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Trial registered on ANZCTR


Registration number
ACTRN12616001004459p
Ethics application status
Submitted, not yet approved
Date submitted
24/07/2016
Date registered
29/07/2016
Date last updated
29/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behaviour Therapy for Posttraumatic Stress Disorder (PTSD) in Police
Scientific title
Randomised Controlled Trial of the Effect of Cognitive Behaviour Therapy on Posttraumatic Stress Disorder in Police
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 emotion management. 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
Police 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
Gender
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 police who respond to advertising, and who indicate meeting PTSD criteria. Participants 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)
Randomization will be conducted by a process of minmization stratified on severity of PTSD levels.
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
Not yet 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] 13662 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 294125 0
Government body
Name [1] 294125 0
National Health and Medical Research Council (NHMRC)
Address [1] 294125 0
Level 1, 16 Marcus Clarke Street, Canberra, ACT, 2601
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
Submitted, not yet approved
Ethics committee name [1] 295531 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 295531 0
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Ethics committee country [1] 295531 0
Australia
Date submitted for ethics approval [1] 295531 0
23/07/2016
Approval date [1] 295531 0
Ethics approval number [1] 295531 0

Summary
Brief summary
Police are exposed to major stressors in the line of their work. They are at elevated risk of developing posttraumatic stress disorder (PTSD), with approximately 10% of police suffering the condition. The nature and pattern of trauma exposure amongst police is different to those experienced by other populations. They suffer repeated exposure to trauma, may witness individuals who have been badly hurt, directly threatened themselves or be required to seriously wound others. Hence, their response to trauma is often anger and guilt, rather than the fear often described by members of the general population exposed to one off, trauma. There is currently limited evidence of optimal treatment of PTSD in police. In the absence of evidence, there is a critical need for controlled trials of optimal interventions to assist police with PTSD. This study conducts a randomized controlled trial of cognitive behavior therapy for (CBT) police to determine the optimal means to enhance treatment response.. This study will provide the much-needed evidence to shape policy and practice.
Police with PTSD will be randomized to receive either 12 sessions of cognitive behaviour therapy delivered by clinical psychologists Treatment is based on 12 weekly 1-hour sessions. Police will be randomised to either CBT, which involves focusing on reliving trauma memories, as well as teaching strategies to reframe common maladaptive appraisals. Alternately, police will be randomised to a modified version of CBT that will also include depression treatment strategies. Police will be assessed prior to treatment, immediately following treatment, and again 6 months later. These data will provide much-needed evidence for treating police officers and provide police, fire-fighting, and ambulance services direction on how to limit PTSD in their organisations.
Trial website
Trial related presentations / publications
Public notes

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
r.bryant@unsw.edu.au
Contact person for public queries
Name 67647 0
Prof 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
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 67648 0
Prof 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
r.bryant@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results