Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Brief Pain Inventory
研究概览
简要总结
The purpose of this pilot feasibility study is to evaluate the effects of a smartphone-based mindfulness intervention (MBI) on pain-related outcomes in individuals with fibromyalgia. This 8-week randomized controlled trial will compare an MBI app group to a control group who completes assessments only through the app.
The MBI intervention includes weekly video content focused on mindfulness practice and psychoeducation, combined with daily symptom tracking through the app. Participants in both groups will complete self-report measures at baseline, post-intervention, and follow-ups at 3 and 6 months.
The study will enroll up to 100 participants from Brigham and Women's Hospital and the greater Boston area. This pilot study is designed to assess feasibility and explore preliminary effects on outcomes such as pain interference, fibromyalgia symptoms, pain catastrophizing, sleep disturbance, emotional distress, mindfulness, and pain acceptance. Results will be used to inform the design of a future fully powered randomized trial.
详细描述
Mindfulness-based interventions have shown promise in improving symptoms of chronic pain, including fibromyalgia, through mechanisms such as increased pain acceptance, reduced catastrophizing, and enhanced emotional regulation. Delivering such interventions via smartphone application increases accessibility and scalability, particularly for individuals who face mobility or geographic barriers to in-person treatment.
This study uses a parallel-group randomized controlled design. Participants will be assigned to either the MBI intervention group or a control group. The intervention group will receive access to weekly mindfulness practice and psychoeducation videos through a smartphone app over the course of 8 weeks, in addition to daily symptom tracking and weekly assessments. The control group will use the same app to complete assessments only.
Primary outcomes include feasibility and clinical variables including pain interference, fibromyalgia symptoms, and pain catastrophizing. Secondary outcomes include sleep disturbance, anxiety, depression, pain acceptance, and mindfulness.
Assessments will be collected at baseline and after the 8-week intervention, with additional follow-ups at 3 and 6 months post-intervention to examine sustained effects. All study procedures, including informed consent, intervention delivery, and assessments, will occur remotely through the app or secure platforms.
The results of this study will offer insight into the acceptability, engagement, and preliminary efficacy of smartphone-based mindfulness interventions for fibromyalgia and guide development of a larger confirmatory trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65
- •Diagnosis of fibromyalgia per Wolfe et al. (2011) criteria
- •Stable medication regimen or medication-free
- •Fluent in English
- •Able to provide informed consent
排除标准
- •Comorbid pain condition more severe than fibromyalgia
- •Pregnancy or breastfeeding
- •Current psychosis or history of severe psychiatric illness
- •Active suicidal ideation
- •Participation in another therapeutic trial
- •Any condition that may interfere with study compliance as judged by the PI or study coordinator
研究组 & 干预措施
Mindfulness-Based Intervention (MBI)
Participants in this group will receive access to a smartphone app delivering an 8-week mindfulness-based intervention. The app includes weekly video modules (mindfulness practice and psychoeducation), daily pain tracking, and weekly assessments.
干预措施: Mindfulness Intervention (Behavioral)
Control
Participants in this group will complete the same daily and weekly assessments via the smartphone app but will not have access to the mindfulness or psychoeducation content.
结局指标
主要结局
Change in Brief Pain Inventory
时间窗: Daily for 8-weeks
Assessed using the Brief Pain Inventory - Pain Interference Subscale
次要结局
- Change in Pain Catastrophizing (PCS)(Baseline and post (8 weeks))
- Pain Acceptance (CPAQ-R)(Baseline and post (8 weeks))
- Mindfulness (MAAS)(Baseline and post (8 weeks))
- Qualitative Exit Interviews(Post (after 8-weeks))
- Change in Fibromyalgia Symptoms (FIQR)(Weekly for 8-weeks)
- Anxiety and Depression (PROMIS-A/D)(Baseline and post (8 weeks))
研究者
Asimina Lazaridou, PhD
Assistant Professor of Anesthesiology
Brigham and Women's Hospital