Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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


NCT ID:

NCT00056667


Primary Contact:

Principal Investigator
Arthur J. Barsky, MD
Brigham & Women's Hospital, Boston, MA


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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