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

Rheumatoid Arthritis Clinical Trial

Official title:

Behavioral Treatments for Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072657
• Other study ID #: R01AR049840
• Secondary ID: R01AR049840NIAMS
• Status: Completed
• Phase: N/A
• First received: November 7, 2003
• Last updated: April 1, 2013
• Start date: February 2004
• Est. completion date: March 2009

Study information

• Verified date: April 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cousins Center for Psychoneuroimmunology, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity		Measured at Week 12 and Months 4 and 8 follow-up	No
Primary	Health functioning		Measured at Week 12 and Months 4 and 8 follow-up	No
Primary	Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha		Measured at Week 12 and Months 4 and 8 follow-up	No
Secondary	Mood disturbances		Measured at Week 12 and Months 4 and 8 follow-up	No
Secondary	Coping		Measured at Week 12 and Months 4 and 8 follow-up	No
Secondary	Helplessness		Measured at Week 12 and Months 4 and 8 follow-up	No