Anxiety Depression and Rheumatoid Arthritis | NCT03061877

Studies
Anxiety Depression and Rheumatoid Arthritis

NCT03061877

Sponsor

Sichuan Provincial People's Hospital

Status

Unknown status

Last Update Posted

Sep 19, 2018Actual

Enrollment

134Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Anxiety or depression

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2019Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Feb 20, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2018

Last Update Posted Date

Sep 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anxiety or depression			Other: Anxiety or depression
Non-anxiety or depression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anxiety or depression	Other	The presence of anxiety or depression measured by the Hospital Anxiety and Depression Scale (HAD)	Anxiety or depression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical remission	Clinical remission defined by the Disease Activity Score 28 (DAS28) with a score less than 2.6	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kun Zou, PhD	Contact	86 028-87393972		zoukun.jy@outlook.com

Overall Officials

Name	Affiliation	Role
Kun Zou, PhD	Sichuan Provincial People's Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073222	Patient Health Questionnaire

Ancestor Terms

ID	Term
D011795	Surveys and Questionnaires
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided