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Living Well With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869349
First Posted: March 26, 2009
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
March 25, 2009
March 26, 2009
January 23, 2014
March 20, 2017
March 20, 2017
September 2008
December 2010   (Final data collection date for primary outcome measure)
RADAI Disease Activity Score [ Time Frame: 21 months ]

Change in self-assessed disease activity from baseline to 21-months. Total RADAI score is 0-10 with 0 indicating no/low self-assessed disease activity and 10 indicating high self-assessed disease activity.

Reference: Stucki G, Liang M, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiological research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 38;795-98,1995

  • Change in self-efficacy [ Time Frame: Baseline and at 3, 6 and 9 months ]
  • Improvement in health status and RA disease activity as documented by the swollen and tender joint count, crp level and VAS scores. [ Time Frame: Baseline, 6 and 9 months ]
Complete list of historical versions of study NCT00869349 on ClinicalTrials.gov Archive Site
  • Depression [ Time Frame: 21 months ]

    Change in the Beck Depression Scale from baseline to 21-months. The BDI-II (Reference: BDI- II Manual by Aaron T. Beck, Robert A. Steer, and Gregory K. Brown) is a 21-item scale for measuring negative attitudes about the future. Add up each of the items marked in the direction keyed for "hopelessness" to get a total score.

    Each of 21 items is summed to give single score for BDI-II.

    • There is 4-point scale ranging from 0 - 3. On 2 items (16, 18)
    • There are 7 options to indicate either increase or decrease of appetite and sleep. These are still scored 0 - 3 - answers are 0,1a,1b,2a,2b,3a,3b.
    • Cut score guidelines for the BDI-II are given with recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II.

      0 - 13 minimal 14 - 19 mild 20 - 28 moderate 29 - 63 severe

  • Self-Compassion [ Time Frame: 21 months ]
    Change in the Neff Self Compassion scale from baseline to 21-months. This is a 26-item scale. The total self-compassion score ranges from 0 (no self-compassion) - 30 (high self-compassion). Reference: Neff, K.D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250
Improvement in depression and anxiety scores as well as self compassion [ Time Frame: Baseline, 3, 6 and 9 months ]
Not Provided
Not Provided
 
Living Well With Rheumatoid Arthritis
Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.
The purpose of the Living Well with RA program is to perform a proof-of-concept study and evaluate the efficacy of an Internal Family Systems-based psychotherapeutic intervention improve Rheumatoid Arthritis subjects' disease activity, independence and other health outcomes. This study will also assess the efficacy of an IFS-based program in improving RA subjects' mental health symptoms. We hypothesize that the IFS model will improve RA subjects self-management of their disease and subsequently their health outcomes will improve as well as compared to a group focusing on arthritis education.

Subjects will be selected from the Brigham & Women's Hospital Arthritis Center and include those enrolled in the BRASS study and then once recruited randomly assigned to either the IFS intervention group or the education group. Both the IFS intervention and education group will participate in their respective programs simultaneously over 9 months.

Subject reported measures:

Incorporated into the questionnaires are several subject-reported measures, including: The Self-Compassion Scale, Beck Depression Index (BDI-II), SF-12 Health Survey, State-Trait Anxiety Inventory (STAI), RA Disease Activity Index (RADAI), and Arthritis Self-Efficacy Scale. These measures report emotional states, degree and location of arthritis pain, and how that pain affects their daily lives. A monthly encounter form will also be completed by the subject.

Physician measures:

The physicians who will be monitoring subject health are blind to the study and complete the same measures for subjects in both the IFS intervention and education groups. They will complete a joint count, Global Assessment of health, duration of morning stiffness and ACR functional status.

Laboratory testing:

Subjects will give blood at the beginning, 3, 6 and 9-month points of the program. This sample will be laboratory-tested for C-reactive protein.

Data collection schedule:

Subjects will complete a questionnaire at baseline, then at 3, 6 and 9 months. They will give blood samples and undergo a routine physical examination, focusing on their joints at the initial meeting, again at 3, 6, and 9 months into the study.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Rheumatoid Arthritis
  • Behavioral: IFS

    The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.

    Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline.

  • Other: Education
    The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
  • Experimental: IFS Intervention Group
    Intervention: Behavioral: IFS
  • Active Comparator: Education Group
    Intervention: Other: Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
December 2013
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active RA symptoms
  • Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
  • Ability to attend group and individual sessions consistently

Exclusion Criteria:

  • RA has been in remission for one year
  • Subjects who are currently enrolled in the Arthritis Foundation Self- Management course or any similar type of course
Sexes Eligible for Study: All
18 Years to 81 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00869349
2002-P-001762
No
Not Provided
Not Provided
Nancy Shadick, Brigham and Women's Hospital
Brigham and Women's Hospital
Bristol-Myers Squibb
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP