Abstract
Background: Posttraumatic stress disorder (PTSD) is a serious and relatively common mental disorder causing a high burden of suffering. Whereas evidence-based treatments are available, dropout and non-response rates remain high. PTSD and Cluster C personality disorders (avoidant, dependent or obsessive-compulsive personality disorder; CPD) are highly comorbid and there is evidence for suboptimal treatment effects in this subgroup of patients. An integrated PTSD and CPD treatment may be needed to increase treatment efficacy. However, no studies directly comparing the efficacy of regular PTSD treatment and treatment tailored to PTSD and comorbid CPD are available. Whether integrated treatment is more effective than treatment focused on PTSD alone is important, since (1) no evidence-based guideline for PTSD and comorbid CPD treatment exists, and (2) treatment approaches to CPD are costly and time consuming. Present study design describes a randomized controlled trial (RCT) directly comparing trauma focused treatment with integrated trauma focused and personality focused treatment.Methods: An RCT with two parallel groups design will be used to compare the clinical efficacy and cost-effectiveness of “standalone” imagery rescripting (n = 63) with integrated imagery rescripting and schema therapy (n = 63). This trial is part of a larger research project on PTSD and personality disorders. Predictors, mediators and outcome variables are measured at regular intervals over the course of 18 months. The main outcome is PTSD severity at 12 months. Additionally, machine-learning techniques will be used to predict treatment outcome using biopsychosocial variables.Discussion: This study protocol outlines the first RCT aimed at directly comparing the clinical efficacy and cost-effectiveness of imagery rescripting and integrated imagery rescripting and schema therapy for treatment seeking adult patients with PTSD and comorbid cluster C personality pathology. Additionally, biopsychosocial variables will be used to predict treatment outcome. As such, the trial adds to the development of an empirically informed and individualized treatment indication process.Clinical Trial registration: ClinicalTrials.gov, NCT03833531.
Highlights
Posttraumatic stress disorder (PTSD) is a serious mental disorder characterized by intrusive symptoms, persistent avoidance, changes in cognition, affect, arousal and reactivity [1]
The present study addresses these knowledge gaps by comparing treatment efficacy and cost-effectiveness of trauma focused treatment (ImRs) with integrated imagery rescripting (ImRs) and Personality disorder (PD) focused treatment (ST)
It is hypothesized that ImRs and schema therapy (ST) is more efficacious than ImRs only, both from a clinical as well as from an economic cost-effectiveness point of view
Summary
Posttraumatic stress disorder (PTSD) is a serious mental disorder characterized by intrusive symptoms, persistent avoidance, changes in cognition, affect, arousal and reactivity [1]. These symptoms occur in response to exposure to (threat of) death, serious injury or sexual violation. A recent study comparing ImRs and eye movement desensitization and reprocessing, a well-established evidencebased treatment for PTSD, showed that the two approaches were safe and effective in a population of patients with PTSD from childhood trauma [17]. PTSD and Cluster C personality disorders (avoidant, dependent or obsessive-compulsive personality disorder; CPD) are highly comorbid and there is evidence for suboptimal treatment effects in this subgroup of patients. Present study design describes a randomized controlled trial (RCT) directly comparing trauma focused treatment with integrated trauma focused and personality focused treatment
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