Relaxation Response Training for the Treatment of Rheumatoid Arthritis
Relaxation Response, Somatic Style and Rheumatoid Arthritis
2 other identifiers
interventional
168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Jul 2001
Longer than P75 for phase_4 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 20, 2003
CompletedFirst Posted
Study publicly available on registry
March 24, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 17, 2014
January 1, 2014
5.4 years
March 20, 2003
January 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire
12 months
Secondary Outcomes (2)
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
Study Arms (3)
CBT plus relaxation response
EXPERIMENTALParticipants will receive cognitive behavioral therapy plus relaxation response training
Relaxation Response
ACTIVE COMPARATORParticipants will receive relaxation response training
Education
PLACEBO COMPARATORParticipants will receive rheumatoid arthritis education
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- RA as defined by the American College of Rheumatology
- English literacy and fluency
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 20621334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur J. Barsky, MD
Brigham & Women's Hospital, Boston, MA
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair for Research
Study Record Dates
First Submitted
March 20, 2003
First Posted
March 24, 2003
Study Start
July 1, 2001
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 17, 2014
Record last verified: 2014-01