Relaxation Response Training for the Treatment of Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Relaxation response and cognitive behavioral therapy; Other: RA education; Behavioral: Relaxation response

• Registration Number: NCT00056667
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2003-03-20
• Study First Submitted QC: 2003-03-21
• Study First Posted: 2003-03-24
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT plus relaxation response	Relaxation response and cognitive behavioral therapy	Participants will receive cognitive behavioral therapy plus relaxation response training
Education	RA education	Participants will receive rheumatoid arthritis education
Relaxation Response	Relaxation response	Participants will receive relaxation response training

Primary Outcome Measures

Name	Time	Method
Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire	12 months

Secondary Outcome Measures

Name	Time	Method
Role impairment and functional status as assessed with the Functional Status Questionnaire	12 months
Medical care utilization as assessed with the hospital's automated encounter database	12 months

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States