Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056667
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2003-03-20
Brief Title:
Relaxation Response Training for the Treatment of Rheumatoid Arthritis
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Relaxation Response Somatic Style and Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This study will evaluate the relative effectiveness of Relaxation Response RR training for the treatment of rheumatoid arthritis RA The study will compare RR training to RR training with cognitive behavioral therapy and to a standard RA education program
Detailed Description:
RR training is a part of most multi-component psychosocial therapies for RA RR training may decrease perceived psychosocial stress and autonomic tone which in turn diminishes pain and the anticipatory anxiety associated with pain RR training involves learning relaxation techniques which include diaphragmatic breathing progressive skeletal muscle relaxation and the induction of a state of focused attention on a chosen word phrase or image
In clinical practice RR training is generally administered as one component of RA therapy In this study the effectiveness of RR training will be evaluated when RR training is administered alone and in combination with a cognitive behavioral therapy program The cognitive behavior techniques include problem solving relabeling enhanced awareness of pain behaviors and attention refocusing The effectiveness of RR training will be evaluated in comparison to standard RA education that includes topics such as the nature of RA disease medical therapies physical activities nutrition and pain mechanisms
After a baseline assessment of health beliefs RA severity social support and psychological distress patients will be randomized to one of three study arms Patients in Arm A will complete six individualized weekly RR training sessions Patients will receive a 20-minute audiotape to guide them through the exercise they are asked to practice 5 to 7 times per week Patients in Arm B will learn cognitive behavioral and RR techniques during eight weekly sessions Patients in Arm C will receive standard RA education After the initial training all patients will be followed up with monthly telephone conversations for 4 months Patients will have follow-up study visits at Months 6 and 12 Follow-up study visits include a medical interview physical exam and blood tests
In clinical practice RR training is generally administered as one component of RA therapy In this study the effectiveness of RR training will be evaluated when RR training is administered alone and in combination with a cognitive behavioral therapy program The cognitive behavior techniques include problem solving relabeling enhanced awareness of pain behaviors and attention refocusing The effectiveness of RR training will be evaluated in comparison to standard RA education that includes topics such as the nature of RA disease medical therapies physical activities nutrition and pain mechanisms
After a baseline assessment of health beliefs RA severity social support and psychological distress patients will be randomized to one of three study arms Patients in Arm A will complete six individualized weekly RR training sessions Patients will receive a 20-minute audiotape to guide them through the exercise they are asked to practice 5 to 7 times per week Patients in Arm B will learn cognitive behavioral and RR techniques during eight weekly sessions Patients in Arm C will receive standard RA education After the initial training all patients will be followed up with monthly telephone conversations for 4 months Patients will have follow-up study visits at Months 6 and 12 Follow-up study visits include a medical interview physical exam and blood tests
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 |
|---|---|---|---|
| R01AR047014 | NIH | None | None |
| NIAMS-088 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR047014 |