Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
NCT ID: NCT00475111
Last Updated: 2013-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
136 participants
INTERVENTIONAL
2001-03-31
2006-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Meditation-Based Stress Reduction in Rheumatoid Arthritis
NCT00071292
Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
NCT06276387
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
NCT00072657
Meditation Effects on Brain Function in Rheumatoid Arthritis
NCT03975595
Relaxation Response Training for the Treatment of Rheumatoid Arthritis
NCT00056667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Cognitive Behavior Therapy for Pain (CBT-P)
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.
Mindfulness Meditation for Emotion Regulation (MM-ER)
3
Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.
Rheumatoid arthritis education
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Behavior Therapy for Pain (CBT-P)
Mindfulness Meditation for Emotion Regulation (MM-ER)
Rheumatoid arthritis education
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Diagnosis of lupus
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Arthritis Foundation
OTHER
Arizona State University
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alex J. Zautra, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona State University
Tempe, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for the Stress and Adaptation in Rheumatoid Arthritis (SARA) study's intervention manuals
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.