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Coping Skills Training for Early Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Coping Skills Training
Arthritis Education Sessions
Standard Care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis, Coping Skills Training, Pain, Physical Disability, Psychological Disability, Daily Diary Measures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Meet at least 4 of the 7 criteria for RA classification based on the 1987 American College of Rheumatology criteria Onset of RA symptoms within 2 years of study entry Exclusion Criteria Known organic disease that significantly affects function Rheumatic disorders in addition to RA that significantly affect function

Sites / Locations

  • Duke University
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive comprehensive pain coping skills.

Participants will receive arthritis education.

Participants will receive standard care.

Outcomes

Primary Outcome Measures

Pain
Psychological disability
Physical disability

Secondary Outcome Measures

Erythrocyte sedimentation rate
Joint tenderness count
Grip strength
Physician assessment of disease activity
C reactive protein

Full Information

First Posted
March 11, 2003
Last Updated
October 24, 2018
Sponsor
Duke University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00056394
Brief Title
Coping Skills Training for Early Rheumatoid Arthritis
Official Title
Coping Skills Training for Early Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. Medical treatments are now being used much earlier in the course of RA, but these treatments do not address the challenges of coping with the early stages of this disease. This study will determine whether a comprehensive coping skills training program can decrease pain, psychological disability, and physical disability in patients with early RA.
Detailed Description
RA is a serious and complex disease that taxes patients' coping resources. Patients with RA must cope with pain and with major life stresses, including disruptions in their health, work, family, and marital functioning. Recognition of the morbidity and mortality associated with RA has increased interest in early interventions. Rapid disease progression during the first few years of RA taxes patients' coping efforts. Those who cope well with the early stages of RA can maintain an active and rewarding lifestyle. Those who do not may become depressed, decrease physical activity, and develop a sedentary, restricted lifestyle that contributes to long-term disability and overdependence on family and friends. This study will evaluate the effectiveness of early coping skills training (CST) to enhance self-efficacy, prepare patients to cope with future pain, and prevent the development of behaviors that may increase long-term psychological distress and physical disability. The comprehensive CST intervention combines traditional CST with CST components tailored to rheumatoid arthritis patients. It is designed to teach traditional coping skills such as attention diversion, cognitive restructuring, and changes in activity to control and decrease pain. Participants will be randomized to one of three study groups: 1) comprehensive pain coping skills training; 2) arthritis education; or 3) standard care. Study participants assigned to the comprehensive CST and the arthritis education groups will be asked to attend ten weekly, 80-minute treatment sessions. These ten sessions will be followed by a series of six biweekly follow-up telephone calls. Study participants in the arthritis education group will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection. Study participants in the standard care group will continue to receive care from their rheumatologists but will not participate in any treatment sessions. Measures of pain, disability, pain coping, and self efficacy will be collected during evaluation sessions before and after the treatment phase. Participants attend 5 evaluation sessions and will be followed for 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis, Coping Skills Training, Pain, Physical Disability, Psychological Disability, Daily Diary Measures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive comprehensive pain coping skills.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive arthritis education.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Coping Skills Training
Intervention Description
10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
Intervention Type
Behavioral
Intervention Name(s)
Arthritis Education Sessions
Intervention Description
10 weekly, 80-minute treatment sessions, followed by a series of six biweekly follow-up telephone calls. Participants will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Usual care from participants' rheumatologists but no treatment sessions.
Primary Outcome Measure Information:
Title
Pain
Time Frame
Measured at Week 10
Title
Psychological disability
Time Frame
Measured at Week 10
Title
Physical disability
Time Frame
Measured at Week 10
Secondary Outcome Measure Information:
Title
Erythrocyte sedimentation rate
Time Frame
Measured at Week 10
Title
Joint tenderness count
Time Frame
Measured at Week 10
Title
Grip strength
Time Frame
Measured at Week 10
Title
Physician assessment of disease activity
Time Frame
Measured at Week 10
Title
C reactive protein
Time Frame
Measured at Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Meet at least 4 of the 7 criteria for RA classification based on the 1987 American College of Rheumatology criteria Onset of RA symptoms within 2 years of study entry Exclusion Criteria Known organic disease that significantly affects function Rheumatic disorders in addition to RA that significantly affect function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis J. Keefe, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Coping Skills Training for Early Rheumatoid Arthritis

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