An observational study in Acute Myocardial Infarction, Tako Tsubo Cardiomyopathy and Breast Cancer, sponsored by San Filippo Neri General Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by San Filippo Neri General Hospital · Observational
Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated.
The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases .
The patients that will be enrolled are:
At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2).
In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered.
The same evaluation will be done for the healthy subjects.
After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.
At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered.
The following data will be evaluated:
Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life
At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.
Exclusion Criteria:
Short term psychotherapy + Classic cardiological therapy
Behavioral: Short Term Psychotherapy
Classic cardiological therapy only
Short term psychotherapy + Classic oncological therapy
Behavioral: Short Term Psychotherapy
Classic oncological therapy only
Short term psychotherapy + Classic cardiological therapy
Behavioral: Short Term Psychotherapy
Classic cardiological therapy only
No therapy
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
Cumulative incidence of new relevant medical events
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
Time frame: at 1 year
Cumulative incidence of new relevant medical events
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
Time frame: at 5 years
Changes in body perception and dreams
These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions.
Time frame: at 1 year
Incidence of rehospitalisations
Number of rehospitalisations during the first year of follow-up
Time frame: at 1 year
Incidence of rehospitalisations
Number of rehospitalisations during 5 years follow-up
Time frame: at 5 years
Distress grade
Self-evaluation test (score range 1-10, higher stress for higher values)
Time frame: at 1 year
Distress grade
Self-evaluation test (score range 1-10, higher stress for higher values)
Time frame: at 5 years
Depression symptoms
Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)
Time frame: at 1 year
Depression symptoms
Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)
Time frame: at 5 years
Social support
Social support questionnaire (score range 12-72, the higher the score the lower the support)
Time frame: at 1 year
Social support
Social support questionnaire (score range 12-72, the higher the score the lower the support)
Time frame: at 5 year
Quality of life
Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged)
Time frame: at 1 year
Quality of life
Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged)
Time frame: at 5 years
Anxiety grade
State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)
Time frame: At 1 year
Anxiety grade
State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)
Time frame: At 5 years
Anger level
State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)
Time frame: at 1 year
Anger level
State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)
Time frame: at 5 years
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San Filippo Neri General Hospital