- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072657
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
Behavioral Treatments for Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Cousins Center for Psychoneuroimmunology, UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will partake in cognitive behavioral therapy for 12 weeks.
|
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.
|
Experimental: 2
Participants will partake in tai chi chih for 12 weeks.
|
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.
|
Active Comparator: 3
Participants will act as a control and attend educational sessions for 12 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease activity
Time Frame: Measured at Week 12 and Months 4 and 8 follow-up
|
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
|
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
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mood disturbances
Time Frame: Measured at Week 12 and Months 4 and 8 follow-up
|
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
|
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
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Perry M. Nicassio, PhD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AR049840 (U.S. NIH Grant/Contract)
- NIAMS-095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States