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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.

SUBMITTER: van den End A

PROVIDER: S-EPMC8044980 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNeural alterations related to treatment outcome in patients with both post-traumatic stress disorder (PTSD) and comorbid personality disorder are unknown. Here we describe the protocol for a neuroimaging study of treatment of patients with PTSD and comorbid borderline (BPD) or cluster C (CPD) personality disorder traits. Our specific aims are to 1) investigate treatment-induced neural alterations, 2) predict treatment outcome using structural and functional magnetic resonance imaging (MRI) and 3) study neural alterations associated with BPD and CPD in PTSD patients. We hypothesize that 1) all treatment conditions are associated with normalization of limbic and prefrontal brain activity and hyperconnectivity in resting-state brain networks, with additional normalization of task-related activation in emotion regulation brain areas in the patients who receive trauma-focused therapy and personality disorder treatment; 2) Baseline task-related activation, together with structural brain measures and clinical variables predict treatment outcome; 3) dysfunction in task-related activation and resting-state connectivity of emotion regulation areas is comparable in PTSD patients with BPD or CPD, with a hypoconnected central executive network in patients with PTSD+BPD.MethodsWe aim to include pre- and post-treatment 3 T-MRI scans in 40 patients with PTSD and (sub) clinical comorbid BPD or CPD. With an expected attrition rate of 50%, at least 80 patients will be scanned before treatment. MRI scans for 30 matched healthy controls will additionally be acquired. Patients with PTSD and BPD were randomized to either EMDR-only or EMDR combined with Dialectical Behaviour Therapy. Patients with PTSD and CPD were randomized to Imaginary Rescripting (ImRs) or to ImRs combined with Schema Focused Therapy. The scan protocol consists of a T1-weighted structural scan, resting state fMRI, task-based fMRI during an emotional face task and multi-shell diffusion weighted images. For data analysis, multivariate mixed-models, regression analyses and machine learning models will be used.DiscussionThis study is one of the first to use neuroimaging measures to predict and better understand treatment response in patients with PTSD and comorbid personality disorders. A heterogeneous, naturalistic sample will be included, ensuring generalizability to a broad group of treatment seeking PTSD patients.Trial registrationClinical Trials, NCT03833453 & NCT03833531 . Retrospectively registered, February 2019.

Project description:ImportanceTraumatic digit amputation is the most common type of amputation injury, but the cost-effectiveness of its treatments is unknown.ObjectiveTo assess the cost-effectiveness of finger replantation compared with revision amputation.Design, setting, and participantsThis economic evaluation was conducted using data from the Finger Replantation and Amputation Challenges in Assessing Impairment, Satisfaction, and Effectiveness (FRANCHISE), a retrospective, multicenter cohort study at 19 centers in the United States and Asia that enrolled participants from August 1, 2016, to April 12, 2018. Model variables were based on the FRANCHISE database, Centers for Medicare & Medicaid Services, and published literature. A total of 257 participants with unilateral traumatic finger amputations treated with revision amputation or replantation distal to the metacarpophalangeal joint and at least 1 year of follow-up after treatment were included in the analysis.ExposuresRevision amputation or replantation of traumatic finger amputations.Main outcomes and measuresMain outcome measures were quality-adjusted life-years (QALYs), total costs (in US dollars), and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per QALY was used to assess cost-effectiveness.ResultsOf the 257 study participants (mean [SD] age, 46.7 [15.9] years; 221 [86.0%] male), 178 underwent finger replantation and 79 underwent revision amputation. In a base case of a 46.7-year-old patient, replantation was associated with QALY gains of 0.30 (95% credible interval [CrI], -0.72 to 1.38) for single-finger (not thumb), 0.39 (95% CrI, -1.00 to 1.90) for thumb, 1.69 (95% CrI, -0.13 to 3.76) for multifinger excluding thumb, and 1.27 (95% CrI, -2.21 to 5.04) for multifinger including thumb injury patterns. Corresponding ICERs for replantation compared with revision amputation were $99 157 per QALY for single-finger (not thumb), $66 278 per QALY for thumb, $18 388 per QALY for multifinger excluding thumb, and $21 528 per QALY for multifinger including thumb injury patterns. Sensitivity analysis revealed that age at time of injury, life expectancy, postinjury utility, wages, and time off work for recovery had the strongest associations with cost-effectiveness. Probabilistic sensitivity analysis revealed the following chances of replantation being cost-effective: 47% in single-finger (not thumb), 52% in thumb, 78% in multifinger excluding thumb, and 64% in multifinger including thumb injury patterns.Conclusions and relevanceWith proper patient selection, replantation of all finger amputation patterns, whether single-finger or multifinger injuries, may be cost-effective compared with revision amputation. Multifinger replantations had a higher probability of being cost-effective than single-finger replantations. Cost-effectiveness may depend on injury pattern and patient factors and thus appears to be important for consideration when patients and surgeons are deciding whether to replant or amputate.

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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.

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