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

BACKGROUND

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.

METHODS/

DESIGN

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.

OUTCOMES: 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).

CONCLUSION

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.

TRIAL REGISTRATION: ClinicalTrials.gov (NCT06713694).