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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Arthritis Foundation |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00475111 |
Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the joints and occasionally, other body tissues. The purpose of this study is to evaluate two different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and improving mental health of adults with RA.
Condition | Intervention |
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Rheumatoid Arthritis |
Behavioral: Cognitive Behavior Therapy for Pain (CBT-P) Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER) Behavioral: Rheumatoid arthritis education |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Stress and Adaptation in Rheumatoid Arthritis (SARA) |
Enrollment: | 136 |
Study Start Date: | March 2001 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
People in Group 1 will participate in CBT for Pain (CBT-P), which will focus on altering thought processes as a way to cope more effectively with pain.
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Behavioral: Cognitive Behavior Therapy for Pain (CBT-P) |
2: Experimental
People in Group 2 will participate in Mindfulness Medication for Emotion Regulation (MM-ER), a type of CBT that focuses on being more aware of one's emotions and regulating them.
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Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER) |
3: Experimental
Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.
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Behavioral: Rheumatoid arthritis education |
Symptoms of RA include swelling, pain, stiffness, and redness in the joints. Over time, joint deformity, joint destruction, and loss of function can occur. Even simple tasks of daily living can become difficult to manage for people with RA. Current treatment aims to improve symptoms, but there is currently no cure for the disease. Dealing with the long-term pain and the unpredictability of RA can cause symptoms of depression, which is common among people with RA, especially early in the disease. Improving coping skills and minimizing emotional stress may help improve the overall health of people with RA. CBT is a form of psychotherapy that emphasizes the important role of thinking in how we feel and what we do. This type of therapy emphasizes that people can change the way they think to feel or act better even if the situation does not change. The purpose of this study is to evaluate two different types of CBT that focus on stress, pain, and depression responses in reducing disease activity and improving mental health of adults with RA.
This study will last about 15 months. Initially, all participants will fill out a diary report about their symptoms for a total of 30 days. Half of the study participants will undergo a 2- to 3-hour lab session that will include blood collection, vital signs measurements, joint exams, questionnaires, and an interview about symptoms and medical history. All participants will then be randomly assigned to one of the following three groups:
Participants in all three groups will attend 2-hour weekly sessions of their treatment for 8 weeks. After treatment, all participants will undergo a 2- to 3-hour lab session that will include blood collection, vital signs measurements, joint exams, questionnaires, and an interview about symptoms and medical history. Participants will also fill out another daily diary report about their symptoms for 30 days. A follow-up questionnaire will be mailed to participants 6 months following the end of treatment.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona State University | |
Tempe, Arizona, United States, 85287-1104 |
Principal Investigator: | Alex J. Zautra, PhD | Arizona State University |
Study ID Numbers: | R01 AR041687 |
Study First Received: | May 16, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00475111 |
Health Authority: | United States: Federal Government |
Cognitive Behavioral Intervention Emotion Regulation Pain Management |
Psychological Adaptation Coping Efficacy Markers of Disease Activity |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis Connective Tissue Diseases |
Arthritis, Rheumatoid Stress Pain Rheumatic Diseases |
Immune System Diseases |