Living Well With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): IFS; Education
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Rheumatoid Arthritis; IFS; psychosocial; social support