Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001083886
Ethics application status
Approved
Date submitted
18/06/2021
Date registered
16/08/2021
Date last updated
11/07/2024
Date data sharing statement initially provided
16/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivery of an evidence-based therapy for posttraumatic stress disorder (PTSD): A combined analysis of clinical effectiveness and associated economic benefits.
Scientific title
Delivery of Cognitive Processing Therapy (CPT) for posttraumatic stress disorder (PTSD): A combined analysis of clinical effectiveness and associated economic benefits.
Secondary ID [1] 303978 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 321592 0
Condition category
Condition code
Mental Health 319333 319333 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project represents an open trial, aiming to examine the benefits to society of providing effective PTSD therapy to clients (i.e., does reducing PTSD have economic and social benefits) while also examining the cost-benefit ratio of training costs and client outcomes. Additionally this project will explore clinician’s beliefs surrounding evidence-based practices, in order to better understand the barriers preventing the implementation of EBPs in trauma treatment.

There are two components to this project, first, approximately 30 clinicians will receive training in an evidence-based trauma-focused therapy known as Cognitive Processing Therapy (CPT). Second, each clinician will then engage with 5-10 clients over the course of the study and provide CPT.

30 clinicians across multiple sites and services in Adelaide (e.g., SA health sites) will receive CPT training. In this study ‘clinicians’ encompass psychologists, social workers, counsellors or other suitable health professionals. Clinicians first undertake an online training course in CPT (taking approximately 13hrs), followed by a 2-day workshop in Cognitive Processing Therapy (CPT), conducted by Prof Reg Nixon. Clinicians will complete the online training 1-2 weeks before attending the workshop. Following the training, clinicians receive 6-months of weekly (1 hour) expert CPT consultation, from two Clinical Psychologists who are certified CPT trainers. This is conducted via Zoom in groups of up to 10 clinicians.

Delivery of CPT sessions will start following the 2-day workshop, with weekly expert CPT consultations occurring concurrently for 6-months. Clinicians will continue to provide CPT to clients presenting at their service for a further 6-months. Potential clients will already be seeking mental health treatment at the sites involved in this study. Each site has its own routine clinical intake process and clients identified as potentially being eligible through these processes will be given the opportunity to participate in the study (and will complete measures to establish eligibility). Eligible clients will then complete pre-treatment assessment via a Qualtrics survey. As this is an effectiveness trial (done in routine mental health setting), we are not doing formal fidelity adherence. However, clinicians will indicate what is done during therapy in their routine case notes and additionally, monitoring occurs during consultation (supervision) in the first 6-months.

CPT is an evidence-based cognitive behavioural therapy for PTSD developed by Resick, Monsoon and Chard (2017). In the current study, participants will receive individually administered CPT which involves weekly, 60-minute sessions (face to face, or via tele-health if required). CPT duration is usually between 8 to 18 weeks depending on a client's individual needs. In determining how many sessions are required, Clinicians will use their clinical judgment which will be informed by weekly monitoring of PTSD symptoms. Regardless of how many sessions are administered all key CPT components will be covered, some clients may just need more sessions on particular components. Initial sessions provide a rationale for the approach, and psychoeducation about PTSD. Participants are asked to write an impact statement about how the trauma has impacted their life and beliefs about their self, others and the world. Client’s will complete the impact statements in their own time and clients can be quite variable in the length of time they take to complete these impact statements. Subsequent sessions then focus upon learning to identify and label thoughts and feelings, and challenging unhelpful automatic thoughts through Socratic questioning. Therapist works with the participant to develop strategies for generating more useful and helpful thinking patterns. The final sessions focus on maladaptive beliefs surrounding safety, trust, power, esteem, intimacy (domains that are often impacted by PTSD). Before the final session of CPT, participants write a new impact statement which typically reflects treatments gains, and relapse prevention is discussed.


Intervention code [1] 320298 0
Treatment: Other
Intervention code [2] 321103 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327332 0
Quality of life as measured by the Assessment of Quality of Life (AQoL-8D) . Used to calculate Quality Adjusted Life Years (QALYS) which is used to facilitate the economic evaluation.
Timepoint [1] 327332 0
1 week pre-treatment assessment, 1 week post-treatment completion (primary time point), 6 months post-treatment completion
Primary outcome [2] 327333 0
Severity of PTSD using the Posttraumatic stress disorder checklist (PCL-5).
Timepoint [2] 327333 0
1 week pre-treatment assessment, at the beginning of each weekly CTP session, 1 week post-treatment completion (primary time point), 6 months post-treatment completion
Primary outcome [3] 327837 0
Healthcare utilisation data via Medical Benefits Schedule (MBS) Services Australia
Timepoint [3] 327837 0
12 months prior to clients starting therapy to 12 months after finishing therapy
Secondary outcome [1] 396721 0
Severity of depression on the Depression, Anxiety and Stress Scale (DASS-21).
Timepoint [1] 396721 0
1 week pre-treatment assessment, at the beginning of each weekly CTP session, 1 week post-treatment completion, 6-months post-treatment completion
Secondary outcome [2] 396728 0
Cost of delivering therapies measured by the Commonwealth Department of Health and Aged Care schedules with clinician time recorded on a weekly basis. Clinician time will be calculated based on time spent with clients and time spent preparing for client sessions.
Timepoint [2] 396728 0
Will be recorded throughout the entire study
Secondary outcome [3] 397962 0
Additional primary outcome: Medication use from Pharmaceutical Benefits Schedule (PBS) from Services Australia. Used to inform the costs of the economic evaluation.
Timepoint [3] 397962 0
12 months prior to clients starting therapy to 12 months after finishing therapy
Secondary outcome [4] 397963 0
Additional primary outcome: Hospital admission data from DRG coding via Flinders Health Data Science and Clinical Trials (HDSCT) group. Used to inform the costs of the economic evaluation.
Timepoint [4] 397963 0
12 months prior to clients starting therapy to 12 months after finishing therapy
Secondary outcome [5] 397964 0
ICEpop CAPability measure for Adults (ICECAP-A) - measure of wellbeing used in economic evaluation.
Timepoint [5] 397964 0
1 week pre-treatment assessment, at the beginning of each weekly CTP session, 1 week post-treatment completion, 6-months post-treatment completion
Secondary outcome [6] 397965 0
Treatment Inventory of Costs in Psychiatric Patients (TIC-P) - self report measure of health care use to supplement the Medicare and hospital data being collected
Timepoint [6] 397965 0
1 week pre-treatment assessment, 1 week post-treatment completion , 6 months post-treatment completion

Eligibility
Key inclusion criteria
All client participants must be over 16 years of age and have been directly or indirectly exposed (through witnessing) to a traumatic event (e.g. interpersonal trauma such as assault, survivors of childhood abuse/family violence, motor vehicle accident, etc.) that occurred four or more weeks previously and must meet the threshold or subthreshold for PTSD based on the PTSD Checklist (PCL-5).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include individuals with moderate to severe traumatic brain injury, individuals with uncontrolled psychosis (e.g., psychosis-related symptoms that severely interfere with a client’s insight or ability to provide informed consent) or current substance dependence requiring immediate attention (e.g., detox), those with significant risk of harm (e.g. in current domestic violence situation) or those with active suicidality that requires immediate and ongoing intervention. Exclusion criteria are on the basis that the nature of the therapy (cognitive behavioural) requires a level of cognition and functioning to engage in therapy, thus higher levels of traumatic brain injury are excluded. Unmanaged substance abuse or psychosis are also exclusions for treatment, given the nature of the therapy and the need for these issues to be managed either concurrently or before treatment occurs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data related to client treatment outcomes will be analysed using IBM Statistical Package for the Social Sciences (SPSS). Simple data is analysed using standard tests (i.e., t-test, correlations, chi square, basic regression etc.). Examination of treatment effectiveness will be examined through multilevel modelling (MLM). Health economic analysis will include calculating quality adjusted life years (QALYs) from the AQoL-8D/ ICEAP-A and integrated with survival curves using the quality-adjusted survival analysis (QASA) method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
15/09/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
26/12/2022
Date of last data collection
Anticipated
31/08/2023
Actual
20/12/2023
Sample size
Target
150
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308358 0
Charities/Societies/Foundations
Name [1] 308358 0
Break Through Mental Health Research Foundation
Country [1] 308358 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country
Australia
Secondary sponsor category [1] 309178 0
None
Name [1] 309178 0
Address [1] 309178 0
Country [1] 309178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308329 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 308329 0
Ethics committee country [1] 308329 0
Australia
Date submitted for ethics approval [1] 308329 0
12/04/2021
Approval date [1] 308329 0
09/07/2021
Ethics approval number [1] 308329 0
HRE00041
Ethics committee name [2] 315688 0
Department of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [2] 315688 0
Ethics committee country [2] 315688 0
Australia
Date submitted for ethics approval [2] 315688 0
25/03/2021
Approval date [2] 315688 0
09/07/2021
Ethics approval number [2] 315688 0
2021/BN32253040

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

Contacts
Principal investigator
Name 110326 0
Prof Reg Nixon
Address 110326 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 110326 0
Australia
Phone 110326 0
+61 8 8201 2748
Fax 110326 0
+61 8 8201 3877
Email 110326 0
[email protected]
Contact person for public queries
Name 110327 0
Sheradyn Matthews
Address 110327 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 110327 0
Australia
Phone 110327 0
+61 82012264
Fax 110327 0
Email 110327 0
[email protected]
Contact person for scientific queries
Name 110328 0
Reg Nixon
Address 110328 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 110328 0
Australia
Phone 110328 0
+61 8 8201 2748
Fax 110328 0
+61 8 8201 3877
Email 110328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.