Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056394
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2003-03-11
Brief Title:
Coping Skills Training for Early Rheumatoid Arthritis
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Coping Skills Training for Early Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-086 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR047218 |
| R01AR047218 | NIH | None | None |