Psychological Support in Adult Patients With Marfan Syndrome
Rare Diseases · Marfan Syndrome · Psychology, Social
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 125 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
MFS_PT+
MFS patients who followed psychological support/psychotherapy
Other: Questionnaire
MFS_PT-
MFS patients who never followed psychological support/psychotherapy
Other: Questionnaire
Questionnaire OTHER
Rosenberg Self- Esteem scale
Questionnaire OTHER
Short Form 36 scale
Questionnaire OTHER
Coping orientation to the problems experienced - New Version in Italian
Questionnaire OTHER
Outcome Questionnaire - version 42.5
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
\- COPE NVI: scoring between 60 and 240; higher score means better outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
\- Short Form-36: scoring between 0 and 100; higher score means better outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
\- Rosenberg Self- Esteem scale: scoring between 0 and 30; higher score means better outcome
Questionnaire performance
Time frame: 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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
IRCCS Policlinico San DonatoSan Donato Milanese, Lombardy, ItalyRecruiting
Study team and timeline
- Lead sponsor
- IRCCS Policlinico S. Donato
- Study start
- Jan 9, 2023 Actual
- Primary completion
- Feb 9, 2027 Estimated
- Study completion
- Oct 9, 2027 Estimated
- First posted
- Feb 3, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026