Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs

February 21, 2026 updated by: Taner Dandinoğlu, Bursa City Hospital

Comparison of Coronavirus-Related Anxiety Levels in Patients Using Biologic and Conventional Disease-Modifying Antirheumatic Drugs

The COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. This observational study aims to compare coronavirus-related anxiety levels in patients using biologic disease-modifying antirheumatic drugs (bDMARDs) and those using conventional disease-modifying antirheumatic drugs (cDMARDs).

Adult patients followed at the rheumatology outpatient clinic were contacted by telephone. After verbal consent was obtained, participants completed a patient information form and the Coronavirus Anxiety Scale. Anxiety levels and pandemic-related experiences were compared between treatment groups.

Study Overview

Detailed Description

This observational cohort study was conducted at the Rheumatology outpatient clinic of Uludag University Faculty of Medicine. The study included adult patients diagnosed with rheumatic diseases who were receiving either biologic DMARDs (bDMARDs) or conventional DMARDs (cDMARDs).

During the COVID-19 pandemic period, patients were contacted by telephone and informed about the study. Verbal consent was obtained prior to data collection. Demographic and clinical characteristics were recorded using a structured patient information form.

Coronavirus-related anxiety was assessed using the validated Coronavirus Anxiety Scale. The primary objective was to compare anxiety scores between patients receiving biologic and conventional DMARD therapy. Secondary analyses explored patients' perceptions of infection risk and their experiences during the pandemic period.

No intervention, treatment modification, or additional clinical procedure was performed. The study design is observational, and all data were collected at a single time point.

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

    • Türkiye
      • Bursa, Türkiye, Turkey (Türkiye), 16600
        • Bursa City Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with established rheumatic diseases under treatment with biologic or conventional DMARD therapy who were actively followed at a tertiary care rheumatology outpatient clinic during the COVID-19 pandemic.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of rheumatic disease
  • Currently receiving biologic or conventional disease-modifying antirheumatic drugs (DMARDs)
  • Followed at the rheumatology outpatient clinic during the COVID-19 pandemic period
  • Provided verbal informed consent

Exclusion Criteria:

  • Age <18 years
  • Inability to complete telephone interview
  • Cognitive impairment preventing reliable questionnaire response
  • Refusal to participate

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biologic DMARD group (bDMARD)
Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs
Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.
Conventional DMARD group (cDMARD)
Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs
Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronavirus Anxiety Scale Score
Time Frame: Baseline
Anxiety level measured using the validated Coronavirus Anxiety Scale (CAS). The total score ranges from 0 to 20, with higher scores indicating greater coronavirus-related anxiety.
Baseline

Collaborators and Investigators

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

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 (Actual)

October 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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