Relaxation Response Training for the Treatment of Rheumatoid Arthritis

PHASE4CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2006

Conditions
Rheumatoid Arthritis
Interventions
BEHAVIORAL

Relaxation response and cognitive behavioral therapy

The cognitive behavioral therapy program wwill incorporate relaxation training, a modified version of the RA treatment program developed by Bradley et al (1987) and shown to be effective. The cognitive behavioral techniques include problem solving, relabeling, enhanced awareness of pain behaviors, and attention refocusing. The RR component includes instruction in diaphragmatic breathing along with progressive skeletal muscle relaxation. The intervention will be modified from the original program in that neither biofeedback training nor participation of family members will be included. Consequently, the number of weekly group sessions will be reduced from 14 to 12. Homework will be given at the end of each session, to be completed and brought in for review to the next session.

BEHAVIORAL

Relaxation response

The relaxation response (RR) consists of a set of integrated physiological changes elicited when a participant engages in the repetitive mental action of focusing on a word, phrase, or image, while passively ignoring distracting thoughts. These changes include decreased oxygen consumption, heart rate, arterial blood pressure, respiratory rate, and arterial blood lactate, along with slight increases in skeletal muscle blood flow. The long-term physiologic changes of participants eliciting the relaxation response are consistent with reduced norepinephrine end organ responsivity. These latter changes provide a plausible psychophysiological mechanism for longer-term actions of the RR.

OTHER

RA education

RA education programs have been widely used to supplement routine medical care. They have been found to be of modest benefit, particularly in terms of knowledge about the condition and its treatment. The long-term effects on pain and level of function are less. When used as an attention control, such educational programs have been found to be as credible and as well attended as the active experimental treatment (Professor Francis Keefe, Personal Communication). In this study, patients randomized to the control condition will receive 8 weekly sessions of RA education, in groups of 6-10 patients each, using portions of the Arthritis Self-Management Program and incorporating printed and videotaped materials available from the Arthritis Foundation.

Trial Locations (1)

02115

Brigham & Women's Hospital, Boston

All Listed Sponsors
collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

lead

Brigham and Women's Hospital

OTHER

NCT00056667 - Relaxation Response Training for the Treatment of Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter