Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study
研究概览
简要总结
This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:
- Assess patient satisfaction with a mindfulness course
- Identify barriers to participation in, or completion of, a mindfulness course
- Gather initial information to understand how a mindfulness course impacts RA symptoms
Participants will:
- Complete online questionnaires
- Attend two in-person study visits, involving a brief joint exam and blood draw
- Roughly half the participants will have the chance to participate in an 8-week online mindfulness course
- Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course
Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.
详细描述
Participants will complete an initial eligibility screening, and if they are eligible, they will meet with a study staff member to review study procedures and answer any questions they might have about participating. If they would like to participate following this meeting, they will provide written consent and be enrolled in the study. Following enrollment, participants will complete an in-person study visit that will last up to one hour and include a brief joint exam, blood draw, and questionnaires. After this study visit, they will be randomly assigned to "treatment-as-usual" (TAU) or the mindfulness group. If assigned to the mindfulness group, they will participate in an 8-week online mindfulness course and online focus group following the course. All participants will complete a final in-person study visit at the end of the study, which will mimic the procedures of the first study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-confirmed diagnosis of rheumatoid arthritis (RA)
- •Access to a web-enabled computer, smartphone, or tablet
排除标准
- •RA disease activity in remission
- •Current regular mindfulness practice (> 20 minutes per week)
- •Inability to participate in an intensive 8-week online mindfulness course
- •Prior participation in a mindfulness-based stress reduction (MBSR) course
研究组 & 干预措施
Treatment as Usual (TAU)
Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial.
Mindfulness Program
Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD).
干预措施: Mindfulness Program (Behavioral)
结局指标
主要结局
Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study
时间窗: 8 weeks
A modified version of the 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to evaluate acceptability of the mindfulness program by patients in the treatment group. A few of the words in the original CSQ-8 were changed to make the questions relevant to the mindfulness program. Scores on the CSQ-8 range from 8-32, with higher scores indicating greater satisfaction. Scores ≥ 24 indicate adequate satisfaction. We are reporting the number and percentage of MBSR-RD participants with CSQ-8 scores ≥ 24, consistent with adequate satisfaction.
次要结局
- MBSR Course Attendance (Intervention Adherence)(8 weeks)
- Percent of Study Completers (Study Retention)(8 weeks)