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Completed

NCT Number: NCT05752344

Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era

The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who have accepted to be subjected to remote monitoring and diagnostic investigation. The aim of the study is the evaluation of some outcome parameters at the time of enrollment (T0), and at the end (T1) of subjects affected by Intersitial Cystitis who have carried out a monitoring of the dimensions of the psychic sphere concerning: depression, trait anxiety, state anxiety , well-being, self-efficacy, resilience.The objective is also to evaluate the presence of evolutionary and maturational trends in the mental set-up of the people who participated in the individual counseling intervention.

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Key information

Conditions

Cystitis, Interstitial Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Rome, ROMA, 00168, Italy

Who can participate

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

Inclusion criteria

  • Recruited subjects have a diagnosis of Interstitial Cystitis and are 18 years of age or older.

Exclusion criteria

  • Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
  • Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Treatment and study plan

Counseling

Other

Professional Counseling is an activity that aims to improve the client's quality of life. Supporting his strengths and his ability to self-determination, Counseling offers a space for listening and reflection in which to explore difficulties, related to evolutionary processes, transition phase, states of crisis and reinforcement of the ability to choose or change.

Primary outcomes

  1. Gastrointestinal Symptom Rating Scale (GSCG)

    Time frame: 12 months

    Administration of psychometric scales

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 months

    Administration of psychometric scales

Secondary outcomes

  1. Psychological General Well-Being Index (PGWBI)

    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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