Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Chronic Pain
研究概览
简要总结
The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators, study staff, and statistician will 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
- •Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
- •Prescribed long-term opioid therapy (≥3 months)
- •Score >=3 on the Pain Enjoyment General Activity scale
- •Score >=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use
排除标准
- •Chronic pain due to a cancer diagnosis
- •Active suicidal intent, schizophrenia, psychotic disorder
- •Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement
研究组 & 干预措施
Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider.
干预措施: Mindfulness Oriented Recovery Enhancement (Behavioral)
Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider.
干预措施: Patient-Centered Chronic Pain Management Visits (Behavioral)
Patient-centered chronic pain management visits
Participants will attend patient-centered chronic pain management visits led by their primary care provider.
干预措施: Patient-Centered Chronic Pain Management Visits (Behavioral)
结局指标
主要结局
Chronic Pain
时间窗: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Change in Chronic pain will be measured from baseline through study completion using the Pain, Enjoyment of Life, and General Activity Scale (PEG). Scoring can be determined in one of two ways: 1. A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities 2. Dividing the sum of responses to all three items by 3 to get the mean score on a scale of 0-10, with higher scores indicating more severe pain and pain-related interference with life and activities.
Opioid Misuse
时间窗: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid misuse as evidenced by triangulated aggregate of self-reported Current Opioid Misuse Measure and/or interview via Addiction Behaviors Checklist and/or urine screen
次要结局
- PTSD Symptoms(Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up))
- Opioid Dosing(Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up))
- Generalized Anxiety(Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up))
- Change in Quality of Life(Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up))
- Opioid Craving(Daily from baseline through month 4)
- Depression(Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up))
研究者
Eric Garland
Professor, Principal Investigator
University of Utah