Clinical trial NCT06713694: The Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Cognitive Behavior Therapy
Keywords: inflammatory bowel disease
cognitive behavior therapy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be divided into high and low groups based on the results of the Chinese Confucian coping Thinking Scale assessment. After completion of the first baseline assessment, patients will be randomly assigned to the experimental or waiting-list control condition.Randomization will be stratified by gender, disease type and will be conducted by an off-site statistician not involved in patient recruitment or assessment, using random allocation software.Participants assigned to the experimental condition will start treatment as soon as possible (maximum within 6 weeks). The second, mid-treatment assessment will take place four weeks following start of treatment and the third assessment one month following completion of treatment. Following the first baseline assessment, participants assigned to the waiting-list control condition will wait 3.5 months, then they will be asked to complete a follow-up assessment after waiting/baseline before they are treated with CBT.
Primary purpose: SUPPORTIVE_CARE

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: mood
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: stigma
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: