Arthritis |
Psoriatic Arthritis |
Clinical Trial: Relaxation Response Training for the Treatment of Rheumatoid Arthritis
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Behavior: Relaxation Response Training Behavior: Cognitive Behavior Therapy Behavior: Rheumatoid Arthritis Education | Phase III |
MedlinePlus related topics: Rheumatoid Arthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Relaxation Response, Somatic Style and Rheumatoid Arthritis
Expected Total Enrollment: 375
Study start: July 2001; Expected completion: June 2006
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.
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria
- RA as defined by the American College of Rheumatology
- English literacy and fluency
Exclusion criteria
- Major medical condition or illness which limits life expectancy or results in severe symptoms or functional disability (Duke Severity of Illness score > 0.85)
- Fibromyalgia
- Received or currently receiving psychosocial treatment for RA
- Unavailability for Month 12 follow-up
Location and Contact Information
Jennifer Sy 617-732-5969
Massachusetts
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Arthur J. Barsky, MD, Principal Investigator
Arthur J. Barsky, MD, Principal Investigator, Brigham & Women's Hospital, Boston, MA
More Information
Record last reviewed: March 2005
Last Updated: March 2, 2005
Record first received: March 20, 2003
ClinicalTrials.gov Identifier: NCT00056667
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- 2004 Drug Guide (Arthritis Foundation)

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