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Relaxation Response Training for the Treatment of Rheumatoid Arthritis - Article


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Arthritis

Psoriatic Arthritis 




Clinical Trial: Relaxation Response Training for the Treatment of Rheumatoid Arthritis

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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.

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Behavior: Relaxation Response Training
 Behavior: Cognitive Behavior Therapy
 Behavior: Rheumatoid Arthritis Education
Phase III

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Relaxation Response, Somatic Style and Rheumatoid Arthritis

Further Study Details: 

Expected Total Enrollment:  375

Study start: July 2001;  Expected completion: June 2006

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

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information

Josh Kingsbury      617-732-5969 
Jennifer Sy      617-732-5969 

Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Arthur J. Barsky, MD   abarsky@partners.org 
Arthur J. Barsky, MD,  Principal Investigator

Study chairs or principal investigators

Arthur J. Barsky, MD,  Principal Investigator,  Brigham & Women's Hospital, Boston, MA   

More Information

Study ID Numbers:  NIAMS-088; 1 R01 AR47014-01A1
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  March 20, 2003
ClinicalTrials.gov Identifier:  NCT00056667
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources

  • (National Women's Health Information Center, OWH, HHS)
  • 2004 Drug Guide (Arthritis Foundation)


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November 27, 2009



Page Updated: October 15, 2009
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