Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001442897
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
25/10/2021
Date last updated
28/09/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an Augmented Psychological Treatment on Posttraumatic Stress Disorder (PTSD) and Depression in Emergency Service Personnel
Scientific title
Randomised Controlled Trial of a Standard Cognitive Behavioural Treatment versus Augmented Cognitive Behavioural Treatment on PTSD and Depression in Emergency Service Personnel
Secondary ID [1] 305399 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 323756 0
Depression 323757 0
Condition category
Condition code
Mental Health 321279 321279 0 0
Depression
Mental Health 321280 321280 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial that were designed specifically for this trial. Arm 1: Cognitive Behaviour Therapy. Arm 2: Augmented Cognitive Behaviour Therapy. Cognitive Behaviour Therapy is administered on an individual basis on a once-weekly basis by a clinical psychologist either face-to-face or remotely via Zoom. Therapy comprises individual 60-minute sessions administered over 12 weeks. The intervention instructs participants on the following stress coping strategies: psychoeducation, anxiety reduction, exposure to trauma memories, and discussion of trauma memories, and relapse prevention. Treatment adherence will be assessed by checklist completed by therapists. The duration of the study for any participant will conclude after a 2-year follow-up assessment, resulting in participation duration of 121 weeks.
Intervention code [1] 321811 0
Behaviour
Intervention code [2] 321812 0
Treatment: Other
Comparator / control treatment
Augmented Cognitive Behaviour Therapy is administered on an individual basis on a once-weekly basis by a clinical psychologist either face-to-face or remotely via Zoom. Therapy comprises individual 60-minute sessions administered over 12 weeks. The intervention instructs participants the following stress coping strategies: psychoeducation, anxiety reduction, exposure to trauma memories, and discussion of trauma memories, relapse prevention, and teaching strategies to retrieve positive personal memories. The difference between the two arms is the inclusion of strategies to retrieve positive memories in the comparator condition. Treatment adherence will be assessed by checklist completed by therapists. The duration of the study for any participant will conclude after a 2-year follow-up assessment, resulting in participation duration of 121 weeks.
Control group
Active

Outcomes
Primary outcome [1] 329062 0
Posttraumatic stress disorder as measured by the Clinician Administered PTSD Scale.
Timepoint [1] 329062 0
Pretreatment (week 0), posttreatment (week 13), primary follow-up (week 39, primary endpoint), additional follow-up (week 121).
Secondary outcome [1] 401329 0
Depression as measured by the Beck Depression Inventory.
Timepoint [1] 401329 0
Pretreatment (week 0), posttreatment (week 13), primary follow-up (week 39, primary endpoint), additional follow-up (week 121).
Secondary outcome [2] 401330 0
Maladaptive appraisals as measured by the Posttraumatic Cognitive Inventory.
Timepoint [2] 401330 0
Pretreatment (week 0), posttreatment (week 13), primary follow-up (week 39, primary endpoint), additional follow-up (week 121).
Secondary outcome [3] 401331 0
Quality of life as measured by the WHO Quality of Life scale.
Timepoint [3] 401331 0
Pretreatment (week 0), posttreatment (week 13), primary follow-up (week 39, primary endpoint), additional follow-up (week 121).
Secondary outcome [4] 401998 0
Alcohol use as measured by the Alcohol Use Disorder Identification Test
Timepoint [4] 401998 0
Pretreatment (week 0), posttreatment (week 13), primary follow-up (week 39, primary endpoint), additional follow-up (week 121).

Eligibility
Key inclusion criteria
Meet criteria for PTSD as defined by DSM-5
Aged at least 18 years
Current or former member of Emergency Service Personnel
Sufficient English proficiency
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current psychosis
Imminent suicidal risk
Current substance dependence

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adults meeting criteria for PTSD. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the trial 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
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 follow-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 Clinician Administered PTSD Scale (CAPS). The primary outcome timepoint will be the 6 months assessment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2022
Actual
10/12/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
28/11/2022
Date of last data collection
Anticipated
10/03/2025
Actual
11/08/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309762 0
Government body
Name [1] 309762 0
National Health and Medical Research Council (NHMRC)
Country [1] 309762 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 310786 0
None
Name [1] 310786 0
NA
Address [1] 310786 0
NA
Country [1] 310786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309519 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309519 0
Ethics committee country [1] 309519 0
Australia
Date submitted for ethics approval [1] 309519 0
02/10/2021
Approval date [1] 309519 0
09/12/2021
Ethics approval number [1] 309519 0
HC210804

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

Contacts
Principal investigator
Name 114434 0
Prof Richard Bryant
Address 114434 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 114434 0
Australia
Phone 114434 0
+61405375874
Fax 114434 0
Email 114434 0
[email protected]
Contact person for public queries
Name 114435 0
Richard Bryant
Address 114435 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 114435 0
Australia
Phone 114435 0
+61405375874
Fax 114435 0
Email 114435 0
[email protected]
Contact person for scientific queries
Name 114436 0
Richard Bryant
Address 114436 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 114436 0
Australia
Phone 114436 0
+61405375874
Fax 114436 0
Email 114436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual participant data and related data dictionaries are available
When will data be available (start and end dates)?
Data will be available following publication of the study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct re-analyses of the data after approval from the Chief Investigator
Available for what types of analyses?
Meta-analyses or re-analyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: [email protected]).


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.