ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Posttraumatic stress disorder

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

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]

Posttraumatic stress disorder, as measured by the PTSD Clinician Administered Scale.

Timepoint [1]

Pretreatment (week 0), posttreatment (week 12), 6-Month Follow-up (week 38)

Secondary outcome [1]

Depression as measured by the Beck Depression Inventory

Timepoint [1]

Pretreatment (week 0), posttreatment (week 12), 6-Month Follow-up (week 38)

Secondary outcome [2]

Posttraumatic Cognitions Inventory (PTCI)

Timepoint [2]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 1, 16 Marcus Clarke Street, Canberra, ACT, 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/07/2016

Approval date [1]

27/07/2017

Ethics approval number [1]

HC16601

Summary

Brief summary

Emergency service personnel 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 Emergency service personnel 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 emergency service personnel. In the absence of evidence, there is a critical need for controlled trials of optimal interventions to assist emergency service personnel with PTSD. This study conducts a randomized controlled trial of cognitive behavior therapy for (CBT) in emergency service personnel to determine the optimal means to enhance treatment response.. This study will provide the much-needed evidence to shape policy and practice.
Emergency service personnel 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. Emergency service personnel will be randomised to either CBT, which involves focusing on reliving trauma memories, as well as teaching strategies to reframe common maladaptive appraisals. Alternately, emergency service personnel will be randomised to a modified version of CBT that will also include depression treatment strategies. Participants will be assessed prior to treatment, immediately following treatment, and again 6 months later. These data will provide much-needed evidence for treating Emergency service personnel  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

Attachments [1]

http://www.anzctr.org.au/AnzctrAttachments/371147-Cops Final Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Richard Bryant

Address

School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW

Country

Australia

Phone

+61293853640

Fax

+61293853641

r.bryant@unsw.edu.au

Contact person for public queries

Name

Richard Bryant

Address

School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW

Country

Australia

Phone

+61293853640

Fax

+61293853641

r.bryant@unsw.edu.au

Contact person for scientific queries

Name

Richard Bryant

Address

School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW

Country

Australia

Phone

+61293853640

Fax

+61293853641

r.bryant@unsw.edu.au

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 (r.bryant@unsw.edu.au)

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.

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