Online positive psychology program to improve mental health and quality of life in Crohn's disease
A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
This trial will try an online positive psychology program to improve mood and quality of life for adults with Crohn's disease who have mild to moderate anxiety or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06939712 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–75 with Crohn's disease and mild to moderate anxiety or depression (GAD-7 or PHQ-9 scores 5–14) will be enrolled and randomized to receive an online positive psychology intervention or routine care. The intervention is delivered via WeChat and mobile apps and uses structured exercises to increase positive emotions, thoughts, and behaviors. Eligible participants must be able to read, access the internet, and complete online sessions and follow-up assessments; those with psychiatric illness or current psychiatric medication use are excluded. Study outcomes focus on changes in mental health symptoms and quality of life over the follow-up period.
Who should consider this trial
Good fit: Adults aged 18–75 with Crohn's disease who have mild to moderate anxiety or depression (GAD-7 or PHQ-9 scores 5–14), can use WeChat or a mobile app, and can complete online sessions are ideal candidates.
Not a fit: People with severe psychiatric disorders, cognitive impairment, current psychiatric medication use, or those unable to access or use the required online tools are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce anxiety and depression symptoms and improve quality of life for people with Crohn's disease using a convenient online format.
How similar studies have performed: Similar positive psychology and internet-based mental health programs have shown modest benefits for mood and well-being in other chronic illness populations, but evidence specifically in Crohn's disease is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.