Completed

Behavioral Treatments for Rheumatoid Arthritis

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What is being tested

Cognitive Behavioral Therapy

+ Tai Chi Chih

+ Health Education Seminar

Behavioral
Who is being recruted

Arthritis+16

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorUniversity of California, Los Angeles
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleBehavioral Treatments for Rheumatoid Arthritis
NCT00072657
Principal SponsorUniversity of California, Los Angeles
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesBehaviorBehavioral SymptomsChronic DiseaseConnective Tissue DiseasesDepressionImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsPainPathologic ProcessesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesDisease Attributes

Criteria

6 inclusion criteria required to participate
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

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11 exclusion criteria prevent from participating
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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will partake in cognitive behavioral therapy for 12 weeks.

Group II

Experimental
Participants will partake in tai chi chih for 12 weeks.

Group III

Active Comparator
Participants will act as a control and attend educational sessions for 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cousins Center for Psychoneuroimmunology, UCLA

Los Angeles, United StatesOpen Cousins Center for Psychoneuroimmunology, UCLA in Google Maps
CompletedOne Study Center