Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Perry Nicassio, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00072657
First received: November 7, 2003
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Behavioral: Cognitive Behavioral Therapy
Behavioral: Tai Chi Chih
Behavioral: Health Education Seminar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Treatments for Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Disease activity [ Time Frame: Measured at Week 12 and Months 4 and 8 follow-up ] [ Designated as safety issue: No ]
  • Health functioning [ Time Frame: Measured at Week 12 and Months 4 and 8 follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood disturbances [ Time Frame: Measured at Week 12 and Months 4 and 8 follow-up ] [ Designated as safety issue: No ]
  • Coping [ Time Frame: Measured at Week 12 and Months 4 and 8 follow-up ] [ Designated as safety issue: No ]
  • Helplessness [ Time Frame: Measured at Week 12 and Months 4 and 8 follow-up ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: February 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will partake in cognitive behavioral therapy for 12 weeks.
Behavioral: Cognitive Behavioral Therapy
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.
Behavioral: Tai Chi Chih
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.
Behavioral: Health Education Seminar
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072657

Locations
United States, California
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Perry M. Nicassio, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Perry Nicassio, Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00072657     History of Changes
Other Study ID Numbers: R01 AR49840, R01AR049840, NIAMS-095
Study First Received: November 7, 2003
Last Updated: April 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Arthritis
Pain
Meditation
Tai Chi
Chronic Illness
Depression

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014