mindfulness strategies. In particular the specific modules of the program include: Coping strategies including cognitive, defusion and behavioural methods, physical activity, breathing and relaxation exercises, sensory grounding skills, mindfulness exercises, self-compassion and gratitude activities, healthy lifestyle education and practice including sleeping patterns, engaging in meaningful activities and hobbies. The program will be delivered on an individual (one-on-one) format in-person. Each therapy session is expected to take 1 hour per week. The therapy modules include interactive activities, including home exercises supplemented by video clips and handouts. Home exercises are expected to take about 5-10 minutes per activity. Participants will be encouraged to practice activities at least several (minimum 2 to 3 times per week and even more regularly as they progress through the program). Home exercises will include such activities as breathing exercises, muscle relaxation practice, and practicing using various coping strategies (including defusion exercises and self-soothing talk). Adherence to the therapy modules and home practice recommendations will be monitored on a weekly basis via an online survey to be completed separately by the participant and therapist.
The specific aim of this study is to test the feasibility and pilot the efficacy of adding this de-arousal program with the traditional therapies currently offered to officers at RECON who present with PTSD, anxiety and/or other stress –related disorders, as well as for chronic pain. These traditional therapies include CBT, Cognitive Processing Therapy, EMDR and physiotherapy. That is, eligible officers will be provided with this new 12 session de-arousal program in combination with any other aforementioned traditional therapies the treating therapist deems suitable for the officer during this 12-week period. Hence, all eligible officers who consent to take part in this study will be offered the de-arousal therapy strategies and encouraged to use these strategies on a weekly basis for 12-weeks whilst they are concurrently receiving any additional evidence-based therapy at the RECON unit.
Although the focus of the 12 therapy sessions will be for participants’ primary problem at referral, sessions may also be tailored to address any crises issues that may arise.
As this is a feasibility study, we will also aim is to monitor (via online self-report measures) the weekly hyperarousal and stress symptoms of officers in conjunction with the specific hyperarousal strategies used as well as any other therapy components administered to determine whether specific hyperarousal strategies are associated with more rapid and /or better treatment gains by the end of the 12 week program.

Given officers will not be precluded from also being offered traditional, evidence-based (cognitive and behavioural based) therapies provided at the RECON clinics, the participating officers’ therapists will also document the type of therapy components received during the course of the 12-week de-arousal program. This data will be taken into account when evaluating and interpreting the study results. For example, we will be able to test whether officers offered CBT components for stress management in conjunction with the de-arousal program report even greater or comparable reductions in symptoms by 12-weeks.

It is noteworthy to highlight that this new de-arousal program is being tested in a real-world clinic context administered by trained clinicians (psychologists and allied mental health experts).
• Summary of Clinician Decision Tree – Ratio of de-arousal strategies covered in each session contingent on primary problem/ at time of referral:
As part of the clinician decision tree, the following ratio of time will be committed to the de-arousal program for each therapy session across the 12 weeks, relative to the traditional, typically CBT-based intervention.
Ratio of de-arousal program and traditional/ CBT (or EMDR) per therapy session
• Anxiety: 60% de-arousal, 40% CBT
• PTSD: 20% de-arousal. 80% EMDR
• Pain: 30% de-arousal, 70% CBT.
• Sleep: 40% de-arousal. 60% CBT
Intervention code [1] 325427 0
Behaviour
Intervention code [2] 325459 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333847 0
Posttraumatic Checklist - 5 (PCL-5) to monitor changes in hyperarousal symptoms.
Timepoint [1] 333847 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Primary outcome [2] 333848 0
Posttraumatic Checklist - 5 (PCL-5) to monitor changes in posttraumatic stress symptoms.
Timepoint [2] 333848 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Primary outcome [3] 333900 0
Depression Anxiety and Stress Scale (DASS-21) to monitor changes in stress symptoms.
Timepoint [3] 333900 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [1] 418460 0
The Osebro Musculoskeletal Pain Questionnaire (OMPQ) - to monitor changes in pain symptoms
Timepoint [1] 418460 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [2] 418461 0
Insomnia Symptom Index (ISI) - to monitor changes in sleep functioning
Timepoint [2] 418461 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [3] 418462 0
International Physical Activity Questionnaire – Shirt Form (IPAQ-SF) to monitor changes in physical activity
Timepoint [3] 418462 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [4] 418463 0
The 36-Item Short Form Survey Instrument (SF-36) - to measure changes in overall quality of life
Timepoint [4] 418463 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [5] 418464 0
WHO- 5 - Well-being Index - to measure changes in positive well-being
Timepoint [5] 418464 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)
Secondary outcome [6] 418465 0
The Credibility/Expectancy Questionnaire (CEQ) to evaluate participants expectations of therapy and how they found the hyperarousal program post-therapy.
Timepoint [6] 418465 0
T1 (at the beginning of therapy) and T2 (12-weeks post-therapy)
Secondary outcome [7] 418663 0
Depression Anxiety and Stress Scale (DASS-21) to monitor changes in depression symptoms.
Timepoint [7] 418663 0
1) Pre-Post Therapy (12-weeks) (T1 to T2)
2) 1-month follow-up (T3)
3) 3 months follow-up (T4)

Eligibility
Key inclusion criteria
Any officer referred (including self-referrals) to the NSW RECON clinics for work-related stressors, including self-reporting poor mental health, fear or avoidance of work cues due to stress and fear of injury, and which score at minimum:-
1) mild levels of anxiety and stress symptoms on the DASS (Depression Anxiety and Stress Scale: DASS21); and
2) present with at least moderate sleep problems (Insomnia Severity Index; ISI); and/ or
3) score above 105 on the OMPQ (Orebro Musculoskeletal Pain Questionnaire) will be eligible.
NB- The DASS, ISI and OMPQ is routinely used as a screening measure at RECON clinics.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Officers will not be eligible if they only score uniformly in the normal range on all three measures: the DASS-21, ISI and OMPQ. Any person who scores in the clinical range only on the DASS-21 depression subscale and does not report any of the following symptoms - anxiety, stress, sleep or pain disturbances will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot feasibility trial. The aim is to recruit at least 40 participants.
1) For the quantitative data – to test the main study hypotheses, paired t-tests and repeated measures will be used. Sub-group analyses will also be examined using repeated measures ANCOVAs to determine whether findings may also differ via sex, and therapy compliance (i.e. participants who complete all 12 sessions versus those who complete less than 8 sessions), whilst controlling for any relevant covariates (e.g., age).
If some of the data variables are not normally distributed, non-parametric statistics will be conducted, such as Wilcoxon signed-Rank Test.

2) Feasibility data – narrative written responses to the feasibility questions will be coded and where relevant (and if sufficient participant data is available) will also be included in additional quantitative analyses to determine whether specific strategies reported to be highly used are related to better outcomes on the primary and secondary measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
30/08/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39527 0
2000 - Sydney
Recruitment postcode(s) [2] 39528 0
2170 - Moorebank
Recruitment postcode(s) [3] 39529 0
2322 - Beresfield

Funding & Sponsors
Funding source category [1] 313198 0
Government body
Name [1] 313198 0
State Insurance Regulatory Authority (SIRA)
Country [1] 313198 0
Australia
Primary sponsor type
Government body
Name
NSW Police Force
Address
Locked Bag 5102
Parramatta, NSW 2124
Country
Australia
Secondary sponsor category [1] 314914 0
University
Name [1] 314914 0
Macquarie University
Address [1] 314914 0
Ryde Campus
Building AHH L2
Ryde 2109 NSW
Country [1] 314914 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312430 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 312430 0
Ethics committee country [1] 312430 0
Australia
Date submitted for ethics approval [1] 312430 0
15/05/2022
Approval date [1] 312430 0
01/07/2022
Ethics approval number [1] 312430 0
520221170439623

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

Contacts
Principal investigator
Name 124638 0
Mr Robert McCullagh
Address 124638 0
NSW Police
1 Charlies St, Parramatta, NSW, 2150
Country 124638 0
Australia
Phone 124638 0
+61 2 9265 4562
Fax 124638 0
Email 124638 0
[email protected]
Contact person for public queries
Name 124639 0
Robert McCullagh
Address 124639 0
NSW Police
1 Charlies St, Parramatta, NSW, 2150
Country 124639 0
Australia
Phone 124639 0
+61 2 131 444
Fax 124639 0
Email 124639 0
[email protected]
Contact person for scientific queries
Name 124640 0
Maria Kangas
Address 124640 0
Macquarie University
AHH L2 (North) Rm:2.684
NSW 2109, Australia
Country 124640 0
Australia
Phone 124640 0
+61 2 98508599
Fax 124640 0
Email 124640 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
This is a pilot feasibility trial conducted in a clinical context within the NSW Police Force Reconnect Units. Data has not been approved to be shared for this trial.


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.