Depression and Anxiety in Rheumatoid Arthritis (DEAR)

August 16, 2016 updated by: Vittorio Grosso, University of Pavia

Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • IRCCS policlinico San Matteo - Reparto di Reumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with rheumatoid arthritis currently treated with biological drugs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
1 day of enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Study Director: Roberto Caporali, MD, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31748\2009 progetto lorhen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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