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Completed

NCT Number: NCT00072657

Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 Chih

Behavioral

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 Seminar

Behavioral

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.

Primary outcomes

  1. Disease activity

    Time frame: Measured at Week 12 and Months 4 and 8 follow-up

  2. Health functioning

    Time frame: Measured at Week 12 and Months 4 and 8 follow-up

  3. 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

Secondary outcomes

  1. Mood disturbances

    Time frame: Measured at Week 12 and Months 4 and 8 follow-up

  2. Coping

    Time frame: Measured at Week 12 and Months 4 and 8 follow-up

  3. Helplessness

    Time frame: Measured at Week 12 and Months 4 and 8 follow-up

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Behavioral Treatments for Rheumatoid Arthritis

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 10, 2003
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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