Spiritual Needs of European Patients With Inflammatory Bowel Disease and Their Caregivers

A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology \[3\] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.

NCT Number	NCT07020481
Lead Sponsor	University of Padova
Conditions	Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Enrollment	1,000 participants
Start Date	2025-09
Primary Completion	2025-12 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-13