Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Blood oxygenation level dependent (BOLD) signaling
研究概览
简要总结
The primary aim of this pilot trial is to enhance the efficacy of the Mindfulness-Oriented Recovery Enhancement (MORE) intervention by adding neurofeedback (NF) of the Orbitofrontal Cortex (OFC) as an adjunct to the savoring component of MORE. We hypothesize that the use of NF to train OFC responses during savoring will amplify patients' ability to savor and thereby increase brain responsivity to natural rewards; such enhanced reward responding will in turn be associated with improvements in clinical outcomes (e.g., pain, analgesic use).
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
- •≥18 years of age,
- •ability to understand and speak the English language
- •current chronic pain-related diagnosis
排除标准
- •mindfulness training experience (e.g., participation in MBSR/MBRP)
- •neurofeedback experience
- •current cancer diagnosis
- •having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication)
- •suicidal ideation with a plan in the past week, or a suicide attempt in the past 3 months
- •unwilling, unable, or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
- •communication or cognitive impairment that limits participation in group treatment or study procedures
结局指标
主要结局
Blood oxygenation level dependent (BOLD) signaling
时间窗: From baseline to immediately after the intervention.
Changes in blood oxygenation levels to reward cues will be assessed, and planned comparisons will be performed between subjects receiving MORE+NF vs the control conditions.
次要结局
- Chronic pain symptoms(From baseline to 3-month follow-up.)
- Pleasant sensation ratio(From baseline to immediately after intervention.)
- Opioid misuse(From baseline to 3-month follow-up.)
- Opioid dose(From baseline to 3-month follow-up.)
- Savoring(From baseline to 3-month follow-up.)
- Pleasure ratings(From baseline to immediately after intervention.)
- Distress(From baseline to 3-month follow-up.)
- Self-transcendence(From baseline to 3-month follow-up.)
- Opioid craving(From baseline to 1-month follow-up.)
- Positive affect(From baseline to 1-month follow-up.)