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OpenTrials
Completed

NCT Number: NCT05752253

Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

The goal of this interventional study is to determine the incidence of depression, anxiety, sleep disturbances and resilience in a sample of subjects affected by Hereditary Hemorrhagic Telangiectasia. The study is declined through the evaluation of some outcome parameters at the time of enrollment (T0), during the counseling intervention (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention.

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Key information

Conditions

Hereditary Hemorrhagic Telangiectasia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Recruited subjects have a diagnosis of Hereditary Hemorrhagic Telangiectasia and are 18 years of age or older.

Exclusion criteria

Previous or current intellectual disability and a diagnosis of psychiatric disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.

Treatment and study plan

Counseling

Other

Counseling is a process which, through positive orientation and the enhancement of personal resources, is aimed at promoting the improvement of the quality of life in the other.

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 months

    Administration of psychometric scales

  2. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 12 months

    Administration of psychometric scales

  3. Pittsburgh Sleep Quality Index (PSQI);

    Time frame: 12 months

    Administration of psychometric scales

Secondary outcomes

  1. Impact of counseling on clients affected by rare diseases

    Time frame: 12 months

    Administration of psychometric scales

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2023
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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