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

NCT05752344 | Completed

• 1 other identifier: 3499
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystitis, Interstitial

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal Symptom Rating Scale (GSCG)

  Administration of psychometric scales

  12 months

• Hospital Anxiety and Depression Scale (HADS)

  Administration of psychometric scales

  12 months

Secondary Outcomes (1)

• Psychological General Well-Being Index (PGWBI)

  12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 will accept to be subjected to remote monitoring and diagnostic investigation as per the proposed scheme.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, ROMA, 00168, Italy

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Counseling

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 2, 2023
• Study Start: November 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)