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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05752344
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystitis, Interstitial	Other: Counseling

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: Nov 1, 2022

Outcome Measures

Primary Outcome Measures

1. Gastrointestinal Symptom Rating Scale (GSCG) [12 months]

   Administration of psychometric scales

2. Hospital Anxiety and Depression Scale (HADS) [12 months]

   Administration of psychometric scales

Secondary Outcome Measures

1. Psychological General Well-Being Index (PGWBI) [12 months]

   Administration of psychometric scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli IRCCS	Rome	Roma	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mazza Marianna, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05752344
• Other Study ID Numbers: 3499
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial

Study Results

No Results Posted as of Mar 2, 2023