A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
Rheumatoid arthritis (RA) is a systemic chronic inflammatory disease, and depression and anxiety are among the most common comorbidities in RA patients, with a high prevalence rate. Epidemiological studies have found that joint deformities, severe pain, positive serum RF titers, as well as comorbidities such as hypertension, insomnia, pain, and fatigue are significantly associated with depression and anxiety in RA patients.
Currently, clinical studies have found that the relief of depression or anxiety is one of the expected treatment goals for RA patients. Due to the unclear pathogenic factors of depression or anxiety in RA patients, there is a lack of effective clinical treatment options. Therefore, this study will use a "causal inference model" to identify possible "mediating variables" that may lead to the comorbidity of RA and emotional disorders through clinical investigation, aiming to improve the precision of treatment for physicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with RA.
排除标准
- •Patients diagnosed as non-RA.
结局指标
主要结局
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Enrollment: January 2022 to May 2023
The GAD-7 scale is a commonly used self-assessment tool to evaluate the severity of generalized anxiety disorder. It consists of 7 items that correspond to common symptoms of generalized anxiety disorder, including excessive worry, nervousness, anxiety, irritability, difficulty concentrating, fatigue, and muscle tension. Similar to the PHQ-9, each item has four response options representing the frequency or severity of symptoms. The response options include "0" (not at all), "1" (several days), "2" (more than half the days), and "3" (nearly every day). By summing the scores of these 7 items, a total score is obtained to measure the severity of generalized anxiety disorder. The total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Enrollment: January 2022 to May 2023
The PHQ-9, one of the internationally recognized depression screening tools, consists of 9 items that correspond to common symptoms of depression, including depressed mood, loss of interest, sleep problems, fatigue, changes in appetite, self-evaluation issues, concentration difficulties, psychomotor problems, and suicidal thoughts. Each item has four response options representing the frequency or severity of symptoms, including "0" (not at all), "1" (several days), "2" (more than half the days), and "3" (nearly every day). By summing the scores of these 9 items, a total score is obtained to measure the severity of depression. The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
次要结局
- The Fatigue Self-Assessment Scale.(Enrollment: January 2022 to May 2023)
- Medication use(Enrollment: January 2022 to May 2023)
- Complications(Enrollment: January 2022 to May 2023)
- Body Mass Index(Enrollment: January 2022 to May 2023)
- Marital status(Enrollment: January 2022 to May 2023)
- Educational level(Enrollment: January 2022 to May 2023)
- Smoking history(Enrollment: January 2022 to May 2023)
- Disease Activity Score 28(Enrollment: January 2022 to May 2023)
- The Pittsburgh Sleep Quality Index (PSQI)(Enrollment: January 2022 to May 2023)
- Alcohol history(Enrollment: January 2022 to May 2023)
- Surgical history(Enrollment: January 2022 to May 2023)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Enrollment: January 2022 to May 2023)
- Financial status(Enrollment: January 2022 to May 2023)
- Labor intensity based on the 2000 Chinese Nutrition Society's classification standard(Enrollment: January 2022 to May 2023)
- White blood cell count (cells/μL)(Enrollment: January 2022 to May 2023)
- Anti-cyclic citrullinated peptide antibody (U/mL)(Enrollment: January 2022 to May 2023)
- Hypersensitive C-reactive protein (mg/L)(Enrollment: January 2022 to May 2023)
- Rheumatoid factor (IU/ml)(Enrollment: January 2022 to May 2023)
- Erythrocyte sedimentation rate (mm/h)(Enrollment: January 2022 to May 2023)
- Anti-nuclear antibodies(Enrollment: January 2022 to May 2023)
研究者
Shate Xiang
Principal Investigator
Zhejiang Chinese Medical University