- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475111
Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
Stress and Adaptation in Rheumatoid Arthritis (SARA)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tempe, Arizona, United States, 85287-1104
- Arizona State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of RA
Exclusion Criteria:
- Currently taking cyclical estrogen replacement therapy
- Diagnosis of lupus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
|
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.
|
|
EXPERIMENTAL: 3
Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression
Time Frame: 6 months after treatment
|
6 months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alex J. Zautra, PhD, Arizona State University
Publications and helpful links
General Publications
- Conner TS, Tennen H, Zautra AJ, Affleck G, Armeli S, Fifield J. Coping with rheumatoid arthritis pain in daily life: within-person analyses reveal hidden vulnerability for the formerly depressed. Pain. 2006 Dec 15;126(1-3):198-209. doi: 10.1016/j.pain.2006.06.033. Epub 2006 Aug 14.
- Davis MC, Affleck G, Zautra AJ, Tennen H. Daily interpersonal events in pain patients: applying action theory to chronic illness. J Clin Psychol. 2006 Sep;62(9):1097-113. doi: 10.1002/jclp.20297.
- Zautra AJ, Affleck GG, Tennen H, Reich JW, Davis MC. Dynamic approaches to emotions and stress in everyday life: Bolger and Zuckerman reloaded with positive as well as negative affects. J Pers. 2005 Dec;73(6):1511-38. doi: 10.1111/j.0022-3506.2005.00357.x.
- Zautra AJ, Fasman R, Parish BP, Davis MC. Daily fatigue in women with osteoarthritis, rheumatoid arthritis, and fibromyalgia. Pain. 2007 Mar;128(1-2):128-35. doi: 10.1016/j.pain.2006.09.004. Epub 2006 Oct 20.
- Davis MC, Zautra AJ, Wolf LD, Tennen H, Yeung EW. Mindfulness and cognitive-behavioral interventions for chronic pain: differential effects on daily pain reactivity and stress reactivity. J Consult Clin Psychol. 2015 Feb;83(1):24-35. doi: 10.1037/a0038200. Epub 2014 Nov 3.
- Zautra AJ, Davis MC, Reich JW, Nicassario P, Tennen H, Finan P, Kratz A, Parrish B, Irwin MR. Comparison of cognitive behavioral and mindfulness meditation interventions on adaptation to rheumatoid arthritis for patients with and without history of recurrent depression. J Consult Clin Psychol. 2008 Jun;76(3):408-421. doi: 10.1037/0022-006X.76.3.408.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AR041687 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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