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Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00475111
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : May 17, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
Information provided by:
Arizona State University

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Cognitive Behavior Therapy for Pain (CBT-P) Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER) Behavioral: Rheumatoid arthritis education Not Applicable

Detailed Description:

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:

  • 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.
  • 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.
  • Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Stress and Adaptation in Rheumatoid Arthritis (SARA)
Study Start Date : March 2001
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
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.
Behavioral: Cognitive Behavior Therapy for Pain (CBT-P)
Experimental: 2
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.
Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER)
Experimental: 3
Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.
Behavioral: Rheumatoid arthritis education



Primary Outcome Measures :
  1. Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression [ Time Frame: 6 months after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA

Exclusion Criteria:

  • Currently taking cyclical estrogen replacement therapy
  • Diagnosis of lupus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475111


Locations
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United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287-1104
Sponsors and Collaborators
Arizona State University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
Investigators
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Principal Investigator: Alex J. Zautra, PhD Arizona State University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00475111    
Other Study ID Numbers: R01AR041687 ( U.S. NIH Grant/Contract )
R01AR041687 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Keywords provided by Arizona State University:
Cognitive Behavioral Intervention
Emotion Regulation
Pain Management
Psychological Adaptation
Coping Efficacy
Markers of Disease Activity
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases