Rheumatoid Arthritis Clinical Trial
Official title:
Stress and Adaptation in Rheumatoid Arthritis (SARA)
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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