Back to resultsCognitive-behavioral Treatment for Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive-behavioral treatment
Waiting List
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- General Hospital of Chengdu Military Area Command PLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CBT
WLT
Arm Description
Cognitive-behavioral treatment
Waiting in list
Outcomes
Primary Outcome Measures
Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02257073
First Posted
October 2, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02257073
Brief Title
Cognitive-behavioral Treatment for Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive-behavioral treatment
Arm Title
WLT
Arm Type
Sham Comparator
Arm Description
Waiting in list
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral treatment
Intervention Type
Behavioral
Intervention Name(s)
Waiting List
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
12. IPD Sharing Statement
Learn more about this trial
Cognitive-behavioral Treatment for Rheumatoid Arthritis
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