Study protocol: Feasibility and acceptability of culturally adapted CBT for anxiety, depression, and stigma in...

Inflammatory bowel disease (IBD) is associated with high anxiety, depression, and stigma in Chinese populations, where Western-centric cognitive behavioral therapy (CBT) often fails to align with Confucian values of familial interdependence. This protocol for a pilot randomized controlled trial (RCT) aims to evaluate the feasibility, acceptability, and preliminary efficacy of a Confucianism-adapted CBT (CA-CBT) for Chinese IBD patients.

Forty IBD patients from a single tertiary center in China via consecutive inpatient wards and outpatient clinics recruitment will be randomized to an 8-week culturally adapted CBT intervention or waitlist control. Eligibility criteria include confirmed IBD diagnosis, age ≥ 18 years, and proficiency in Chinese. The intervention incorporates Confucian principles into standard CBT modules, addressing stigma, maladaptive cognitions, and disease-related distress. Randomization will be organized by level of Confucian Coping score and type of disease using block allocation, with blinded outcome assessors.

Primary outcomes will include feasibility (attendance rate ≥ 70%, retention rate ≥ 80%) and acceptability (qualitative feedback on cultural relevance, scored 1-5). Secondary outcomes will be depression (PHQ-9), anxiety (GAD-7), stigma (Social Impact Scale, SIS), and inflammatory bowel disease questionnaire (IBDQ), which will be assessed at T0 (≤7 days pre-randomization), T1 (4 weeks post-randomization ±7 days), and T2 (8 weeks post-randomization ±7 days).

If found, CA-CBT is feasible and may enhance both psychological and physiological outcomes in Chinese IBD patients. Cultural integration addresses stigma and improves engagement, advocating for broader implementation in non-Western contexts. Larger trials with extended follow-up are warranted.

ClinicalTrials.gov (NCT06713694).