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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

China · 1 center

• The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou — Hangzhou

Identifiers

NCT: NCT06939712 · 2024-0629IR2024327

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗