Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain Conditions and Opioid Related Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Change in pain severity and interference
研究概览
简要总结
The central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and Veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men/women ≥18 years of age
- •ability to understand and speak the English language
- •current chronic pain diagnosis (including but not limited to ICD-9 diagnoses 338.0, 338.2xx,
- •current use of prescription opioids for >3 consecutive months.
排除标准
- •Mindfulness training experience (participation in MBSR/MBRP)
- •opioid withdrawal evidenced by score ≥13 on the Clinical Opiate Withdrawal Scale
- •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
结局指标
主要结局
Change in pain severity and interference
时间窗: Baseline, and through 6 months post-treatment
Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)
Change in opioid misuse
时间窗: Baseline, and through 6 months post-treatment
Change in Current Opioid Misuse Measure from baseline through study completion (6 months post-treatment). Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
次要结局
- Change in post-traumatic stress(Baseline, and through 6 months post-treatment)
- Change in resilience(Baseline, and through 6 months post-treatment)
- Change in opioid dose (in morphine equivalents)(Baseline, during treatment, and through 6 months post-treatment)
- Change in psychological distress(Baseline, and through 6 months post-treatment)
- Change in opioid craving(Baseline, during treatment)