Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000064303
Ethics application status
Approved
Date submitted
3/01/2017
Date registered
12/01/2017
Date last updated
21/08/2020
Date data sharing statement initially provided
19/02/2019
Date results provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Combining Cognitive Processing Therapy with a Case Formulation Approach in the Treatment of Posttraumatic Stress Disorder - A Randomised Controlled Trial
Scientific title
The Effectiveness of Combining Cognitive Processing Therapy with a Case Formulation Approach in the Treatment of Posttraumatic Stress Disorder - A Randomised Controlled Trial
Secondary ID [1] 290825 0
Nil Known
Secondary ID [2] 290890 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 301493 0
Condition category
Condition code
Mental Health 301204 301204 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Group One: CPT only
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. For the present study, up to 15 sessions of CPT will be offered in the CPT alone condition. Sessions will generally be conducted 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.

Treatment Group Two - CPT + Case Formulation
CPT+CF will include a case formulation approach based on the processes suggested by (Kuyken et al., 2009) which integrates clients’ experiences with relevant CBT research. As such the formulation will be in diagrammatic form, focusing on the client’s thoughts, feelings, physiological sensations and behaviour as it relates to the trauma event. In addition imagery will be utilised given symptoms often include strong visual images and flashbacks to the trauma. In order to individualise the formulation and ensure that other presenting issues are identified, past experiences, both distal and proximal events that might be relevant will be included (e.g., the experience of severe childhood bullying might have also influenced the unhelpful or core beliefs of a client who has also experienced domestic violence). Client’s capabilities and strengths are also examined. This explicit CF will be introduced in Session 1 and will be revisited as needed, especially in the context of treatment gains not being observed during therapy (as tracked by the weekly administration of the PCL and DASS-21). Thus this formulation can guide the therapist to barriers in treatment and help with decisions such as whether to target a particular comorbidity that might be interfering with treatment. The explicit goal of the CPT+CFT approach is to ensure a trauma-focus to therapy, thus where deviation from the CPT protocol occurs, the ultimate goal of treatment is to return to addressing PTSD symptoms. Where other interventions are introduced to assist with this goal (e.g., targeting of comorbid panic attacks that are interfering with engaging in trauma-specific work), these additional interventions will be CBT and evidence-based.

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 15 sessions of CPT will be offered in the CPT+CF condition. Sessions will generally be conducted 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, treatment allocation or stage or treatment reached will be used at post and six-month follow up assessments. Assessors will conduct post treatment interviews and questionnaires with participants, and again at the six month mark.

The majority of treatment for both groups will be conducted by the researcher, a registered psychologist trained in the CPT protocol and case formulation approach. When required, other therapists will be used for either treatment group. All other therapists will be currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Trauma Unit. Therapists will receive weekly supervision from Professor Nixon.

The researcher will be located at Yarrow Place to provide on site therapy to Yarrow Place clients one day per week and will also provide therapy on site at the Trauma Unit at Flinders University Campus. Each session is anticipated to last 1 to 1.5 hours.
Intervention code [1] 296746 0
Treatment: Other
Intervention code [2] 296834 0
Behaviour
Comparator / control treatment
Participants will be randomly assigned to one of two treatment groups; the first “treatment as usual” group will undergo the standard manualised CPT approach (CPT). The second group will use a combination of CPT and case formulation (CPT+CF), allowing deviation from the protocol if required to address issues obstructing progress in therapy.

Control group
Active

Outcomes
Primary outcome [1] 300621 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] 300621 0
Post treatment and at six month follow up
Primary outcome [2] 300677 0
Proportion of participants with a reduction in levels of Depression, Stress and Anxiety as measured on the DASS-21.
Timepoint [2] 300677 0
Post treatment and at six month follow up
Secondary outcome [1] 330426 0
Proportion of participants with a reduction in alcohol use if applicable, as measured by the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [1] 330426 0
Post treatment and at six month follow up
Secondary outcome [2] 330596 0
Proportion of participants with a reduction in severity of insomnia if applicable, as measured by the Insomnia Severity Index (ISI).
Timepoint [2] 330596 0
Post treatment and at six month follow up
Secondary outcome [3] 330597 0
Proportion of participants with improved emotional regulation, if applicable, as assessed by the Difficulties in Emotional Regulation Scale (DERS).
Timepoint [3] 330597 0
Post treatment and at six month follow up
Secondary outcome [4] 330697 0
Proportion of participants with a reduction in cannabis use if applicable, as measured by the Cannabis Use Disorders Identification Test (CUDIT).
Timepoint [4] 330697 0
Post treatment and at six month follow up
Secondary outcome [5] 330698 0
Proportion of participants with a reduction in drug use, if applicable, as measured by the Drug Use Disorders Identification Test (DUDIT).
Timepoint [5] 330698 0
Post treatment and at six month follow up

Eligibility
Key inclusion criteria
All participants must be over 18 years of age and 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 15 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher will be in charge of the randomisation sheet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation method will be utilised in order to balance covariariates. A covariate adaptive randomisation table will be utilised created on an Excel spreadsheet.

Stratified allocation will be based on the following:
- PTSD symptoms as measured on the Clinician Administered PTSD Scale (CAPS-5) with a score of 40 and above to ensure comparable severity across groups.
- Gender
- Interpersonal trauma type
- Co-morbid symptoms (i.e. mood disorder, anxiety disorder, substance use/dependence, psychosis or eating disorder)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A mixed 2 (Group: CF+CPT, CPT) x 3 (Time: pretreatment, posttreatment, 6-month follow-up) design will be adopted
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 six-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
Completed
Date of first participant enrolment
Anticipated
16/02/2017
Actual
16/02/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
30/06/2019
Actual
10/01/2020
Sample size
Target
80
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 295249 0
University
Name [1] 295249 0
Flinders University
Country [1] 295249 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country
Australia
Secondary sponsor category [1] 294078 0
Other
Name [1] 294078 0
Yarrow Place Rape and Sexual Assault Service
Address [1] 294078 0
2/55 King William Rd,
North Adelaide 5006
South Australia
Country [1] 294078 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296588 0
Women's and Children's Health Network Human Research Ethics Committee (EC00197)
Ethics committee address [1] 296588 0
Ethics committee country [1] 296588 0
Australia
Date submitted for ethics approval [1] 296588 0
08/07/2016
Approval date [1] 296588 0
15/09/2016
Ethics approval number [1] 296588 0
HREC/16/WCHN/113

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1346 1346 0 0
/AnzctrAttachments/372084-CPT CF Information Sheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 71394 0
Prof Reg Nixon
Address 71394 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 71394 0
Australia
Phone 71394 0
+61882012748
Fax 71394 0
+61882013877
Email 71394 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 71395 0
Reg Nixon
Address 71395 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 71395 0
Australia
Phone 71395 0
+61882012748
Fax 71395 0
+61882013877
Email 71395 0
reg.nixon@flinders.edu.au
Contact person for scientific queries
Name 71396 0
Reg Nixon
Address 71396 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 71396 0
Australia
Phone 71396 0
+61882012748
Fax 71396 0
+61882013877
Email 71396 0
reg.nixon@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.