Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 AR47014


NCT ID:

NCT00056667


Secondary ID:

R01AR047014


Study Acronym:


Brief Title:

Relaxation Response Training for the Treatment of Rheumatoid Arthritis


Official Title:

Relaxation Response, Somatic Style and Rheumatoid Arthritis


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

168


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:July 2001
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 15, 2014
First Received Date:March 20, 2003

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Medical care utilization as assessed with the hospital's automated encounter database
Time Frame:12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Role impairment and functional status as assessed with the Functional Status Questionnaire
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire
Time Frame:12 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Relaxation response and cognitive behavioral thera
Description: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 progra
Arm Name:CBT plus relaxation response
Other Name:RRCBT
Intervention Type:Behavioral
Name:Relaxation response
Description: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 rel
Arm Name:Relaxation Response
Other Name:RR
Intervention Type:Other
Name:RA education
Description: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 randomi
Arm Name:Education
Other Name:RA Education

Study Arms

Study Arm Type:Experimental
Arm Name:CBT plus relaxation response
Description:Participants will receive cognitive behavioral therapy plus relaxation response training
Study Arm Type:Active Comparator
Arm Name:Relaxation Response
Description:Participants will receive relaxation response training
Study Arm Type:Placebo Comparator
Arm Name:Education
Description:Participants will receive rheumatoid arthritis education

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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