Clinical Trial Details

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

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Trial Information

Broad Health Condition Mental Health

Specific Health ConditionOther mental health disorders

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
SA

Anticipated date of first participant enrolment16/02/2017

Anticipated date of last participant enrolment16/02/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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.
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 age18 Years

GenderBoth 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). 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Flinders University
Primary Sponsor Address: School of Psychology Flinders University GPO Box 2100 Adelaide 5001 South Australia
Primary Sponsor Country: Australia

Trial websitehttp://www.flinders.edu.au/sabs/psychology/services/posttraumatic-stress-research-unit/

Trial IDACTRN12617000064303

Contact person for information and recruitmentProf
Reg Nixon
School of Psychology Flinders University GPO Box 2100 Adelaide 5001 South Australia
+61882012748
+61882013877
Further information iconreg.nixon@flinders.edu.au
Australia