Abstract
: IntroductionPsychosocial 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).
Highlights
Non-Communicable Diseases (NCDs) represent 71% of all global deaths, the two most prevalent being cardiovascular diseases (CVD) and cancer [1]
Sub-analysis of STEP-IN-AMI trial data provided original insights on the relationship between emotions, dreams, and medical conditions suggesting new potential diagnostic, preventive, and therapeutic strategies. As this possibility may potentially extend to other non-communicable diseases (NCDs), two clinical diagnoses appear to be ideal initial candidates to test this hypothesis in addition to ischemic patients: Takotsubo syndrome and breast cancer
The size of the AMI group has been based on evaluation of the outcome data at one year from the results of the STEP-IN-AMI trial: a 43% incidence of the primary composite endpoint is expected in the psychotherapy group and 78% in the control group; 55 pts will be enrolled to achieve statistical power at the 95% confidence level with 80%
Summary
Non-Communicable Diseases (NCDs) represent 71% of all global deaths, the two most prevalent being cardiovascular diseases (CVD) and cancer [1]. Sub-analysis of STEP-IN-AMI trial data provided original insights on the relationship between emotions, dreams, and medical conditions suggesting new potential diagnostic, preventive, and therapeutic strategies As this possibility may potentially extend to other NCDs, two clinical diagnoses appear to be ideal initial candidates to test this hypothesis in addition to ischemic patients: Takotsubo syndrome and breast cancer. Breast cancer (BC) is an ideal case study because it has been extensively investigated from a psychosocial point of view and represents a public health priority in women worldwide Several psychological factors such as depression, hopelessness [17], anxiety, intrusive thoughts, social support [18,19], fear of recurrence [20], compassion [21], and sentimental issues [22] are known to play a complex role in the follow-up of patients with breast cancer, interfering with the quality of life, therapeutic choices, and worsening prognosis. Based on previous data from the STEP-IN-AMI trial, we have designed an observational study to obtain additional psychosomatic insights and assess the effects of ontopsychological STP in acute MI, Takotsubo, and breast cancer patients
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