Multi-factor Analysis of Psychological Disorders in IBD Patients

NCT04939948 | Completed

• 1 other identifier: 2021-0332
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease IBD, including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory disease of the intestinal tract with unknown etiology. The mechanism includes environment, genetics, intestinal microecology and immunity. In recent years, the incidence of IBD in Asian countries has continued to rise, and the incidence of CD and UC in Guangzhou has reached 1.09/10 million and 2.05/10 million respectively. The patient suffers from the disease for a long time, which greatly affects the mentality and the quality of life. However, the mentality and quality of life of IBD patients have not received the attention they deserve, and research in this area is relatively lacking. The study by Lewis et al. found that among IBD patients, up to 1/3 of depression patients and 2/3 of anxiety patients were not diagnosed in time. This study conducted an Internet questionnaire survey on IBD patients diagnosed in the Department of Gastroenterology, the Second Affiliated Hospital of Zhejiang University School of Medicine, to learn about the patients 'mental and psychological state, to screen the risk factors of patients'mental and psychological diseases, and to understand the impact of mental and psychological factors on the quality of life and quality of IBD patients. The impact of the disease provides a scientific basis for the optimal treatment of IBD.

Conditions

Inflammatory Bowel Diseases

Keywords

inflammatory bowel disease; psychological disorders

Outcome Measures

Primary Outcomes (1)

• assess the effects of mental disease on risk of IBD-related adverse outcomes

  assess the effects of mental disease on risk of IBD-related adverse outcomes such as IBD-related hospitalization or surgery, new or recurrent corticosteroid use, switching to an alternative anti-TNF, or death

  3 months

Secondary Outcomes (1)

• assess the effects of mental disease on drug adherence

  3 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were age 18 years or older, able to provide informed consent, and had sufficient knowledge to complete written questionnaires and a structured clinical interview. Participants were required to have completed their Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV-TR Axis I Disorders (SCID) within 4 weeks of their enrollment visit date and to meet the DSM-IV criteria for a depression or anxiety disorder.

You may qualify if:

• Cognitive function and educational level can cooperate to complete the scale; No history of digestive system disease or mental illness;

You may not qualify if:

• Cognitive function and educational level could not cooperate to complete the scale; Failed to fill in all the scales effectively;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Gastroenterology

Hangzhou, Zhejiang, 310009, China

Location

Biospecimen

Retention: NONE RETAINED

not needed

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Mental Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 2, 2023

Record last verified: 2021-06

Locations

CN (1)