Living Well With Rheumatoid Arthritis

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Behavioral: IFS
Other: Education

Registration Number: NCT00869349

Lead Sponsor: Brigham and Women's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 79

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFS Intervention Group	IFS	-
Education Group	Education	-

Primary Outcome Measures

Name	Time	Method
RADAI Disease Activity Score	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

Name	Time	Method
Depression	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	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