Clinical Efficacy and Cost-Effectiveness of Imagery Rescripting Only Compared to Imagery Rescripting and Schema Therapy in Adult Patients With PTSD and Comorbid Cluster C Personality Disorder: Study Design of a Randomized Controlled Trial

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.

Self‐rated personality disorder symptoms do not predict treatment outcome for posttraumatic stress disorder in routine clinical care

“…Adding concurrent PD treatment to trauma‐focused treatment may enhance treatment effects for both disorders. Two randomized controlled trials testing this hypothesis are currently being conducted (Snoek et al, 2020; Van den End et al, 2021). Finally, the present study tested the predictive value of a predictor on treatment change at a group level.…”

“…If PD is indeed a predictor of attenuated PTSD treatment outcome, this has clinical implications. For example, those with comorbid PD may benefit from integrated PTSD and PD focused treatment (a hypothesis currently under investigation by Snoek et al, 2020; van den End et al, 2021). Early detection and stratification to the appropriate treatment modality may increase the chance of therapy to be effective.…”

Brain activation during an emotional task in participants with PTSD and borderline and/or cluster C personality disorders

“…Participants in this study were part of two larger randomized controlled trials in the PROSPER-study, see also Snoek et al, 2020 , van den End et al, 2021 . Inclusion criteria were at least three traits of avoidant or obsessive–compulsive personality disorder, and/or four traits of dependent or BPD (i.e.…”

Trauma-focused and personality disorder treatment for posttraumatic stress disorder and comorbid cluster C personality disorder: a randomized clinical trial

“…A single-blinded RCT with two arms was conducted at two sites of the Sinai Center, a mental health institution specialized in PTSD treatment in The Netherlands. The present study was registered under NCT03833531 on ClinicalTrials.gov and approved by the regional Medical Ethics Committee (reference number 2017.335) and the study design has been published elsewhere (van den End et al, 2021 ). The study was conducted in accordance with the Dutch Medical Research Involving Human Subjects Act.…”

“…It is aimed at changing emotional and cognitive aspects of aversive memories by changing the course of events within the traumatic memory by using imagination. A detailed description of the ImRs procedure has been published elsewhere (van den End et al, 2021 ). The ImRs protocol was based on the protocol used in a previous study on ImRs and consisted of a minimum of twelve and a maximum of 18 75 min individual sessions (Raabe et al, 2015 ).…”