Inflammatory Bowel Disease (IBD)NCT06713694
The Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease
A study testing cognitive-behavioral therapy and Wait first, then cognitive-behavioral therapy in people with Inflammatory Bowel Disease (IBD) and Cognitive Behavior Therapy, run by Wang Zhen at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Cognitive Behavior Therapy
- What is being tested?
- cognitive-behavioral therapy and Wait first, then cognitive-behavioral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals scheduled for major surgery in the next 3 months.
- Current psychological treatment.
- Individuals with severe schizophrenia/psychotic disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310058
Zhuang Yiyu, Docter, 0571-86070073, srrshec@126.com
About this study
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
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 .
- Being tested
- cognitive-behavioral therapy, Wait first, then cognitive-behavioral therapy
- Keywords
- inflammatory bowel disease, cognitive behavior therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral therapyOther
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 therapist that focus on each of these disorders (i.e. exposure based for anxiety and PTSD, behavioral activation for depression). The subsequent sessions (2-6) will target teaching the patient to identify and challenge dysfunctional cognitions and attitudes related to IBD. Each session will address specific illness-related cognitions. If possible, dysfunctional cognitions and attitudes will be replaced by helpful cognitions and attitudes.
Wait first, then cognitive-behavioral therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Other: cognitive-behavioral therapy |
| CBT-II | Experimental | Not described Receives: Other: cognitive-behavioral therapy |
| Wait-list | Other | Not described Receives: Other: Wait first, then cognitive-behavioral therapy |
| Wait-list-II | Other | Not described Receives: Other: Wait first, then cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mood
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
stigma
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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Zhen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Zhen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713694
- Sponsor's protocol ID
- ZJSRRSH202479337
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41997070
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- ZJSRRSH202479337
- Keywords
- inflammatory bowel disease, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wang ZhenUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Other: cognitive-behavioral therapy |
| CBT-II | Experimental | Other: cognitive-behavioral therapy |
| Wait-list | Other | Other: Wait first, then cognitive-behavioral therapy |
| Wait-list-II | Other | Other: Wait first, then cognitive-behavioral therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Individuals scheduled for major surgery in the next 3 months.
- Current psychological treatment.
- Individuals with severe schizophrenia/psychotic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral therapyThe 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 therapist that focus on each of these disorders (i.e. exposure based for anxiety and PTSD, behavioral activation for depression). The subsequent sessions (2-6) will target teaching the patient to identify and challenge dysfunctional cognitions and attitudes related to IBD. Each session will address specific illness-related cognitions. If possible, dysfunctional cognitions and attitudes will be replaced by helpful cognitions and attitudes. | Other | CBT, CBT-II |
| Wait first, then cognitive-behavioral therapyparticipants 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. | Other | Wait-list, Wait-list-II |
Primary outcome
mood
Time frame: 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.
1 secondary outcome
stigma
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 41997070Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-behavioral therapy and Wait first, then cognitive-behavioral therapy in people with Inflammatory Bowel Disease (IBD) and Cognitive Behavior Therapy, run by Wang Zhen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Zhen (+8615757118326, wangzhen79337@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mood (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.