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A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-15
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Crohn's disease is a chronic inflammatory condition affecting the digestive tract, often causing persistent symptoms and relapses that impact patients' mental health and quality of life. This study evaluates the effects of an online positive psychological intervention designed to enhance patients' positive emotions, cognition, and behaviors to better manage stress and adversity associated with Crohn's disease. The goal is to help patients cope more effectively and potentially improve their overall well-being. Participants in this trial will be randomly assigned to one of two groups. The intervention group will engage in a six-week online psychological support program with weekly sessions led by trained facilitators and involving patient-led discussions. The control group will receive routine care, including health education from IBD specialists and nurses covering disease knowledge, medication, diet, exercise, lifestyle, psychological support, and follow-up care. Both groups will be connected via WeChat groups for study communication. Throughout the study, assessments will be conducted using the GAD-7 anxiety scale at four points: before the intervention, at weeks three and six of the intervention, and three months after completion. Data collection will be managed by nursing staff and graduate students to monitor participant progress and outcomes. The total study duration includes the six-week intervention period and a three-month follow-up to evaluate lasting effects on mental health and quality of life.
CONDITIONS
Brief Title
A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Crohn's disease by the 2018 Chinese Medical Association criteria
- Patients aged between 18 and 75 years
- Patients with mild to moderate anxiety or depression (GAD-7 or PHQ-9 score 5-14)
- Patients who understand and agree to study requirements and have signed consent
- Patients able to read, access the internet, use WeChat and mobile apps independently or with family help
- Patients able to complete all training and follow-up procedures
You will not qualify if you...
- History or current diagnosis of psychiatric illness or cognitive impairment, or currently taking psychiatric medications
- Individuals working in psychology or with prior or current study of positive psychology
- Patients with other intestinal diseases or malignancies
- Patients with severe cardiovascular, cerebrovascular, liver, or kidney diseases
- Patients lost to follow-up or developing severe complications preventing study continuation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online) to assess eligibility and obtain consent
Duration - 6 weeks
Participants in the intervention group participate in a 6-week online positive psychological support program with weekly facilitated sessions. Participants in the control group receive routine health education by specialists and nurses tailored to their needs during follow-up visits.
Weekly visits (online sessions for intervention group; follow-up visits for control group)
Duration - 3 months
Participants complete assessments to monitor mental health and quality of life up to three months after the intervention ends.
1 visit three months after the intervention ends (online or in-person)
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Hangzhou, Zhejiang, China, 310009
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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