NCT00072657

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2004

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

5.1 years

First QC Date

November 7, 2003

Last Update Submit

April 1, 2013

Conditions

Rheumatoid Arthritis

Keywords

ArthritisPainMeditationTai ChiChronic IllnessDepression

Outcome Measures

Primary Outcomes (3)

  • Disease activity

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

  • Health functioning

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

  • 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

Secondary Outcomes (3)

  • Mood disturbances

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

  • Coping

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

  • Helplessness

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

Study Arms (3)

1

EXPERIMENTAL

Participants will partake in cognitive behavioral therapy for 12 weeks.

Behavioral: Cognitive Behavioral Therapy

2

EXPERIMENTAL

Participants will partake in tai chi chih for 12 weeks.

Behavioral: Tai Chi Chih

3

ACTIVE COMPARATOR

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

Behavioral: Health Education Seminar

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

1
Tai Chi ChihBEHAVIORAL

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.

2
Health Education SeminarBEHAVIORAL

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.

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cousins Center for Psychoneuroimmunology, UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • Azizoddin DR, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic status, reserve capacity, and depressive symptoms predict pain in Rheumatoid Arthritis: an examination of the reserve capacity model. BMC Rheumatol. 2024 Sep 20;8(1):46. doi: 10.1186/s41927-024-00416-4.

    PMID: 39304956DERIVED

  • Azizoddin D, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic Status, Reserve Capacity, and Depressive Symptoms Predict Pain in Rheumatoid Arthritis: An Examination of the Reserve Capacity Model. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2758092. doi: 10.21203/rs.3.rs-2758092/v1.

    PMID: 37066198DERIVED

  • Ormseth SR, Draper TL, Irwin MR, Weisman MH, Arechiga AE, Hartoonian N, Bui T, Nicassio PM. Multidimensional Model of Disability and Role Functioning in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1686-92. doi: 10.1002/acr.22658.

    PMID: 26212464DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritisPainChronic DiseaseDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Perry M. Nicassio, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 7, 2003

First Posted

November 10, 2003

Study Start

February 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)