Exploring spiritual needs in inflammatory bowel disease: a qualitative study protocol adopting the think-aloud method

Background: Spirituality may influence coping and quality of life in inflammatory bowel disease (IBD), yet spiritual needs are rarely assessed systematically in routine care. The Spiritual Needs Questionnaire - Extended Version (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) explore spiritual needs and illness meanings but require cross-cultural adaptation and content validation for use in the Italian IBD context. Methods: This protocol describes a qualitative questionnaire validation study using think-aloud cognitive interviews. Purposive sampling with planned heterogeneity and saturation-based stopping will be used to recruit adult IBD patients and healthcare professionals from two Italian IBD outpatient centers. Participants will complete the Italian versions of the questionnaires while verbalizing their thoughts, followed by retrospective probing guided by Tourangeau's cognitive model and a brief debriefing. Interviews will be audio-recorded, anonymized, and analyzed item-by-item in a matrix using predefined problem codes complemented by inductive coding. Inter-coder reliability will be assessed on a subset of transcripts; AI-assisted coding will be explored using de-identified text under human oversight. Results: As this manuscript represents a research protocol, no empirical results have been generated at this stage. This protocol describes a structured approach to evaluating the content validity of two questionnaires, emphasizing transparency in translation, cognitive testing, and item-revision decision rules. The combined use of concurrent think-aloud and retrospective probing will enable observation of real-time cognitive processes and clarification of ambiguous responses. The inclusion of both patients and healthcare professionals will provide complementary perspectives. The exploratory use of AI-assisted coding may offer efficiencies for segment classification in large item-by-item matrices. Conclusions: Rigorously adapted and content-validated Italian versions of the SpNQ-EV and IIQ may support both research and clinical practice by providing a shared language for exploring existential and spiritual dimensions of living with IBD, supporting future psychometric validation and implementation of spiritual and interpretation of illness assessment.