Coping Skills Training for Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00056394
First received: March 11, 2003
Last updated: July 11, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Behavioral: Comprehensive Coping Skills Training
Behavioral: Arthritis Education Sessions
Behavioral: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Coping Skills Training for Early Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pain [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • Psychological disability [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • Physical disability [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erythrocyte sedimentation rate [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • Joint tenderness count [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • Physician assessment of disease activity [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: February 2003
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive comprehensive pain coping skills.
Behavioral: Comprehensive Coping Skills Training
10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
Active Comparator: 2
Participants will receive arthritis education.
Behavioral: Arthritis Education Sessions
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.
Active Comparator: 3
Participants will receive standard care.
Behavioral: Standard Care
Usual care from participants' rheumatologists but no treatment sessions.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056394

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J. Keefe, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00056394     History of Changes
Other Study ID Numbers: Pro00007830, R01AR047218, NIAMS-086
Study First Received: March 11, 2003
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Early Rheumatoid Arthritis
Coping Skills Training
Pain
Physical Disability
Psychological Disability
Daily Diary Measures

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 02, 2014