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Not yet recruiting NCT06713694

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

No phase Interventional Inflammatory Bowel Disease (IBD) Cognitive Behavior Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive-behavioral therapy, Wait first, then cognitive-behavioral therapy.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD), Cognitive Behavior Therapy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effectiveness of Cognitive Behavioral Therapy on Anxiety, Depression, and Stigma Among Chinese Patients With Inflammatory Bowel Disease Across Diverse Cultural Identities:Protocol for a Pilot Randomised Controlled Trial

Overview

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 .

Interventions

  • Other cognitive-behavioral therapy
    The treatment will consist of eight weekly sessions, each lasting one hour. The first session will focus on the rationale of cognitive behavioral therapy, i.e. the influence of (irrational or dysfunctional) cognitions and attitudes on (restrictive) feelings and behaviors. Additionally, goal setting will be initiated. Since patients may have a wide diversity of psychiatric problems (i.e. PTSD, anxiety disorders and depression), the treatment manual will encompass five optional modules for the the
  • Other Wait first, then cognitive-behavioral therapy
    participants assigned to the waiting-list control condition will wait 3.5 months before they are treated with CBT. This period corresponds to the duration of the CBT intervention and follow-up assessment of the experimental group. After this 3.5 month waiting period the participants in the waiting-list control condition will be asked to complete a follow-up after waiting/baseline before CBT assessment before starting treatment.

Primary outcome measures

  • mood [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (1)
  • stigma [Time frame: From enrollment to the end of treatment at 6 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou

Publications

  • Wang Z, Dong D, Yao L, Liu J, Zhan S, Wei M, Shao J, Luo H. Study protocol: Feasibility and acceptability of culturally adapted CBT for anxiety, depression, and stigma in Chinese IBD patients. Acta Psychol (Amst). 2026 Apr 16;266:106787. doi: 10.1016/j.actpsy.2026.106787. Online ahead of print. PMID 41997070

Identifiers

NCT: NCT06713694 · ZJSRRSH202479337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗