Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in momentary craving
研究概览
简要总结
This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain 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)
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 determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
- •Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
- •Willingness to participate in study interventions and assessments
排除标准
- •Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- •Active suicidality, schizophrenia, psychotic disorder
- •Presence of clinically unstable systemic illness judged to interfere with treatment
- •No access to internet (which will prevent telehealth-based treatment)
研究组 & 干预措施
Mindfulness-Oriented Recovery Enhancement+JITAI
Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks.
干预措施: MORE+JITAI (Behavioral)
Supportive Psychotherapy
Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks.
干预措施: Supporive Psychotherapy (Behavioral)
结局指标
主要结局
Change in momentary craving
时间窗: Baseline through 1-month follow-up
Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)
Change in momentary pain: numeric rating scale
时间窗: Baseline through 1-month follow-up
Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)
次要结局
- Change in momentary stress(Baseline through 1-month follow-up)
- Change in momentary positive affect(Baseline through 1-month follow-up)
- Change in heart rate variability(Baseline through 1-month follow-up)
研究者
Eric Garland
Professor
University of Utah