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The Effectiveness of Combining Cognitive Processing Therapy with a Case Formulation Approach in the Treatment of Posttraumatic Stress Disorder - A Randomised Controlled Trial

The Effectiveness of Combining Cognitive Processing Therapy with a Case Formulation Approach in the Treatment of Posttraumatic Stress Disorder - A Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000064303
Enrollment
93
Registered
2017-01-12
Start date
2017-02-16
Completion date
2018-12-31
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Trauma focused cognitive behavioural therapy has long been the standard approach for the treatment of posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is a manualised treatment protocol based on a cognitive behavioural therapy approach, typically delivered over 12 sessions. Whilst CBT approaches have good efficacy in the treatment of PTSD, the non-response to treatment and dropout rates remain substantial. This study is for the purposes of a PhD, and examines the combination of CPT with a case formulation approach (CPT+CF), which individualises therapy based on the needs of the client and allows for deviation from the standard treatment protocol. It is hypothesised that this approach will be superior to the standard CPT protocol, resulting in greater reductions of PTSD symptoms, less dropout, and better good end-state functioning. It is anticipated that CPT+CF will be most beneficial in the face of complicated client presentations, that is, treatment outcomes will be moderated by client complexity.

Interventions

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’,

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026