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

NCT05892562 | Unknown

• 1 other identifier: Shate Xiang
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (20)

• 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

• Financial status

  Enrollment: January 2022 to May 2023

• Smoking history

  Enrollment: January 2022 to May 2023

Other Outcomes (3)

• weight

  Enrollment: January 2022 to May 2023

• height

  Enrollment: January 2022 to May 2023

• Visual Analogue Scale

  Enrollment: January 2022 to May 2023

Study Arms (2)

RA combined with depression or anxiety

Other: No intervention

RA without comorbid depression or anxiety

Other: No intervention

Interventions

No intervention OTHER

As this study is purely observational, no intervention is involved.

RA combined with depression or anxiety; RA without comorbid depression or anxiety

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population consists of patients diagnosed with RA in clinical settings, who were assessed for their mental status using PHQ-9 and GAD-7, and classified as either RA patients with comorbid depression or RA patients without comorbid depression.

You may qualify if:

• Patients diagnosed with RA.

You may not qualify if:

• Patients diagnosed as non-RA.

Sponsors & Collaborators

• Shate Xiang: lead
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, None Selected, 310053, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Shate Xiang, Master's degree

CONTACT

15157147753; xiangshate@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: June 7, 2023
• Study Start: December 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)