Relaxation Response Training for the Treatment of Rheumatoid Arthritis

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Relaxation response; Other: RA education; Behavioral: Relaxation response and cognitive behavioral therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00056667

R01AR047014 (U.S. NIH Grant/Contract)

NIAMS-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 3 patient groups, including a placebo group

CBT plus relaxation response

Experimental group

Description:

Participants will receive cognitive behavioral therapy plus relaxation response training

Treatment:

Behavioral: Relaxation response and cognitive behavioral therapy

Relaxation Response

Active Comparator group

Description:

Participants will receive relaxation response training

Treatment:

Behavioral: Relaxation response

Education

Placebo Comparator group

Description:

Participants will receive rheumatoid arthritis education

Treatment:

Other: RA education