Psychological Support in Adult Patients With Marfan Syndrome

Recruiting

• Conditions: Rare Diseases; Marfan Syndrome; Psychology, Social
• Interventions: Other: Questionnaire

• Registration Number: NCT05712577
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

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 Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

Exclusion Criteria

• Subjects with cognitive deficits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MFS_PT-	Questionnaire	MFS patients who never followed psychological support/psychotherapy
MFS_PT+	Questionnaire	MFS patients who followed psychological support/psychotherapy

Primary Outcome Measures

Name	Time	Method
Questionnaire performance	8 Months	Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.; Questionnaire scoring: - Outcome questionnaire 42.5: socring between 0 and 180; clinical cut-off value is 64, higher score means worse outcome

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Lombardia, Italy