NCT02257073

Brief Summary

To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

October 2, 2014

Last Update Submit

March 31, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks

    at 0 week, 12 weeks, 24 weeks, 48 weeks

Study Arms (2)

CBT

EXPERIMENTAL

Cognitive-behavioral treatment

Behavioral: Cognitive-behavioral treatment

WLT

SHAM COMPARATOR

Waiting in list

Behavioral: Waiting List

Interventions

Cognitive-behavioral treatmentBEHAVIORAL
CBT
Waiting ListBEHAVIORAL
WLT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed by rheumatology consultants with RA

You may not qualify if:

  • severe psychological difficulties
  • currently receiving mental health care
  • any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
  • previously attended an education programme
  • had a Modified Health Assessment Questionnaire score \>2 (score range 0-3), that is severe functional problems
  • history of organic brain syndrome
  • presence of a psychotic disorder
  • presence of other uncontrolled medical disorders
  • presence of a major communication disorder, illiteracy
  • presence of less than an 8th grade education (due to inability to complete questionnaires)
  • presence of a therapeutic dosage of an antidepressant medication, or presence of another autoimmune disease/disabling condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2018

Study Completion

July 1, 2020

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)