Cognitive-behavioral Treatment for Rheumatoid Arthritis

March 31, 2017 updated by: Yang Min, Chengdu PLA General Hospital
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • General Hospital of Chengdu Military Area Command PLA

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed by rheumatology consultants with RA

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT
Cognitive-behavioral treatment
Behavioral: Cognitive-behavioral treatment
Sham Comparator: WLT
Waiting in list
Behavioral: Waiting List

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

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

Sponsor

Chengdu PLA General Hospital

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

October 1, 2014

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBRA20140102
  • BWS11J067 (Other Grant/Funding Number: "Twelfth Five-Year Plan" Scientific Research Funds Project of Chinese PLA)

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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