Brief MORE: A Mindfulness Intervention For Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. There are three treatment conditions in this study: two different brief pain management trainings and one standard-length training. Participants will be randomized to either of the brief trainings, attending a single, 2-hour, online training session, in which a trained facilitator will teach pain management techniques that are backed by research. If randomized to receive the standard-length training, participants will attend eight, 2-hour, online training session over eight weeks, in which a trained facilitator will also teach research-backed pain management techniques. Short surveys will be required at seven different time points: before starting treatment, immediately after the pain-management training, and then 2, 6, 12, 24, and 36 weeks after the training.
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
- Single (Investigator)
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
- •(1) having a chronic musculoskeletal pain condition, (2) average pain of ≥ 3 in the previous week, (3) willingness to engage with study assessments and interventions, (4) understanding English instructions fluently, and (5) being 18 and above.
排除标准
- •(1) unable to consent because of physical or mental incapacity, (2) have previous, formal mindfulness training (e.g., MBSR) or previously receiving Empowered Relief, (3) have pain from a current cancer diagnosis or cancer-related treatment, (4) unstable illness that may interfere with treatment, (5) had surgery within the previous three months, and (6) had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
结局指标
主要结局
Recruitment Feasibility
时间窗: 6 months
Recruitment feasibility will be assessed via total enrollment and randomization numbers within the first 6 months of the study. Study team projects that it will be feasible to recruit and randomize 30 adults with CMP within 6 months.
Treatment Adherence & Acceptability
时间窗: From baseline to 9-month follow-up
Adherence (percentage of total treatment time attended) will be better for the single-session interventions, but all three conditions will be rated as highly acceptable (as measured by the Theoretical Framework of Acceptability; TFA).
次要结局
- PROMIS - Pain Intensity(From baseline to 9-month follow-up)
- PROMIS - Pain Interference(From baseline to 9-month follow-up)
研究者
Adam Hanley
Assistant Professor
Florida State University