Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001004459
Ethics application status
Approved
Date submitted
24/07/2016
Date registered
29/07/2016
Date last updated
27/10/2021
Date data sharing statement initially provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title

Trial of Psychotherapy for Posttraumatic Stress Disorder in Emergency Service Personnel
Scientific title
Randomised Controlled Trial of Cognitive Behaviour Therapy for Posttraumatic Stress Disorder (PTSD) in Emergency Service Personnel
Secondary ID [1] 289743 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 299591 0
Condition category
Condition code
Mental Health 299560 299560 0 0
Anxiety
Mental Health 299618 299618 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Cognitive Behaviour Therapy (CBT). Arm 2: Modified Cognitive Behaviour Therapy (MCBT). CBT is administered by Clinical Psychologists once-weekly over 12 weeks on an individual 60 minute basis. Cognitive Behaviour Therapy includes psychoeducation, exposure to trauma memories, and cognitive restructuring of themes related to traumatic experiences. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Intervention code [1] 295381 0
Behaviour
Comparator / control treatment
MCBT is administered by Clinical Psychologists once-weekly over 12 weeks on an individual 60 minute basis. MCBT includes psychoeducation, exposure to trauma memories, cognitive restructuring of themes related to traumatic experiences, and strategies in management of perseverative memories. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Control group
Active

Outcomes
Primary outcome [1] 299036 0
Posttraumatic stress disorder, as measured by the PTSD Clinician Administered Scale.
Timepoint [1] 299036 0
Pretreatment (week 0), posttreatment (week 12), 6-Month Follow-up (week 38)
Secondary outcome [1] 325937 0
Depression as measured by the Beck Depression Inventory
Timepoint [1] 325937 0
Pretreatment (week 0), posttreatment (week 12), 6-Month Follow-up (week 38)
Secondary outcome [2] 326114 0
Posttraumatic Cognitions Inventory (PTCI)
Timepoint [2] 326114 0
Pretreatment (week 0), posttreatment (week 12), 6-Month Follow-up (week 38)

Eligibility
Key inclusion criteria
Emergency service personnel who meet the DSM-5 criteria diagnostic criteria for posttraumatic stress disorder (as measured on the PTSD Clinician Administered Scale), including (a) exposure to a trauma events, (b) re-experiencing, (c) avoidance, (d) alterations in mood and cognition, and (e) arousal..
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) inadequate comprehension of English, (b) imminent suicidal intent, or (c) psychosis

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 emergency service personnel who respond to advertising, and who indicate meeting PTSD criteria. This was the initial recruitment procedure, and inclusion criteria included emergency service personnel prior to initial enrolment. Any eligible emergency service personnel wishing 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 distant from the treatment 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. This process was determined prior to enrollment of the first patient.
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
We calculate needing 50 patients per cell with power of 70%, to obtain an effect-size at .7 to detect a difference of 8 points on the Clinician-Administered PTSD Scale. The primary focus of analyses will be on intent-to-treat analyses. Using SPSS version 23, hierarchical linear models (HLM) will be used to study differential effects of each treatment condition because to allow the number of observations to vary between participants, which effectively handles missing data. Linear and quadratic time effects, treatment condition, and their interaction are in the autoregressive models. Fixed effects parameters will be tested with the Wald test (t-test) and 95% confidence intervals. Effect sizes will be calculated using recommendations for multilevel models, with the formula: d=B*time _ /raw score of pretreatment standard deviation. Analyses focus on the primary (PTSD Scale) and secondary (BDI, PTCI) outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
7/08/2017
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
100
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20952 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 13662 0
2052 - Unsw Sydney
Recruitment postcode(s) [2] 35769 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294125 0
Government body
Name [1] 294125 0
National Health and Medical Research Council (NHMRC)
Country [1] 294125 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 292957 0
None
Name [1] 292957 0
Address [1] 292957 0
Country [1] 292957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295531 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 295531 0
Ethics committee country [1] 295531 0
Australia
Date submitted for ethics approval [1] 295531 0
12/07/2016
Approval date [1] 295531 0
27/07/2017
Ethics approval number [1] 295531 0
HC16601

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3203 3203 0 0
http://www.anzctr.org.au/AnzctrAttachments/371147-Cops Final Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 67646 0
Prof Richard Bryant
Address 67646 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 67646 0
Australia
Phone 67646 0
+61293853640
Fax 67646 0
+61293853641
Email 67646 0
[email protected]
Contact person for public queries
Name 67647 0
Richard Bryant
Address 67647 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 67647 0
Australia
Phone 67647 0
+61293853640
Fax 67647 0
+61293853641
Email 67647 0
[email protected]
Contact person for scientific queries
Name 67648 0
Richard Bryant
Address 67648 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 67648 0
Australia
Phone 67648 0
+61293853640
Fax 67648 0
+61293853641
Email 67648 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?
Summary clinical outcomes
When will data be available (start and end dates)?
Once major trial is published
Available to whom?
Any researchers wishing to undertake IDP analyses.
Available for what types of analyses?
IDP and meta-analyses
How or where can data be obtained?
Data can be accessed by emailing the Principal Investigator ([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.