Clinical trial NCT00056667: Relaxation Response Training for the Treatment of Rheumatoid Arthritis
Official title: Relaxation Response, Somatic Style and Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Treatment
Pain
Relaxation Response
Cognitive Behavioral Therapy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2003-03-24
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Role impairment and functional status as assessed with the Functional Status Questionnaire
timeFrame: 12 months
measure: Medical care utilization as assessed with the hospital's automated encounter database
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham & Women's Hospital, Boston, MA
name: Arthur J. Barsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barsky AJ, Ahern DK, Orav EJ, Nestoriuc Y, Liang MH, Berman IT, Kingsbury JR, Sy JT, Wilk KG. A randomized trial of three psychosocial treatments for the symptoms of rheumatoid arthritis. Semin Arthritis Rheum. 2010 Dec;40(3):222-32. doi: 10.1016/j.semarthrit.2010.04.001.