Depression and Anxiety in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis; Depression; Anxiety
• Interventions: Other: Hospital Anxiety and Depression Scale (HADS) questionnaire

• Registration Number: NCT02122406
• Lead Sponsor: University of Pavia

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-05-10
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Results First Posted: 2016-10-10
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients RA-BIO	Hospital Anxiety and Depression Scale (HADS) questionnaire	Patients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS policlinico San Matteo - Reparto di Reumatologia; 🇮🇹 Pavia, PV, Italy