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.
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.
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.
- Conditions
- Inflammatory Bowel Diseases
- 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.
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)
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.
- First posted25 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-factor Analysis of Psychological Disorders in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04939948
- Acronym / sponsor ID
- 2021-0332
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel disease, psychological disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Cognitive function and educational level can cooperate to complete the scale; No history of digestive system disease or mental illness;
Key exclusion criteria (1 listed)
- Cognitive function and educational level could not cooperate to complete the scale; Failed to fill in all the scales effectively;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess the effects of mental disease on risk of IBD-related adverse outcomes
Time frame: 3 months
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
1 secondary outcome
assess the effects of mental disease on drug adherence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 41199235Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.