The Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Bowel Disease (IBD); Cognitive Behavior Therapy

• Registration Number: NCT06713694
• Lead Sponsor: Wang Zhen

Brief Summary

Introduction Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a chronic condition that affects the gastrointestinal tract and has a significant impact on patients' quality of life (QoL) and mental health(Barberio, Zamani et al. 2021). Cognitive behavioral therapy (CBT) has been recognized as a potential therapeutic approach to address the psychological comorbidities associated with IBD(Seaton, Hudson et al. 2024). However, the effectiveness of CBT in IBD is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes(Naeem 2019).

The effectiveness of CBT in IBD is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes . This has implications for the delivery of CBT in IBD care, as cultural beliefs and values can affect help-seeking behaviors and responses to treatment. Cultural factors are integral to the successful implementation of CBT in IBD care(Hinton and Patel 2017, Naeem, Sajid et al. 2023). Further research is needed to understand how cultural adaptations can enhance the efficacy of CBT for IBD patients from diverse backgrounds. It is essential to consider cultural nuances in the development and delivery of CBT to ensure that it is both effective and acceptable to patients with IBD across different cultures.

Objective: To identify gaps in the current understanding of the role of culture in CBT for IBD, including the variety of cultural contexts and IBD populations studied . To provide insights that can guide clinical practice in offering culturally competent CBT to IBD patients and inform policy decisions regarding mental health services for diverse populations with IBD .

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Start: 2025-08-01
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients over 18 years of age with diagnosed IBD.
2. Age: 18 years and older.
3. residing in China, able to verbally communicate and read in Chinese, with access to the internet to ensure participation in the online intervention.
4. Able to commit to attend the 6weekly sessions of 1 hours' duration.
5. No change in antidepressant medication (dose or type) within 3 months of trial onset.

Exclusion Criteria

1. Individuals scheduled for major surgery in the next 3 months.
2. Current psychological treatment.
3. Individuals with severe schizophrenia/psychotic disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mood	From enrollment to the end of treatment at 8 weeks	anxiety and depression Generalized Anxiety Disorder-7 Item Scale(GAD-7) and Patient Health Questionnaire-9 Scale (PHQ-9) assesses the possible presence of anxiety and depressive states. The GAD-7 and PHQ-9 is considered to be unbiased by the presence of somatic illness and is found to be reliable and valid . It consists of two sub-scales, anxiety and depression, both containing seven items.

Secondary Outcome Measures

Name	Time	Method
stigma	From enrollment to the end of treatment at 6 weeks	The Social Impact Scale (SIS) was used to evaluate stigma associated with wound malodor. The SIS is widely used in patients with chronic diseases and includes 24 items within four dimensions, social exclusion, economic discrimination, inner sense of shame, and social isolation, evaluated using a Likert4 method. Total possible score ranged from 24 points to 96 points, with higher scores associated with a greater perceived social impact.

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China