Clinical trial NCT05892562: A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis
Official title: A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Anxiety
Depression
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital of Zhejiang University
First posted: 2023-06-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with RA.

Exclusion Criteria:

* Patients diagnosed as non-RA.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Enrollment: January 2022 to May 2023
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Enrollment: January 2022 to May 2023
Secondary outcomes:
measure: Body Mass Index
timeFrame: Enrollment: January 2022 to May 2023
measure: Marital status
timeFrame: Enrollment: January 2022 to May 2023
measure: Educational level
timeFrame: Enrollment: January 2022 to May 2023
measure: Financial status
timeFrame: Enrollment: January 2022 to May 2023
measure: Smoking history
timeFrame: Enrollment: January 2022 to May 2023
measure: Disease Activity Score 28
timeFrame: Enrollment: January 2022 to May 2023
measure: Labor intensity based on the 2000 Chinese Nutrition Society's classification standard
timeFrame: Enrollment: January 2022 to May 2023
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Enrollment: January 2022 to May 2023
measure: The Fatigue Self-Assessment Scale.
timeFrame: Enrollment: January 2022 to May 2023
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Enrollment: January 2022 to May 2023
measure: Complications
timeFrame: Enrollment: January 2022 to May 2023
measure: Medication use
timeFrame: Enrollment: January 2022 to May 2023
measure: Alcohol history
timeFrame: Enrollment: January 2022 to May 2023
measure: Surgical history
timeFrame: Enrollment: January 2022 to May 2023
measure: Erythrocyte sedimentation rate (mm/h)
timeFrame: Enrollment: January 2022 to May 2023
measure: White blood cell count (cells/μL)
timeFrame: Enrollment: January 2022 to May 2023
measure: Anti-nuclear antibodies
timeFrame: Enrollment: January 2022 to May 2023
measure: Anti-cyclic citrullinated peptide antibody (U/mL)
timeFrame: Enrollment: January 2022 to May 2023
measure: Hypersensitive C-reactive protein (mg/L)
timeFrame: Enrollment: January 2022 to May 2023
measure: Rheumatoid factor (IU/ml)
timeFrame: Enrollment: January 2022 to May 2023
Other outcomes:
measure: weight
timeFrame: Enrollment: January 2022 to May 2023
measure: height
timeFrame: Enrollment: January 2022 to May 2023
measure: Visual Analogue Scale
timeFrame: Enrollment: January 2022 to May 2023
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang Chinese Medical University
state: None Selected
Study officials:
References: