NCT03061877

Brief Summary

Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This study is to investigate the effect of anxiety and depression on treatment response in people with RA using observational longitudinal study design.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

February 20, 2017

Last Update Submit

September 18, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Clinical remission

    Clinical remission defined by the Disease Activity Score 28 (DAS28) with a score less than 2.6

    6 months

Study Arms (2)

Anxiety or depression

Other: Anxiety or depression

Non-anxiety or depression

Interventions

Anxiety or depressionOTHER

The presence of anxiety or depression measured by the Hospital Anxiety and Depression Scale (HAD)

Anxiety or depression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People diagnosed with rheumatoid arthritis according to American College Rheumatology (ACR) criteria 2010

You may qualify if:

  • People diagnosed with rheumatoid arthritis according to the American College Rheumatology (ACR) criteria 2010

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidAnxiety DisordersDepression

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kun Zou, PhD

    Sichuan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Zou, PhD

CONTACT

86 028-87393972zoukun.jy@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 23, 2017

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

September 19, 2018

Record last verified: 2018-09