Psychological Support in Adult Patients With Marfan Syndrome (MARFANPSY)

January 11, 2024 updated by: Alessandro Pini, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardia
      • San Donato Milanese, Lombardia, Italy, 20097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MFS_PT+
MFS patients who followed psychological support/psychotherapy
Other: Questionnaire
Rosenberg Self- Esteem scale
Other: Questionnaire
Short Form 36 scale
Other: Questionnaire
Coping orientation to the problems experienced - New Version in Italian
Other: Questionnaire
Outcome Questionnaire - version 42.5
MFS_PT-
MFS patients who never followed psychological support/psychotherapy
Other: Questionnaire
Rosenberg Self- Esteem scale
Other: Questionnaire
Short Form 36 scale
Other: Questionnaire
Coping orientation to the problems experienced - New Version in Italian
Other: Questionnaire
Outcome Questionnaire - version 42.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 Months
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
8 Months
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
8 Months
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
8 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Investigators

  • Principal Investigator: Alessandro Pini, MD, Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

October 9, 2024

Study Completion (Estimated)

October 9, 2024

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarfanPsy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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