NCT06939712 A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
| NCT ID | NCT06939712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT06939712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06939712 currently recruiting?
Yes, NCT06939712 is actively recruiting participants. Visit ClinicalTrials.gov or contact Second Affiliated Hospital, School of Medicine, Zhejiang University to inquire about joining.
Where is the NCT06939712 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06939712 clinical trial?
NCT06939712 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 120 participants.