Clinical trial NCT00869349: Living Well With Rheumatoid Arthritis
Official title: Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
IFS
psychosocial
social support
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-03-26
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: RADAI Disease Activity Score
timeFrame: 21 months
Secondary outcomes:
measure: Depression
timeFrame: 21 months
measure: Self-Compassion
timeFrame: 21 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Nancy A Shadick, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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