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Trial registered on ANZCTR


Registration number
ACTRN12609000324213
Ethics application status
Approved
Date submitted
27/04/2009
Date registered
21/05/2009
Date last updated
17/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized controlled trial of cognitive behaviour therapy for reduction of posttraumatic stress disorder symptoms in emergency service personnel
Scientific title
Randomized controlled trial of cognitive behaviour therapy with and without prolonged exposure for reduction of posttraumatic stress disorder symptoms emergency service personnel
Secondary ID [1] 292561 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 4672 0
Condition category
Condition code
Mental Health 4978 4978 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy with long prolonged exposure (CBT/Long) involves 12 once-weekly 90-minute sessions of individual therapy over 12 weeks. The therapy includes 4 sessions of emotion regulation skills training, 6 sessions of cognitive reframing and reliving trauma memories (for 40 minutes duration) and reappraisal of beliefs about traumatic experiences, and 1 sessions of relapse prevention.
Intervention code [1] 4434 0
Treatment: Other
Comparator / control treatment
Cognitive behaviour therapy with brief prolonged exposure (CBT/Brief) involves 12 once-weekly 60-minute sessions of individual therapy over 12 weeks. The therapy includes 4 sessions of emotion regulation skills training, 6 sessions of cognitive reframing and reliving trauma memories (for 10 minutes duration) and reappraisal of beliefs about traumatic experiences, and 1 sessions of relapse prevention.

In addition, participants will be randomized to wait-list for a period of 3 months after which they will be randomized to either CBT/Long or CBT/Brief.
Control group
Active

Outcomes
Primary outcome [1] 5825 0
Posttraumatic stress disorder symptoms assessed by the Clinician-Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 5825 0
Pretreatment, posttreatment, 6-month follow-up
Secondary outcome [1] 241830 0
Depression measured by the Beck Depression Inventory
Timepoint [1] 241830 0
Pretreatment, posttreatment, 6-month follow-up (primary end-point), 2-year follow-up (secondary endpoint)
Secondary outcome [2] 337494 0
Posttraumatic appraisals as measured by the Posttraumatic Cognitions Inventory.
Timepoint [2] 337494 0
Pretreatment, posttreatment, 6-month follow-up (primary end-point), 2-year follow-up (secondary endpoint)
Secondary outcome [3] 337495 0
Functional impairment as measured by the World Health Organization Quality of Life scale.
Timepoint [3] 337495 0
Pretreatment, posttreatment, 6-month follow-up (primary end-point), 2-year follow-up (secondary endpoint)
Secondary outcome [4] 337496 0
Alcohol use as assessed by the Alcohol Use Identification Test (AUDIT).
Timepoint [4] 337496 0
Pretreatment, posttreatment, 6-month follow-up (primary end-point), 2-year follow-up (secondary endpoint)

Eligibility
Key inclusion criteria
(1) Active or retired emergency service personnel (including police, firefighter, paramedic), (2) exposure to trauma, (3) meet criteria for posttraumatic stress disorder
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal risk, psychotic, substance dependent

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 treatment seeking emergency service personnel attending the UNSW Traumatic Stress Clinic. Participants will be randomly assigned according to a random numbers system administered by an individual who is independent of the study and who works at the University of New South Wales
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratifed by gender and posttraumatic stress disorder severity.
Masking / blinding
Who is / are masked / blinded?



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. HLM involves a multilevel organization that includes fixed and random intercepts and slopes. Linear time effects, treatment condition, and their interaction were in the autoregressive models, which provides an index of the relative effects of the treatments. Fixed effects parameters were tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Analyses focus on the primary (CAPS) and secondary (BDI, WHOQOL, Audit, PTCI) outcomes, with the primary outcome point being the 6-month follow-up. Subsequent secondary outcome point will be a 2-year follow-up. The proportion of police who no longer met criteria for PTSD (on treatment completers) will also be calculated.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16780 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 4854 0
Government body
Name [1] 4854 0
National Health and Medical Research Council
Address [1] 4854 0
GPO Box 1421 Canberra ACT 2601
Country [1] 4854 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 4392 0
Hospital
Name [1] 4392 0
Westmead Hospital
Address [1] 4392 0
Westmead Hospital, O'Brien's Road, Westmead, NSW, 2145
Country [1] 4392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6912 0
Ethics committee address [1] 6912 0
Ethics committee country [1] 6912 0
Date submitted for ethics approval [1] 6912 0
04/08/2010
Approval date [1] 6912 0
03/06/2011
Ethics approval number [1] 6912 0

Summary
Brief summary
This trial will randomly allocate participants with PTSD to either cognitive behaviour therapy with long prolonged exposure (CBT/Long) or cognitive behaviour therapy with brief exposure (CBT/Brief) or Wait-List. After the Wait-List participants were assessed after 3 months, they were randomly assessed to either CBT/Long or CBT/Brief.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29536 0
Prof Richard Bryant
Address 29536 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052
Country 29536 0
Australia
Phone 29536 0
61293853640
Fax 29536 0
61293853641
Email 29536 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 12783 0
Prof Professor Richard Bryant
Address 12783 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052
Country 12783 0
Australia
Phone 12783 0
+61 2 93853640
Fax 12783 0
+61 2 93853641
Email 12783 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 3711 0
Prof Professor Richard Bryant
Address 3711 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052
Country 3711 0
Australia
Phone 3711 0
+61 2 93853640
Fax 3711 0
+61 2 93853641
Email 3711 0
r.bryant@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary