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Behavioral Treatments for Rheumatoid Arthritis

18 Years
Not Enrolling
Rheumatoid Arthritis

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Trial Information

Behavioral Treatments for Rheumatoid Arthritis

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Disease activity

Outcome Time Frame:

Measured at Week 12 and Months 4 and 8 follow-up

Safety Issue:


Principal Investigator

Perry M. Nicassio, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Federal Government

Study ID:

R01 AR49840



Start Date:

February 2004

Completion Date:

March 2009

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Pain
  • Meditation
  • Tai Chi
  • Chronic Illness
  • Depression
  • Arthritis
  • Arthritis, Rheumatoid



Cousins Center for Psychoneuroimmunology, UCLA Los Angeles, California  90095