Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

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.
    

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.
    

Intervention name(s): Cognitive Behavior Therapy for Pain (CBT-P); Mindfulness Meditation for Emotion Regulation (MM-ER); Rheumatoid arthritis education
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cognitive Behavioral Intervention; Emotion Regulation; Pain Management; Psychological Adaptation; Coping Efficacy; Markers of Disease Activity