Crohn DiseaseNCT06939712
A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
A study testing Online Positive Psychology Intervention and Routine Care in people with Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Crohn's disease (CD) is a chronic, nonspecific inflammatory disease that can affect the entire digestive tract. It is difficult to cure and often relapses, causing long-term suffering for patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Online Positive Psychology Intervention and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Apr 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Crohn's disease according to the 2018 diagnostic criteria established by the Inflammatory Bowel Disease Group of the Chinese Medical Association's Gastroenterology Branch;
- Patients aged between 18 and 75 years;
- Patients with a score of 5-14 on the GAD-7 (indicative of mild to moderate anxiety) or a score of 5-14 on the PHQ-9 (indicative of mild to moderate depression);
- Patients who understand and agree to comply with the study requirements and have signed informed consent;
- Patients who are able to read and access the internet, either independently or with assistance from a family member, and are capable of using WeChat and mobile applications;
- Patients who are able to complete all course trainings and/or follow-up procedures.
Who cannot join
- Individuals with a history or current diagnosis of psychiatric illness or cognitive impairment, or those currently taking psychiatric medications; Individuals working in the field of psychology, or those who have previously studied or are currently studying positive psychology;
- Individuals with concurrent other intestinal diseases or malignancies;
- Individuals with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, or renal systems.
- Withdrawal Criteria:
- Patients lost to follow-up due to withdrawal or other reasons during the intervention period;
- Patients who develop severe complications or experience significant changes in their condition that prevent them from continuing the study.
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Hangzhou, Zhejiang, 310009
Shuyan LI Shuyan Li, 86+13758142153, lishuyan@zju.edu.cn
About this study
Crohn's disease (CD) is a chronic, nonspecific inflammatory disease that can affect the entire digestive tract. It is difficult to cure and often relapses, causing long-term suffering for patients. This persistent condition significantly impacts their mental and psychological well-being, leading to a noticeable decline in their quality of life. Furthermore, these negative emotions can contribute to disease recurrence and the worsening of symptoms. Positive psychological intervention (PPI) refers to the enhancement of positive emotions, cognition, and behaviors to increase well-being and alleviate symptoms. Therefore, this study aims to use psychological methods to help CD patients better recognize and understand their positive experiences, thus aiding them in coping with stress and adversity more effectively.
- Conditions
- Crohn Disease
- Being tested
- Online Positive Psychology Intervention, Routine Care
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Positive Psychology InterventionBehavioural
A 6-week online psychological support program, held once a week, primarily organized by a facilitator, with patient-led discussions and communication.
Routine CareOther
A 6-week program of health education provided by IBD specialists and nurses during patient follow-ups, tailored to individual patient circumstances and needs. Topics include IBD disease knowledge, medication management, diet, exercise, lifestyle, psychological support, and follow-up care. Patients in this group will also join a control group WeChat group for study-related communication.
| Study group | Role | What they receive |
|---|---|---|
| Online Positive Psychology Intervention Group | Experimental | Intervention group patients will participate in a 6-week online psychological support program, held once a week. The sessions will primarily be organized by a facilitator and will include patient-led discussions and communication. The specialized nurse will add the patients to the corresponding WeChat group and collect general information about the research subjects. A nursing graduate student (blinded) will collect data before the intervention, at the end of the third week of the intervention, at the end of the sixth week of the intervention, and three months after the end of the intervention. Five group leaders, all trained in a standardized manner, will carry out interventions according to the intervention plan and content for the patients in the intervention group. IBD specialists and nurses will implement routine patient management. Receives: Behavioral: Online Positive Psychology Intervention |
| Routine Care Group | Placebo comparator | The IBD specialists and nurses will primarily provide health education on IBD disease knowledge, medication, diet, exercise, lifestyle, psychological well-being, and follow-up care based on the patient's actual situation and individual needs during patient follow-up visits. At the same time, patients will be added to the control group WeChat group. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD-7
indicative of mild to moderate anxiety
Measured: Measurements will be conducted at four time points: prior to the intervention, at the end of Week 3 of the intervention, at the end of Week 6 of the intervention, and three months after the intervention concludes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Shaoxing Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939712
- Sponsor's protocol ID
- 2024-0629IR2024327
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT06939712
- Acronym / sponsor ID
- 2024-0629IR2024327
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University, Shaoxing Central Hospital
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 23 Apr 2025 (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.
Crohn's disease (CD) is a chronic, nonspecific inflammatory disease that can affect the entire digestive tract. It is difficult to cure and often relapses, causing long-term suffering for patients. This persistent condition significantly impacts their mental and psychological well-being, leading to a noticeable decline in their quality of life. Furthermore, these negative emotions can contribute to disease recurrence and the worsening of symptoms. Positive psychological intervention (PPI) refers to the enhancement of positive emotions, cognition, and behaviors to increase well-being and alleviate symptoms. Therefore, this study aims to use psychological methods to help CD patients better recognize and understand their positive experiences, thus aiding them in coping with stress and adversity more effectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Positive Psychology Intervention Group | Experimental | Behavioral: Online Positive Psychology InterventionIntervention group patients will participate in a 6-week online psychological support program, held once a week. The sessions will primarily be organized by a facilitator and will include patient-led discussions and communication. The specialized nurse will add the patients to the corresponding WeChat group and collect general information about the research subjects. A nursing graduate student (blinded) will collect data before the intervention, at the end of the third week of the intervention, at the end of the sixth week of the intervention, and three months after the end of the intervention. Five group leaders, all trained in a standardized manner, will carry out interventions according to the intervention plan and content for the patients in the intervention group. IBD specialists and nurses will implement routine patient management. |
| Routine Care Group | Placebo comparator | Other: Routine CareThe IBD specialists and nurses will primarily provide health education on IBD disease knowledge, medication, diet, exercise, lifestyle, psychological well-being, and follow-up care based on the patient's actual situation and individual needs during patient follow-up visits. At the same time, patients will be added to the control group WeChat group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with Crohn's disease according to the 2018 diagnostic criteria established by the Inflammatory Bowel Disease Group of the Chinese Medical Association's Gastroenterology Branch;
- Patients aged between 18 and 75 years;
- Patients with a score of 5-14 on the GAD-7 (indicative of mild to moderate anxiety) or a score of 5-14 on the PHQ-9 (indicative of mild to moderate depression);
- Patients who understand and agree to comply with the study requirements and have signed informed consent;
- Patients who are able to read and access the internet, either independently or with assistance from a family member, and are capable of using WeChat and mobile applications;
Key exclusion criteria (6 listed)
- Individuals with a history or current diagnosis of psychiatric illness or cognitive impairment, or those currently taking psychiatric medications; Individuals working in the field of psychology, or those who have previously studied or are currently studying positive psychology;
- Individuals with concurrent other intestinal diseases or malignancies;
- Individuals with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, or renal systems.
- Patients lost to follow-up due to withdrawal or other reasons during the intervention period;
- Patients who develop severe complications or experience significant changes in their condition that prevent them from continuing the study.
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 |
|---|---|---|
| Online Positive Psychology InterventionA 6-week online psychological support program, held once a week, primarily organized by a facilitator, with patient-led discussions and communication. | Behavioural | Online Positive Psychology Intervention Group |
| Routine CareA 6-week program of health education provided by IBD specialists and nurses during patient follow-ups, tailored to individual patient circumstances and needs. Topics include IBD disease knowledge, medication management, diet, exercise, lifestyle, psychological support, and follow-up care. Patients in this group will also join a control group WeChat group for study-related communication. | Other | Routine Care Group |
Primary outcome
GAD-7
Time frame: Measurements will be conducted at four time points: prior to the intervention, at the end of Week 3 of the intervention, at the end of Week 6 of the intervention, and three months after the intervention concludes.
indicative of mild to moderate anxiety
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 15 Jul 2025.
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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.
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Positive Psychology Intervention and Routine Care in people with Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jul 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 (time frame: Measurements will be conducted at four time points: prior to the intervention, at the end of Week 3 of the intervention, at the end of Week 6 of the intervention, and three months after the intervention concludes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.