Rheumatoid ArthritisNCT00475111
Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)
A study testing Cognitive Behavior Therapy for Pain (CBT-P), Mindfulness Meditation for Emotion Regulation (MM-ER) and Rheumatoid arthritis education in people with Rheumatoid Arthritis, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cognitive Behavior Therapy for Pain (CBT-P), Mindfulness Meditation for Emotion Regulation (MM-ER) and Rheumatoid arthritis education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA
Who cannot join
- Currently taking cyclical estrogen replacement therapy
- Diagnosis of lupus
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cognitive Behavior Therapy for Pain (CBT-P), Mindfulness Meditation for Emotion Regulation (MM-ER), Rheumatoid arthritis education
- Keywords
- Cognitive Behavioral Intervention, Emotion Regulation, Pain Management, Psychological Adaptation, Coping Efficacy, Markers of Disease Activity
- Medical subject headings
- Arthritis, Rheumatoid, Emotional Regulation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for Pain (CBT-P)Behavioural
Mindfulness Meditation for Emotion Regulation (MM-ER)Behavioural
Rheumatoid arthritis educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Rheumatoid arthritis education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMar 2001
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation
- Investigators
- Alex J. Zautra, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475111
- Sponsor's protocol ID
- R01AR041687
- Other IDs
- R01AR041687
- Status last verified
- May 2013
- First submitted
- 16 May 2007
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16904829Davis 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.
PubMed 16810668Zautra 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.
PubMed 16274444Zautra 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.
PubMed 17055648Davis 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.
PubMed 25365778Zautra 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.
PubMed 18540734
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Adaptation in Rheumatoid Arthritis (SARA)
- ClinicalTrials.gov ID
- NCT00475111
- Acronym / sponsor ID
- R01AR041687
- Conditions
- Rheumatoid Arthritis
- Keywords
- Cognitive Behavioral Intervention, Emotion Regulation, Pain Management, Psychological Adaptation, Coping Efficacy, Markers of Disease Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation
- Study start
- Mar 2001
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavior Therapy for Pain (CBT-P)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. |
| 2 | Experimental | Behavioral: Mindfulness Meditation for Emotion Regulation (MM-ER)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. |
| 3 | Experimental | Behavioral: Rheumatoid arthritis educationGroup 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of RA
Key exclusion criteria (2 listed)
- Currently taking cyclical estrogen replacement therapy
- Diagnosis of lupus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy for Pain (CBT-P) | Behavioural | 1 |
| Mindfulness Meditation for Emotion Regulation (MM-ER) | Behavioural | 2 |
| Rheumatoid arthritis education | Behavioural | 3 |
Primary outcome
Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Background: PubMed 16904829Conner 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.
- Background: PubMed 16810668Davis 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.
- Background: PubMed 16274444Zautra 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.
- Background: PubMed 17055648Zautra 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.
- Derived from this study: PubMed 25365778Davis 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.
- Derived from this study: PubMed 18540734Zautra 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.
- Click here for the Stress and Adaptation in Rheumatoid Arthritis (SARA) study's intervention manualsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex J. Zautra, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Pain (CBT-P), Mindfulness Meditation for Emotion Regulation (MM-ER) and Rheumatoid arthritis education in people with Rheumatoid Arthritis, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475111, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.