Depression and Anxiety in Rheumatoid Arthritis

NCT02122406 | Completed Results

• 1 other identifier: 31748\2009 progetto lorhen
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Depression; Anxiety

Keywords

Rheumatoid Arthritis; Depression; Anxiety; DAS28; HADS

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day of enrollement

Study Arms (1)

Patients RA-BIO

Patients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab)

Other: Hospital Anxiety and Depression Scale (HADS) questionnaire

Interventions

Hospital Anxiety and Depression Scale (HADS) questionnaire OTHER

Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire

Patients RA-BIO

Eligibility Criteria

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

Study Population

Adult patients with rheumatoid arthritis currently treated with biological drugs.

You may qualify if:

• 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

You may not qualify if:

• Current treatment for anxiety or depressive disorder

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

IRCCS policlinico San Matteo - Reparto di Reumatologia

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Depression; Anxiety Disorders

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Vittorio Grosso MD
• Organization: University of Pavia

vittorio.grosso@gmail.com

+393332605945

Study Officials

• Roberto Caporali, MD

  University of Pavia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 10, 2016
• Results First Posted: October 10, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)