Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04939948 |
| Other study ID # |
2021-0332 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
