A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis

Depression Clinical Trial

Official title:

A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892562
• Other study ID #: Shate Xiang
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: June 2023
• Source: Zhejiang Chinese Medical University
• Contact: Shate Xiang, Master's degree
• Phone: 15157147753
• Email: xiangshate[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with RA.

Exclusion Criteria:

• Patients diagnosed as non-RA.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Arthritis
• Arthritis, Rheumatoid
• Depression
• Depressive Disorder
• Rheumatoid Arthritis

Intervention

Other:
• No intervention
As this study is purely observational, no intervention is involved.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	None Selected

Sponsors (2)

Lead Sponsor	Collaborator
Shate Xiang	First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight	weight in kilograms	Enrollment: January 2022 to May 2023
Other	height	height in meters	Enrollment: January 2022 to May 2023
Other	Visual Analogue Scale	VAS (Visual Analog Scale) is a pain assessment scale that uses a ruler divided into 10 equal parts. A score of 0 represents no pain, while a score of 10 represents the highest level of pain.	Enrollment: January 2022 to May 2023
Primary	Patient Health Questionnaire-9 (PHQ-9)	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.	Enrollment: January 2022 to May 2023
Primary	Generalized Anxiety Disorder-7 (GAD-7)	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.	Enrollment: January 2022 to May 2023
Secondary	Body Mass Index	The Body Mass Index (BMI) is a commonly used measure of body weight in relation to height. It is calculated by dividing a person's weight in kilograms by the square of their height in meters. The formula for calculating BMI is: BMI = weight (kg) / height (m)^2; Based on the calculated value, BMI categorizes individuals into different weight ranges. The commonly used classification criteria are as follows: BMI < 18.5: Underweight 18.5 = BMI < 24.9: Normal weight 25 = BMI < 29.9: Overweight BMI = 30: Obesity	Enrollment: January 2022 to May 2023
Secondary	Marital status	We categorized the marital status of the study population into three major groups: married, unmarried, and divorced.	Enrollment: January 2022 to May 2023
Secondary	Educational level	We categorized the educational level of the study population into three categories: primary school or below, junior high school or high school, and college or above.	Enrollment: January 2022 to May 2023
Secondary	Financial status	We classified the patients' satisfaction with their current economic situation into three categories: comfortable, manageable, and challenging.	Enrollment: January 2022 to May 2023
Secondary	Smoking history	Smoking history: Never smoked, Former smoker, Current smoker.	Enrollment: January 2022 to May 2023
Secondary	Disease Activity Score 28	DAS28 (Disease Activity Score 28) is a scale used to assess the activity level of rheumatoid arthritis (RA). It is calculated based on the assessment of joint swelling, joint tenderness, systemic inflammatory markers (erythrocyte sedimentation rate), and the patient's self-assessment of pain using a visual analog scale (VAS). The specific formula for calculating DAS28 (Disease Activity Score 28) is as follows: DAS28 = 0.56 * v(TJC28) + 0.28 * v(SJC28) + 0.36 * ln(CRP) + 0.014 * GH + 0.96 The DAS28 calculation includes the examination of 28 joints, including the fingers and wrists, elbows, shoulders, knees, and ankles. The DAS28 score ranges from 0 to 10, with higher scores indicating higher disease activity. Common classification criteria include low disease activity (DAS28 < 3.2), moderate disease activity (3.2 = DAS28 < 5.1), and high disease activity (DAS28 = 5.1).	Enrollment: January 2022 to May 2023
Secondary	Labor intensity based on the 2000 Chinese Nutrition Society's classification standard	Light physical activity: Refers to activities such as prolonged standing or walking, office work, light household chores, etc.; Moderate physical activity: Refers to activities that involve more walking, standing work, moderate household chores, farming, and light physical work.; Heavy physical activity: Refers to activities such as prolonged walking or running, heavy physical work, sports athletes, and other high-intensity activities.	Enrollment: January 2022 to May 2023
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	The Health Assessment Questionnaire Disability Index (HAQ-DI) is a commonly used scale for assessing the level of functional disability in patients' daily activities. It covers various activities such as getting up, dressing, bathing, eating, walking, and climbing stairs. Patients are required to rate each item based on their actual abilities to reflect their level of functional impairment. The scoring typically ranges from 0 to 3, with 0 indicating no functional disability and 3 indicating severe functional impairment.The minimum value is 0, and the maximum value is 60.; By calculating the total score of HAQ-DI, the quantified assessment of patients' daily life functioning can be obtained. This index can be used to evaluate treatment effectiveness, disease progression, and quality of life changes in patients.; Note that HAQ-DI is not only used for assessing patients with rheumatoid arthritis but can also be applied to functional assessment in other chronic diseases.	Enrollment: January 2022 to May 2023
Secondary	The Fatigue Self-Assessment Scale.	The Fatigue Self-Assessment Scale (FSAS) is developed based on a review of research on fatigue assessment both domestically and internationally, taking into account Chinese language habits and cultural characteristics. The scale consists of 23 items and is used to assess the types and severity of fatigue in sub-healthy individuals and various patient populations with fatigue-related symptoms. It includes three factors: physical fatigue, mental fatigue, and consequences of fatigue. It also evaluates three characteristics of fatigue: response to sleep/rest, situational factors, and temporal patterns. The scale can be used to assess the effectiveness of interventions targeting fatigue. The minimum score is 0, and the maximum score is 88, with higher scores indicating greater levels of fatigue.	Enrollment: January 2022 to May 2023
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess an individual's sleep quality and disturbances over a one-month time period. It consists of 19 items that cover several aspects of sleep, including sleep duration, sleep latency, sleep disturbances, use of sleep medications, and daytime dysfunction. The questionnaire is scored on a 0 to 3 scale for each item. The total score ranges from 0 to 21, with a higher score indicating worse sleep quality. The PSQI is commonly used in research and clinical settings to evaluate sleep problems and monitor treatment outcomes.	Enrollment: January 2022 to May 2023
Secondary	Complications	For example, hypertension, diabetes, Sjogren's syndrome, etc. We do not document diseases that have been treated with surgical procedures, such as uterine fibroids that have been removed.	Enrollment: January 2022 to May 2023
Secondary	Medication use	Mainly record the medication used by patients to treat rheumatoid arthritis in the past half month. For example, methotrexate, leflunomide, hydroxychloroquine, etc	Enrollment: January 2022 to May 2023
Secondary	Alcohol history	Alcohol history: Never drank, Former drinker, Current drinker.	Enrollment: January 2022 to May 2023
Secondary	Surgical history	Surgical history: No history of surgery, History of surgery.	Enrollment: January 2022 to May 2023
Secondary	Erythrocyte sedimentation rate (mm/h)	Erythrocyte sedimentation rate (ESR) is a blood test that measures the rate at which red blood cells settle in a vertical tube over a specific period of time. It is a non-specific marker of inflammation and is commonly used as a screening test to assess the presence and severity of inflammatory conditions in the body.	Enrollment: January 2022 to May 2023
Secondary	White blood cell count (cells/µL)	White blood cell count, also known as leukocyte count, is a blood test that measures the number of white blood cells (leukocytes) present in a specified volume of blood. White blood cells are an essential part of the immune system.	Enrollment: January 2022 to May 2023
Secondary	Anti-nuclear antibodies	When the test result is negative or 1:20, we consider it negative. When the result is 1:40, we consider it weakly positive. When the result is 1:60 or higher, we consider it positive.	Enrollment: January 2022 to May 2023
Secondary	Anti-cyclic citrullinated peptide antibody (U/mL)	Anti-cyclic citrullinated peptide antibody (anti-CCP antibody) is a type of autoantibody that targets the synthetic cyclic citrullinated peptide (CCP) antigen. It has high sensitivity and specificity for rheumatoid arthritis (RA), making it a highly specific marker for early diagnosis of RA. Furthermore, patients who test positive for this antibody are more likely to develop severe joint damage compared to those who test negative for the antibody.	Enrollment: January 2022 to May 2023
Secondary	Hypersensitive C-reactive protein (mg/L)	Hypersensitivity C-reactive protein (hsCRP) is a highly sensitive blood biomarker for measuring C-reactive protein levels. It is measured in milligrams per liter (mg/L). The level of hsCRP in the blood reflects the level of inflammation in the body.	Enrollment: January 2022 to May 2023
Secondary	Rheumatoid factor (IU/ml)	Rheumatoid factor (RF) is an autoantibody that targets the Fc portion of immunoglobulin G (IgG) antibodies. It is measured in international units per milliliter (IU/ml). Elevated levels of RF in the blood are commonly associated with rheumatoid arthritis (RA) and other autoimmune conditions. The presence of RF in the blood indicates an immune system response and can contribute to the diagnosis and management of RA.	Enrollment: January 2022 to May 2023