Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Pain severity, pain functional interference
研究概览
简要总结
Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.
详细描述
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.
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 (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
- •chronic pain diagnosis (ICD-9 diagnoses 338.xx)
- •treatment with prescription opioids for > 3 months
排除标准
- •prior mindfulness training
- •persons who are experiencing acute opioid withdrawal
- •suicidal ideation
- •psychosis
研究组 & 干预措施
Mindfulness-Oriented Recovery Enhancement
干预措施: Mindfulness-Oriented Recovery Enhancement (Behavioral)
Conventional Support Group (SG)
干预措施: Conventional Support Group (SG) (Behavioral)
结局指标
主要结局
Pain severity, pain functional interference
时间窗: Baseline, immediately following treatment, and at 3 month follow-up
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Opioid craving
时间窗: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Opioid misuse behaviors
时间窗: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Well-being
时间窗: Baseline, immediately following treatment, and at 3 month follow-up
Change in well-being as measured by the WHO-5
次要结局
- Psychophysiological cue-reactivity(Baseline and immediately following treatment)
- Emotional response inhibition(Baseline and immediately following treatment)
- Pain coping strategies(Baseline, intervention midpoint, and immediately following treatment)
- Anhedonia(Baseline and immediately following treatment)
- Fear of pain(Baseline and immediately following treatment)
- Mindfulness(Baseline, intervention midpoint, and immediately following treatment)
- Positive reappraisal(Baseline and immediately following treatment)
- Attentional bias(Baseline and immediately following treatment)
研究者
Eric Garland
Assistant Professor
Florida State University