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Introduction Psychosocial factors play an important role in non-communicable diseases (NCDs). This observational study is primarily aimed at assessing the relationship of psychological characteristics of patients with the outcomes of different NCDs, and to assess short-term psychotherapy (STP) efficacy in the real world. Methods: One hundred and forty patients with recent acute myocardial infarction, Takotsubo syndrome, or non-metastatic breast cancer and a control group of 140 age and sex-matched healthy subjects, will be enrolled. All subjects will be administered psychometric tests, quality of life tests, a specific body perception questionnaire, a dream questionnaire, and a projective test, the Six Drawing test at baseline and follow-up. All subjects with medical conditions will be asked to freely choose between an ontopsychological STP along with standard medical therapy and, whenever indicated, rehabilitation therapy or medical therapy plus rehabilitation alone. The study endpoints will be to evaluate: the relationship of the psychological characteristics of enrolled subjects with the outcomes of different NCDs, predictors of the choice of psychotherapy, and the efficacy of ontopsychological intervention on psychological and medical outcomes. Conclusion: This study will generate data on distinctive psychological characteristics of patients suffering from different CDs and their relationship with medical outcomes, as well as explore the efficacy of ontopsychological STP in these patients in the real world. (Number of registration: NCT03437642).

Sustained disability improvement was observed in about 30% of patients with multiple sclerosis (MS) treated with natalizumab (Tysabri, Biogen Idec, Cambridge, Massachusetts, USA), thus suggesting the occurrence of reversal of neurological dysfunction.1 In addition to its striking effect in suppressing contrast-enhancing lesions and new or enlarged T2-hyperintense lesions on MRI by 92% and 83%, respectively,2 natalizumab was also reported to induce a decrease in lesion volumes on T2-weighted and T1-weighted images by 9.4% and 23.5%, respectively, over a 24-month follow-up.3 Nevertheless, the relationship between sustained disability improvement and reduction in MRI lesion burden during treatment with natalizumab has not been elucidated yet. We collected clinical and MRI data from 88 patients (58 women, 30 men) treated with natalizumab at the MS Center of S Andrea Hospital in Rome (Italy). Brain MRI scans were acquired using a 1.5T magnet (GE Signa Excite) within 4 weeks before natalizumab start (baseline) and after 6 and 24 months (±4 weeks) of treatment. Hyperintense lesion volume on post-gadolinium T1-weighted images (GD-LV), T2-weighted images (T2-LV), and hypointense lesion volumes on T1-weighted images (T1-LV), were measured using a local thresholding segmentation technique (Jim 5.0, Xinapse Systems, Leicester, UK). Regions of interest were identified by the agreement of two trained operators (FDA and RDA) unaware of clinical data. Patients were divided into three groups according to changes in their disability status at the end of the 24-month follow-up versus baseline, as follows: (1) 6-month sustained reduction of ≥1-point in Expanded Disability Status Scale (EDSS) score; (2) stable or …