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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
  Purpose
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.

Condition Intervention
Rheumatoid Arthritis Behavioral: IFS Other: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.

Resource links provided by NLM:


Further study details as provided by Nancy Shadick, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Enrollment: 79
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFS Intervention Group 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.

Active Comparator: Education Group 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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869349


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Parker, J. C., K.L. Smarr, S.P. Bucklew, R.C. Stucky-Ropp, J.E. Hewett (1995).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Shadick, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00869349     History of Changes
Other Study ID Numbers: 2002-P-001762
First Submitted: March 25, 2009
First Posted: March 26, 2009
Results First Submitted: January 23, 2014
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: January 2017

Keywords provided by Nancy Shadick, Brigham and Women's Hospital:
Rheumatoid Arthritis
IFS
psychosocial
social support

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases