The Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease
Not applicable · Testing cognitive-behavioral therapy and Wait first, then cognitive-behavioral therapy · 1 site · Wang Zhen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing cognitive-behavioral therapy and Wait first, then cognitive-behavioral therapy as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Disease (IBD) and Cognitive Behavior Therapy.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-08-01 (planned).
- Main results expected around 2026-12-30 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- mood (From enrollment to the end of treatment at 8 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Cognitive Behavior Therapy |
| Lead sponsor | Wang Zhen |
| Enrollment | 40 (estimated) |
| Start date | 2025-08-01 |
| Primary completion (est.) | 2026-12-30 |
| First posted | 2024-12-03 |
| Last updated | 2025-04-16 |
| 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 |
| ClinicalTrials.gov ID | NCT06713694 |
Interventions
- cognitive-behavioral therapy (Other)
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, anxi… - Wait first, then cognitive-behavioral therapy (Other)
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 assess…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Hangzhou, Zhejiang | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.