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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Tai Chi Chih
Health Education Seminar
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Pain, Meditation, Tai Chi, Chronic Illness, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cousins Center for Psychoneuroimmunology, UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will partake in cognitive behavioral therapy for 12 weeks.

Participants will partake in tai chi chih for 12 weeks.

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

Outcomes

Primary Outcome Measures

Disease activity
Health functioning
Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha

Secondary Outcome Measures

Mood disturbances
Coping
Helplessness

Full Information

First Posted
November 7, 2003
Last Updated
April 1, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00072657
Brief Title
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
Official Title
Behavioral Treatments for Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, Pain, Meditation, Tai Chi, Chronic Illness, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will partake in cognitive behavioral therapy for 12 weeks.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will partake in tai chi chih for 12 weeks.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will act as a control and attend educational sessions for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chih
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Seminar
Intervention Description
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 Outcome Measure Information:
Title
Disease activity
Time Frame
Measured at Week 12 and Months 4 and 8 follow-up
Title
Health functioning
Time Frame
Measured at Week 12 and Months 4 and 8 follow-up
Title
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 Outcome Measure Information:
Title
Mood disturbances
Time Frame
Measured at Week 12 and Months 4 and 8 follow-up
Title
Coping
Time Frame
Measured at Week 12 and Months 4 and 8 follow-up
Title
Helplessness
Time Frame
Measured at Week 12 and Months 4 and 8 follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry M. Nicassio, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cousins Center for Psychoneuroimmunology, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26212464
Citation
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.
Results Reference
derived

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

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