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临床试验/NCT06713694
NCT06713694尚未招募不适用

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

Wang Zhen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
mood

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

mood

时间窗: 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.

次要结局

  • stigma(From enrollment to the end of treatment at 6 weeks)

研究者

发起方
Wang Zhen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wang Zhen

Clinical Reaserch Nurse

Zhejiang University

研究点 (1)

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