Rheumatoid Arthritis Clinical Trial
Official title:
Relaxation Response, Somatic Style and Rheumatoid Arthritis
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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