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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD); Mental Health - Other mental health disorders

• Registration Number: ACTRN12617000064303
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Post treatment and at six month follow up];Proportion of participants with a reduction in levels of Depression, Stress and Anxiety as measured on the DASS-21.[Post treatment and at six month follow up]

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a reduction in alcohol use if applicable, as measured by the Alcohol Use Disorders Identification Test (AUDIT).<br><br><br>[Post treatment and at six month follow up];Proportion of participants with a reduction in severity of insomnia if applicable, as measured by the Insomnia Severity Index (ISI).[Post treatment and at six month follow up];Proportion of participants with improved emotional regulation, if applicable, as assessed by the Difficulties in Emotional Regulation Scale (DERS).[Post treatment and at six month follow up];Proportion of participants with a reduction in cannabis use if applicable, as measured by the Cannabis Use Disorders Identification Test (CUDIT).[Post treatment and at six month follow up];Proportion of participants with a reduction in drug use, if applicable, as measured by the Drug Use Disorders Identification Test (DUDIT).[Post treatment and at six month follow up]