MARFANPSY: Psychological Support in Adult Patients With Marfan Syndrome

Sponsor

IRCCS Policlinico S. Donato (Other)

Overall Status

Recruiting

CT.gov ID

NCT05712577

Collaborator

(none)

125

Enrollment

Location

11.7

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to identify key factors leading to psychotherapy or psychological support in adult subjects with Marfan syndrome (MSF). the main questions it aims to answer are:

Understand and define which internal variables of the individual drive this request for psychological support;
To learn about verify the impact that the clinical manifestations of MSF have on psychosocial aspects, self-esteem, subjective perception of the disease and coping mechanisms.

Condition or Disease	Intervention/Treatment	Phase
Rare Diseases Marfan Syndrome Psychology, Social	Other: Questionnaire

Detailed Description

Patients following psychological interview during follow-up visits will be enrolled in the study.

The following self-report questionnaires will be used in understanding the impact the syndrome has on mental health and quality of life:

Rosenberg Self- Esteem: 10 item Likert scale for assessing self-esteem;
SF 36: 36 item scale assessing eight domains: physical functioning physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health;
Cope NVI: to test measures coping behaviors as potential responses to stressors like social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation;
OQ45.2: measure of general psychological distress.

Study Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels

Actual Study Start Date :

Jan 9, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
MFS_PT+ MFS patients who followed psychological support/psychotherapy	Other: Questionnaire Rosenberg Self- Esteem; SF36; Cope NVI; OQ45.2
MFS_PT- MFS patients who never followed psychological support/psychotherapy	Other: Questionnaire Rosenberg Self- Esteem; SF36; Cope NVI; OQ45.2

Arm

Intervention/Treatment

MFS_PT+

MFS patients who followed psychological support/psychotherapy

Other: Questionnaire

Rosenberg Self- Esteem; SF36; Cope NVI; OQ45.2

MFS_PT-

MFS patients who never followed psychological support/psychotherapy

Other: Questionnaire

Rosenberg Self- Esteem; SF36; Cope NVI; OQ45.2

Outcome Measures

Primary Outcome Measures

Questionnaire performance [8 Months]
analysis (between subjects) ANOVA associated with a Principal Component Analysis (PCA) with VARIMAX rotation to cluster the indexes of questionnaires with similar trends.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects affected by Marfan syndrome;
Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;
Signed informed consent.