Spanish Language Adaptation of One MORE for Chronic Pain in Latinos
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain Intensity & Interference
研究概览
简要总结
This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Spanish-speaking
- •Diagnosed with a chronic pain condition
- •Average pain in the previous week > or = 3
- •Willingness to participate in study interventions and assessments.
排除标准
- •Non Spanish-speaking
- •Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
- •Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
- •Presence of clinically unstable illness judged to interfere with treatment or study procedures
- •Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
- •Communication or cognitive impairment that limits participation in treatment or study procedures.
结局指标
主要结局
Pain Intensity & Interference
时间窗: Will be completed at baseline, week 2, and week 6.
Change in pain intensity and interference from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 30, with higher scores reflecting greater pain intensity/interference.
次要结局
- Acceptability(Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.)
- Acute Pain(Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.)
研究者
Eric Garland
Professor
University of Utah