Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Rheumatoid Arthritis
- 发起方
- Brigham and Women's Hospital
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- RADAI Disease Activity Score
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
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.
详细描述
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.
研究者
Nancy Shadick
Associate Professor
Brigham and Women's Hospital
入排标准
入选标准
- •Active RA symptoms
- •Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
- •Ability to attend group and individual sessions consistently
排除标准
- •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
结局指标
主要结局
RADAI Disease Activity Score
时间窗: 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
次要结局
- Depression(21 months)
- Self-Compassion(21 months)