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Inflammatory Bowel DiseasesNCT04939948

Multi-factor Analysis of Psychological Disorders in IBD Patients

An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Diseases
How many people
200 participants
Where
1 siteChina
Study dates
1 Jul 2021to 1 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Gastroenterology

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Multi-factor Analysis of Psychological Disorders in Patients With Inflammatory Bowel Disease

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.

Read the detailed description

Patients with IBD self-reported their disease activity using validated patient-based measures. For those with CD, the Harvey-Bradshaw Index (HBI) was utilized, and for patients with UC, the Patient-based Simple Clinical Colitis Activity Index (P-SSCAI) was employed. An HBI score greater than 4 or a P-SSCAI score of 5 or higher was classified as active disease, while an HBI score of 4 or lower or a P-SSCAI score below 5 indicated disease remission.

To assess health-related quality of life (HRQOL), participants completed the Short Health Scale (SHS), a 4-item self-management questionnaire validated for use in adult IBD patients. Each item corresponds to specific dimensions of HRQOL: symptoms, social function, disease-related worry, and general well-being. Responses were graded on a 100-mm visual analog scale, with scores ranging from 0 to 100, where higher scores represented worse HRQOL.

Participants' anxiety and depression levels were evaluated using the Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9)20,21. Each scale comprises 7 and 9 self-assessment items to gauge anxiety and depression, respectively. A score of GAD-7 ≥10 indicated severe anxiety symptoms, while a score of PHQ-9 ≥ 10 indicated severe depression symptoms.

The Pittsburgh Sleep Quality Index scale (PSQI) was employed to assess sleep quality, encompassing subjective sleep quality, latency, duration, efficiency, persistence, use of sleep drugs, and daytime dysfunction22. The total scores on this scale range from 0 to 21, with higher scores indicating poorer sleep quality.

Statistical analysis The survey data were collected and analyzed using IBM SPSS statistical software (version 25.0, Chicago, Illinois, USA). Quantitative data were expressed as mean and standard deviation or inter-quartile range, and group differences were compared using t-tests for normally distributed data or the Wilcoxon test for non-normally distributed data. Categorical data were presented as frequencies or percentages, and differences in frequencies between groups were assessed using the χ2 test or Fisher's exact test. The correlation between scores of GAD-7 or PHQ-9 and SHS total scores was examined using simple linear regression, and the results were presented with the coefficient R2. To study the independent effect of various variables on the quality of life (QOL), multiple regression analysis was applied. Initially, correlations between demographic and clinical variables such as age, gender, living conditions, disease status, employment, marital status, family history of IBD, GAD-7 scores, PHQ-9 scores, and SDS scores were explored using simple regression. Variables with a p-value of ≤ 0.05 in the simple regression analyses were then included in the multiple regression analysis. Odds ratios (OR), 95% confidence intervals (95% CI), and p-values were calculated for each independent variable. For all statistical tests, a two-sided p-value of 0.05 was considered the threshold for defining the level of significance.

Keywords
inflammatory bowel disease, psychological disorders
Medical subject headings
Inflammatory Bowel Diseases, Mental Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (1)
  1. assess the effects of mental disease on drug adherence

    assess the effects of mental disease on drug adherence such as anti-tumor necrosis factor (anti-TNF) therapy

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start1 Jul 2021
  3. Primary completion1 Sep 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939948
Sponsor's protocol ID
2021-0332
Status last verified
Jun 2021
First submitted
17 Jun 2021
Last updated
2 Aug 2023
Results posted
No

Publications

  • Hu S, Xu D, Zhu C, Wang Y, Li S, Chen Y, Wang C, Chen Y. Impact of anxiety, depression and online mindfulness on IBD patients' quality of life: a web-based cross-sectional survey and randomized pilot study. BMC Psychiatry. 2025 Nov 6;25(1):1063. doi: 10.1186/s12888-025-07426-7.

    PubMed 41199235

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess the effects of mental disease on risk of IBD-related adverse outcomes (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939948, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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