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Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis Clinical research trials and Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis. Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis clinical trial. Subjects typically recieve the finest healthcare available for their Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis  Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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
Total Enrollment: 210
Location and Contact Information:
Overall Study Official:
PerryNicassio, Principal Investigator, University of California, Los Angeles
Cousins Center for Psychoneuroimmunology, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Perry Nicassio 310-825-3141
Additional Information:
Study ID Numbers: NIAMS-095; 1R01 AR49840-01
Study Start Date: February 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072657
Other Rheumatoid Arthritis Studies:
1. dnaJ Peptide for Relieving Rheumatoid Arthritis
2. Efficacy and Safety of Investigational Drug in Patients with Rheumatoid Arthritis Who Failed at Least One DMARD (Disease Modifying Anti-Rheumatic Drug)
3. A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis.
4. Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis
5. Antifolate Effectiveness in Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other California Clinical Trials
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Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
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