Relaxation Response Training for the Treatment of Rheumatoid Arthritis

NCT ID: NCT00056667

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2006-12-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT plus relaxation response

Participants will receive cognitive behavioral therapy plus relaxation response training

Group Type: EXPERIMENTAL

Relaxation response and cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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.

Relaxation Response

Participants will receive relaxation response training

Group Type: ACTIVE_COMPARATOR

Relaxation response

Intervention Type: BEHAVIORAL

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.

Education

Participants will receive rheumatoid arthritis education

Group Type: PLACEBO_COMPARATOR

RA education

Intervention Type: OTHER

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.

Interventions

Relaxation response and cognitive behavioral therapy

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.

Intervention Type: BEHAVIORAL

Relaxation response

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.

Intervention Type: BEHAVIORAL

RA education

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.

Intervention Type: OTHER

Other Intervention Names

RRCBT; RR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arthur Joseph Barsky III,M.D.

Vice Chair for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur J. Barsky, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham & Women's Hospital, Boston, MA

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20621334 (View on PubMed)

Other Identifiers

R01AR047014

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-088

Identifier Type: -

Identifier Source: secondary_id

R01AR047014

Identifier Type: NIH

Identifier Source: org_study_id

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