Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)

NCT00475111 | Completed

• 1 other identifier: R01AR041687
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Cognitive Behavioral Intervention; Emotion Regulation; Pain Management; Psychological Adaptation; Coping Efficacy; Markers of Disease Activity

Outcome Measures

Primary Outcomes (1)

• Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression

  6 months after treatment

Study Arms (3)

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

Interventions

Cognitive Behavior Therapy for Pain (CBT-P) BEHAVIORAL

1

Mindfulness Meditation for Emotion Regulation (MM-ER) BEHAVIORAL

2

Rheumatoid arthritis education BEHAVIORAL

3

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RA

You may not qualify if:

• Currently taking cyclical estrogen replacement therapy
• Diagnosis of lupus

Sponsors & Collaborators

• Arizona State University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Arthritis Foundation: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287-1104, United States

Location

Related Publications (6)

• 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.

  PMID: 16904829 BACKGROUND

• 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.

  PMID: 16810668 BACKGROUND

• 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.

  PMID: 16274444 BACKGROUND

• 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.

  PMID: 17055648 BACKGROUND

• 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.

  PMID: 25365778 DERIVED

• 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.

  PMID: 18540734 DERIVED

Related Links

• Click here for the Stress and Adaptation in Rheumatoid Arthritis (SARA) study's intervention manuals

MeSH Terms

Conditions

Arthritis, Rheumatoid; Emotional Regulation; Agnosia

Interventions

Cognitive Behavioral Therapy; Mindfulness

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Self-Control; Social Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alex J. Zautra, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: March 1, 2001
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

US (1)