A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
Not applicable · Testing Online Positive Psychology Intervention and Routine Care · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Online Positive Psychology Intervention (a behavioral program) and Routine Care as supportive care (to help with symptoms or quality of life). Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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);
Plus 3 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-05-01.
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- GAD-7 (Measurements will be conducted at four time points: prior to the intervention, at the end of Week 3 of the…)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Collaborators | Zhejiang University; Shaoxing Central Hospital |
| Enrollment | 120 (estimated) |
| Start date | 2025-05-01 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2025-04-23 |
| Last updated | 2025-07-15 |
| 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 |
Interventions
- Online Positive Psychology Intervention (Behavioral)
A 6-week online psychological support program, held once a week, primarily organized by a facilitator, with patient-led discussions and communication. - Routine Care (Other)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou | Hangzhou, Zhejiang | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.