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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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