Anxiety, Depression, Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Depression, Anxiety, DAS28, HADS
Brief summary
The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs
Detailed description
The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit
Interventions
Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire
Sponsors
University of Pavia
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria * being able to compile questionnaire * current treatment with biological disease-modifying antirheumatic drug
Exclusion criteria
* Current treatment for anxiety or depressive disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | 1 day of enrollement | Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients RA-BIO Patients with rheumatoid arthritis treated with biological drugs | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Patients RA-BIO |
|---|---|
| Age, Continuous | 62.35 years |
| Disease Activity Score on 28 joints (DAS28) | 3.01 units on a scale STANDARD_DEVIATION 1.07 |
| Disease Duration | 11.24 years |
| Region of Enrollment Italy | 200 participants |
| Sex: Female, Male Female | 171 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Time frame: 1 day of enrollement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients RA-BIO | Hospital Anxiety and Depression Scale (HADS) | ANXIETY | 46 participants |
| Patients RA-BIO | Hospital Anxiety and Depression Scale (HADS) | DEPRESSION | 20 participants |
| Patients RA-BIO | Hospital Anxiety and Depression Scale (HADS) | ANXIETY/DEPRESSION | 27 participants |
| Patients RA-BIO | Hospital Anxiety and Depression Scale (HADS) | HEALTHY | 107 participants |