Rheumatoid ArthritisNCT00072657
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
A study testing Cognitive Behavioral Therapy, Tai Chi Chih and Health Education Seminar in people with Rheumatoid Arthritis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Rheumatoid arthritis (RA) is a chronic illness. Patients with RA often experience significant pain and depression. This study will evaluate two programs designed to improve the symptoms of RA: cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC), compared to a health education seminar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cognitive Behavioral Therapy, Tai Chi Chih and Health Education Seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA as defined by the American College of Rheumatology (ACR) and consistent with revised criteria for RA
- Stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
- Relatively stable disease course for 3 months prior to study entry
- If treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
- If taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
- Resides in Greater Los Angeles area
Who cannot join
- Inactive RA conditions defined as "in remission"
- Experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
- Serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
- Use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for RA treatment, tramadol (Ultram) or Tylenol with codeine on an as-needed basis, or propoxyphen (Darvocet, Wygesic)
- Use of oxycodone (Percocet), hydrocodone (Vicodin), morphine, or hydromorphone (Dilaudid)
- Use of high levels of methotrexate (greater than 7.5 mg)
Show all 11Show fewer
- Use of nitrogen mustard, cyclosporine, monoclonal antibodies, or cyclophosphamide within the 6 months prior to study entry
- Serious psychiatric conditions, such as bipolar disorder, psychotic disorders, or organic brain syndromes
- At risk for suicide
- Dependent on canes, walkers, or other assistive devices
- Unable to commit to study schedule/itinerary or unwilling to be assigned to any of the 3 treatment groups
Trial locations and contacts
1 site in 1 country.
United States1 site
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, 90095
About this study
Official title: Behavioral Treatments for Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic illness. Patients with RA often experience significant pain and depression. This study will evaluate two programs designed to improve the symptoms of RA: cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC), compared to a health education seminar.
Read the detailed description
Rheumatoid arthritis is a progressive inflammatory illness marked by severe functional declines, significant economic and social costs, and significant psychological distress. Environmental and psychosocial factors such as stress, mood disturbance, and coping mechanisms may contribute to changes in important health outcomes, including disability and disease activity in RA. This study will compare CBT with TCC, a relaxation-based intervention, combining elements of slow gentle movement with meditation, against a more traditional health education seminar. Outcome measures will include psychological adaptation, mood disturbance, sleep quality, physiological adaptation, and disease severity.
Two hundred-ten patients will be randomly assigned to either CBT, TCC, or a control group. The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each. Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50 to 60 minute biweekly sessions during the 12-week study. Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
Participants will be assessed prior to beginning treatment, at mid-treatment (Week 6) and again at the end of treatment (Week 12 to 13). The long term effect of interventions will be assessed at follow-up interviews 4 months and 8 months after the end of formal treatment. Psychosocial adaptation, mood disturbance and sleep quality, self-reported pain, and immune function will be measured at all five assessment periods.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cognitive Behavioral Therapy, Tai Chi Chih, Health Education Seminar
- Keywords
- Arthritis, Pain, Meditation, Tai Chi, Chronic Illness, Depression
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Pain, Chronic Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each.
Tai Chi ChihBehavioural
Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50- to 60-minute biweekly sessions during the 12-week study.
Health Education SeminarBehavioural
Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will partake in cognitive behavioral therapy for 12 weeks. Receives: Behavioral: Cognitive Behavioral Therapy |
| 2 | Experimental | Participants will partake in tai chi chih for 12 weeks. Receives: Behavioral: Tai Chi Chih |
| 3 | Active comparator | Participants will act as a control and attend educational sessions for 12 weeks. Receives: Behavioral: Health Education Seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Health functioning
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Secondary outcomes (3)
Mood disturbances
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Coping
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Helplessness
Measured: Measured at Week 12 and Months 4 and 8 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2003 (estimated)
- Study startFeb 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of California, Los AngelesThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Perry Nicassio, University of California, Los Angeles
- Investigators
- Perry M. Nicassio, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072657
- Sponsor's protocol ID
- R01AR049840
- Other IDs
- R01AR049840, NIAMS-095
- Status last verified
- Apr 2013
- First submitted
- 7 Nov 2003
- Last updated
- 4 Apr 2013
- Results posted
- No
Publications
Azizoddin DR, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic status, reserve capacity, and depressive symptoms predict pain in Rheumatoid Arthritis: an examination of the reserve capacity model. BMC Rheumatol. 2024 Sep 20;8(1):46. doi: 10.1186/s41927-024-00416-4.
PubMed 39304956Azizoddin D, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic Status, Reserve Capacity, and Depressive Symptoms Predict Pain in Rheumatoid Arthritis: An Examination of the Reserve Capacity Model. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2758092. doi: 10.21203/rs.3.rs-2758092/v1.
PubMed 37066198Ormseth SR, Draper TL, Irwin MR, Weisman MH, Arechiga AE, Hartoonian N, Bui T, Nicassio PM. Multidimensional Model of Disability and Role Functioning in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1686-92. doi: 10.1002/acr.22658.
PubMed 26212464
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatments for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00072657
- Acronym / sponsor ID
- R01AR049840
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, Pain, Meditation, Tai Chi, Chronic Illness, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Nov 2003 (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 a chronic illness. Patients with RA often experience significant pain and depression. This study will evaluate two programs designed to improve the symptoms of RA: cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC), compared to a health education seminar.
Detailed description
Rheumatoid arthritis is a progressive inflammatory illness marked by severe functional declines, significant economic and social costs, and significant psychological distress. Environmental and psychosocial factors such as stress, mood disturbance, and coping mechanisms may contribute to changes in important health outcomes, including disability and disease activity in RA. This study will compare CBT with TCC, a relaxation-based intervention, combining elements of slow gentle movement with meditation, against a more traditional health education seminar. Outcome measures will include psychological adaptation, mood disturbance, sleep quality, physiological adaptation, and disease severity.
Two hundred-ten patients will be randomly assigned to either CBT, TCC, or a control group. The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each. Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50 to 60 minute biweekly sessions during the 12-week study. Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
Participants will be assessed prior to beginning treatment, at mid-treatment (Week 6) and again at the end of treatment (Week 12 to 13). The long term effect of interventions will be assessed at follow-up interviews 4 months and 8 months after the end of formal treatment. Psychosocial adaptation, mood disturbance and sleep quality, self-reported pain, and immune function will be measured at all five assessment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants will partake in cognitive behavioral therapy for 12 weeks. |
| 2 | Experimental | Behavioral: Tai Chi ChihParticipants will partake in tai chi chih for 12 weeks. |
| 3 | Active comparator | Behavioral: Health Education SeminarParticipants will act as a control and attend educational sessions for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of RA as defined by the American College of Rheumatology (ACR) and consistent with revised criteria for RA
- Stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
- Relatively stable disease course for 3 months prior to study entry
- If treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
- If taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
Key exclusion criteria (11 listed)
- Inactive RA conditions defined as "in remission"
- Experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
- Serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
- Use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for RA treatment, tramadol (Ultram) or Tylenol with codeine on an as-needed basis, or propoxyphen (Darvocet, Wygesic)
- Use of oxycodone (Percocet), hydrocodone (Vicodin), morphine, or hydromorphone (Dilaudid)
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 Behavioral TherapyThe CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each. | Behavioural | 1 |
| Tai Chi ChihParticipants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50- to 60-minute biweekly sessions during the 12-week study. | Behavioural | 2 |
| Health Education SeminarControl group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine. | Behavioural | 3 |
Primary outcome
Disease activity
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
Health functioning
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
3 secondary outcomes
Mood disturbances
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
Coping
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
Helplessness
Time frame: Measured at Week 12 and Months 4 and 8 follow-up
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 4 Apr 2013.
- Derived from this study: PubMed 39304956Azizoddin DR, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic status, reserve capacity, and depressive symptoms predict pain in Rheumatoid Arthritis: an examination of the reserve capacity model. BMC Rheumatol. 2024 Sep 20;8(1):46. doi: 10.1186/s41927-024-00416-4.
- Derived from this study: PubMed 37066198Azizoddin D, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic Status, Reserve Capacity, and Depressive Symptoms Predict Pain in Rheumatoid Arthritis: An Examination of the Reserve Capacity Model. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2758092. doi: 10.21203/rs.3.rs-2758092/v1.
- Derived from this study: PubMed 26212464Ormseth SR, Draper TL, Irwin MR, Weisman MH, Arechiga AE, Hartoonian N, Bui T, Nicassio PM. Multidimensional Model of Disability and Role Functioning in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1686-92. doi: 10.1002/acr.22658.
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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.
Perry M. Nicassio, PhD principal investigator
University of California, Los Angeles
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 Behavioral Therapy, Tai Chi Chih and Health Education Seminar in people with Rheumatoid Arthritis, run by University of California, Los Angeles 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 6 inclusion and 11 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 4 Apr 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?
Disease activity (time frame: Measured at Week 12 and Months 4 and 8 follow-up). The study lists 3 primary outcomes in all. 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 NCT00072657, which also lists 3 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 4 Apr 2013.