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Trial registered on ANZCTR


Registration number
ACTRN12619000503123
Ethics application status
Approved
Date submitted
26/03/2019
Date registered
28/03/2019
Date last updated
28/04/2020
Date data sharing statement initially provided
28/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Processing Therapy for Posttraumatic Stress Disorder in First Responders and Veterans: flexing the approach
Scientific title
Cognitive Processing Therapy for Posttraumatic Stress Disorder in First Responders and Veterans: flexing the approach
Secondary ID [1] 297782 0
Nil Known
Universal Trial Number (UTN)
U1111-1230-5195
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic Stress Disorder 312133 0
Condition category
Condition code
Mental Health 310686 310686 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Processing Therapy is a recognised CBT based approach for the treatment of PTSD. It comprises 12 sessions of material that follows a manualised format developed by Resick, Monsoon and Chard (2007). Initial sessions provide a rationale for the approach and an overview of treatment. Psychoeducation about PTSD and the basics of cognitive theory are discussed, with the client completing an Impact Statement that assists in the identification of ‘stuck points’, or problematic thinking about the traumatic event. In subsequent sessions the connection between events, thoughts and feelings are introduced and applied to the Impact Statement. Now optional in CPT, clients can also write a detailed description of the event through a Trauma Account. Clients continue to work through their stuck points as they relate to the traumatic event, with the therapist using a variety of techniques including Socratic questioning and challenging questions about stuck points and problematic thinking. Later modules on safety, trust, power and control, esteem and intimacy all address beliefs about each theme.

The researchers have developed a flexible adaptation of CPT to address issues which might affect client retention and increase effectiveness of the therapy by offering a case formulation approach which allows for planned deviations from CPT when therapy progress stalls or barriers appear. For example, sessions to target comorbid depression, affect dysregulation or alcohol abuse. All deviations from the CPT protocol will be documented using a form created for the purpose. This will include the nature of the deviation, the time spent and whether the deviations are considered minor or major. For the present study, up to 25 sessions of CPT will be offered. Sessions will generally be conducted for approximately 60 minutes on a weekly basis face-to-face and on an individual basis. Sessions may be more frequent (twice weekly) depending on client preference and therapist discretion.

To ensure diagnostic reliability, all pretreatment diagnostic interviews and therapy sessions will be video/audiotaped and will be coded by a research assistant to ensure that the therapist is adhering to the components of each treatment session. By adopting this design the proposed research conforms to the gold standard for conducting treatment outcome research with traumatised samples (Foa & Meadows, 1997), and ensures the methodological rigour of the proposed project.

Assessors who have no knowledge of the participants or stage or treatment reached will be used at post and three-month follow up assessments. Assessors will conduct post treatment interviews and questionnaires with participants, and again at the three month mark.

Therapists involved are either registered psychologists or currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Trauma Unit. All therapists will have training in the CPT protocol and case formulation approach. Therapists will receive weekly supervision from Professor Nixon.
Intervention code [1] 314018 0
Treatment: Other
Intervention code [2] 314019 0
Behaviour
Comparator / control treatment
Study is an open trial - there is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319532 0
Proportion of participants with a reduction in PTSD symptom severity as measured on the Post traumatic stress disorder checklist (PCL-5) and the Clinician Administered PTSD Scale (CAPS).
Timepoint [1] 319532 0
Post treatment and at three-month follow up
Primary outcome [2] 319533 0
Proportion of participants with a reduction in levels of Depression, Stress and Anxiety as measured on the DASS-21.
Timepoint [2] 319533 0
Post treatment and at three-month follow up
Secondary outcome [1] 368589 0
Proportion of participants with a reduction in alcohol use if applicable, as measured by the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [1] 368589 0
Post treatment and at three-month follow up
Secondary outcome [2] 368590 0
Proportion of participants with a reduction in severity of insomnia if applicable, as measured by the Insomnia Severity Index (ISI).
Timepoint [2] 368590 0
Post treatment and three-month follow up
Secondary outcome [3] 368591 0
Proportion of participants with improved anger, if applicable, as assessed by the Difficulties in Anger Regulation Scale (DARS).
Timepoint [3] 368591 0
Post treatment and three-month follow up
Secondary outcome [4] 368592 0
Proportion of participants with a reduction in cannabis use if applicable, as measured by the Cannabis Use Disorders Identification Test (CUDIT).
Timepoint [4] 368592 0
Post treatment and at three-month follow up

Eligibility
Key inclusion criteria
All participants must be first responders or emergency services personnel (i.e. police, fire service, ambulance officers, CFA) or veterans or active duty military personnel over 18 years of age. Participants must have been directly or indirectly exposed (through witnessing) to a traumatic event (e.g. assault, motor vehicle accident, homicide etc.) four or more weeks prior to inclusion in the study and have met the threshold for PTSD.

Participants must be able to commit to up to 25 therapy sessions (usually conducted weekly).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the study include failing to meet the symptom criteria as assessed on the Clinician Administered PTSD Scale (Blake et al 1990); and scoring a sub-threshold level of PTSD as indicated by a cut off of 33 or below on the PCL-5 (as recommended by the National Centre for PTSD). Other exclusion criteria also include individuals with moderate to severe traumatic brain injury, individuals with uncontrolled psychosis or current substance dependence, those with significant risk of harm (e.g. in current domestic violence situation) or those with active suicidality.

Exclusion criteria are on the basis that the nature of the therapy (cognitive behavioural) requires a level of cognition and functioning which enables participation 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. Rationale for exclusion of participants who are at risk of harm includes that if someone is in imminent danger, or is a danger to themselves or others, then treatment of PTSD is not the immediate treatment goal (Resick, Monson, & Chard, 2014).

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
A linear mixed effects modelling analysis will be utilised, as this allows analysis of repeated measures and estimates missing data. Response to treatment and good end-state functioning will be assessed by a reduction in symptom severity of PTSD and depression, stress and anxiety using reliable change indices (RCI) and relevant cut-offs for the measures of interest (Forbes et al., 2012; Jacobson & Truax, 1991; Monson et al., 2006; Walter, Dickstein, Barnes, & Chard, 2014).

Clients who do not complete the therapy (non-completers) will be asked to participate in post-treatment and three-month follow up assessments. This data will be used for intent-to-treat analyses, and is preferable to the more conservative method of last observation carried forward (LOCF).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
10/07/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
35
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 302305 0
Charities/Societies/Foundations
Name [1] 302305 0
The Road Home
Country [1] 302305 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] 302182 0
None
Name [1] 302182 0
Address [1] 302182 0
Country [1] 302182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302980 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 302980 0
Ethics committee country [1] 302980 0
Australia
Date submitted for ethics approval [1] 302980 0
Approval date [1] 302980 0
07/07/2017
Ethics approval number [1] 302980 0
HREC/14/SAC/270

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

Contacts
Principal investigator
Name 92054 0
Prof Reg Nixon
Address 92054 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 92054 0
Australia
Phone 92054 0
+618 8201 2748
Fax 92054 0
+61882012748
Email 92054 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 92055 0
Reg Nixon
Address 92055 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 92055 0
Australia
Phone 92055 0
+618 8201 2748
Fax 92055 0
+61882012748
Email 92055 0
reg.nixon@flinders.edu.au
Contact person for scientific queries
Name 92056 0
Reg Nixon
Address 92056 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 92056 0
Australia
Phone 92056 0
+618 8201 2748
Fax 92056 0
+61882012748
Email 92056 0
reg.nixon@flinders.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1733Other    Participant Information Sheet 377249-(Uploaded-26-03-2019-12-20-05)-Study-related document.pdf
1734Informed consent form    377249-(Uploaded-26-03-2019-12-20-27)-Study-related document.pdf



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.