A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients

July 10, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Positive Psychology Intervention Group
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.
Behavioral: Online Positive Psychology Intervention
A 6-week online psychological support program, held once a week, primarily organized by a facilitator, with patient-led discussions and communication.
Placebo Comparator: Routine Care Group
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.
Other: Routine Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Zhejiang University
Shaoxing Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0629IR2024327

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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