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Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
This study has been completed.
Sponsors and Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00475111
  Purpose

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
Rheumatoid Arthritis
Behavioral: Cognitive Behavior Therapy for Pain (CBT-P)
Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER)
Behavioral: Rheumatoid arthritis education

MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Stress and Adaptation in Rheumatoid Arthritis (SARA)

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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

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
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.
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.
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.
Behavioral: Rheumatoid arthritis education

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA

Exclusion Criteria:

  • Currently taking cyclical estrogen replacement therapy
  • Diagnosis of lupus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475111

Locations
United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287-1104
Sponsors and Collaborators
Arthritis Foundation
Investigators
Principal Investigator: Alex J. Zautra, PhD Arizona State University
  More Information

Click here for the Stress and Adaptation in Rheumatoid Arthritis (SARA) study's intervention manuals  This link exits the ClinicalTrials.gov site

Publications:
Publications indexed to this study:
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

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Cognitive Behavioral Intervention
Emotion Regulation
Pain Management
Psychological Adaptation
Coping Efficacy
Markers of Disease Activity

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Stress
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009