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Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

NCT03437642 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2019-09-18

No results posted yet for this study

Summary

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:

* 50 patients ≤ 75 year old with acute myocardial infarction;
* 30 patients ≤ 75 year old with Tako-Tsubo syndrome;
* 50 women ≤ 75 year old, recently operated on breast cancer:
* 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.

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.

Conditions

  • Acute Myocardial Infarction
  • Tako Tsubo Cardiomyopathy
  • Breast Cancer

Interventions

BEHAVIORAL

Short Term Psychotherapy

Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs

Sponsors & Collaborators

  • San Filippo Neri General Hospital

    lead OTHER

Principal Investigators

  • Adriana Roncella, MD · San Filippo Neri General Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03437642 on ClinicalTrials.gov