A parallel randomized controlled trial compared metacognitive therapy (MCT) with prolonged exposure (PE) in 32 patients with PTSD of C3 months duration. Participants were assigned to; eight sessions of therapy (MCT or PE) or an 8-week wait period (WL). There was only one drop-out from each treatment. Both active treatments were effective, resulting in significantly lower symptoms of PTSD, anxiety and depression compared with the WL. At post-treatment MCT was superior to PE on self-report symptoms of PTSD and superior to WL on objective measures of hyper-arousal (heart-rate). Recovery rates and reliable improvement in both MCT and PE were high. MCT exerted effects more rapidly and within group effect sizes in MCT were much larger than those in PE at the end of treatment. Clinical gains remained evident at follow-up by which time the treated groups did not differ. In conclusion; both treatments were effective but MCT had a clear advantage. The clinical implications and suggestions for future research are discussed.
IntroductionMesothelioma is a heterogeneous disease that can be challenging to monitor and prognosticate. ASSESS-meso is a multicentre, prospective, longitudinal observational cohort study of patients with mesothelioma. The primary aim is to describe different clinical phenotypes and investigate predictive and prognostic factors, including biomarkers from blood and pleural fluid. The secondary aim is to provide a resource for future trials and substudies.Methods and analysisWe aim to recruit 700 patients with a histological, cytological or clinicopathological diagnosis of mesothelioma, at any anatomical site (pleural, peritoneal, pericardial, etc). Longitudinal data will be collected, including clinical information, radiological investigations, blood tests and patient-reported outcome measures for breathlessness, chest pain and sweats. Preplanned analyses will use Cox proportional hazards method to evaluate factors associated with survival, linear and logistic regression models to investigate associations with symptoms, and analysis of variance modelling to explore changes in symptoms over time.Ethics and disseminationEthical approval has been granted by the Research Ethics Committee South West—Central Bristol (17-SW-0019) and Health Research Authority (IRAS ID 220360). A study steering committee has been established and results will be published OpenAccess in peer-reviewed journals.Trial registration numberISRCTN: 61861764.
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