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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy for Pain (CBT-P)
Mindfulness Meditation for Emotion Regulation (MM-ER)
Rheumatoid arthritis education
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Cognitive Behavioral Intervention, Emotion Regulation, Pain Management, Psychological Adaptation, Coping Efficacy, Markers of Disease Activity

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of RA

Exclusion Criteria:

  • Currently taking cyclical estrogen replacement therapy
  • Diagnosis of lupus

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2007
Last Updated
May 16, 2013
Sponsor
Arizona State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00475111
Brief Title
Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
Official Title
Stress and Adaptation in Rheumatoid Arthritis (SARA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arizona State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Cognitive Behavioral Intervention, Emotion Regulation, Pain Management, Psychological Adaptation, Coping Efficacy, Markers of Disease Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy for Pain (CBT-P)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation for Emotion Regulation (MM-ER)
Intervention Type
Behavioral
Intervention Name(s)
Rheumatoid arthritis education
Primary Outcome Measure Information:
Title
Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA Exclusion Criteria: Currently taking cyclical estrogen replacement therapy Diagnosis of lupus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex J. Zautra, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287-1104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16904829
Citation
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.
Results Reference
background
PubMed Identifier
16810668
Citation
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.
Results Reference
background
PubMed Identifier
16274444
Citation
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.
Results Reference
background
PubMed Identifier
17055648
Citation
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.
Results Reference
background
PubMed Identifier
25365778
Citation
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.
Results Reference
derived
PubMed Identifier
18540734
Citation
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.
Results Reference
derived

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

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