Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Pain Interference
研究概览
简要总结
This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •age>18yo
- •Chronic Low Back Pain as seen on medical history as well as score of >3 on pain visual analog scale (VAS) at the start of experimental sessions.
- •receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider.
- •willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider)
- •able and willing to perform/tolerate pain procedures (e.g., QST)
- •able to communicate fluently in English
- •able to use a smartphone or laptop for the virtual therapy program
排除标准
- •Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants;
- •Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition;
- •regular meditation practice
- •cognitive impairment
- •pregnancy
- •lack of English fluency
- •severe OUD
- •inability to provide informed consent.
研究组 & 干预措施
Mindfulness-Oriented Recovery Enhancement: (MORE) group
干预措施: Mindfulness-Oriented Recovery Enhancement: (MORE) group (Behavioral)
Psychoeducation
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Pain Interference
时间窗: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Brief pain interventory
Opioid Dose
时间窗: Baseline, 8 weeks, 3 month and 6 month follow up
assessed through their medical record
次要结局
- Opioid Misuse(Baseline, 8 weeks, 3 month and 6 month follow up)
- Opioid Craving(Baseline,8 weeks, 3 month and 6 month follow up)
- Opioid Withdrawal(Baseline, 8 weeks, 3 month and 6 month follow up)
- Pain Intensity(Baseline, 8 weeks, 3 month and 6 month follow up)
研究者
Asimina Lazaridou, PhD
Instructor
Brigham and Women's Hospital