Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The investigators will implement an international 2-arm online pragmatic feasibility randomized controlled trial (RCT) of a digital pain relief skills intervention "Empowered Relief: On-Demand" to reduce pain metrics, opioid craving, and opioid misuse. They will compare Empowered Relief to a no-skills digital health education ("Living Better") intervention in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.
详细描述
Most people who misuse prescription opioids report doing so for pain relief. This study will investigate a digital intervention for people with comorbid chronic pain and opioid misuse.
The intervention, Empowered Relief On-Demand, will include roughly 80 minutes of interactive digital pain education and pain management skills content with multimedia features and an App. The investigators will conduct a fully online 2-arm RCT of digital Empowered Relief in a national sample of people with comorbid chronic pain and opioid misuse compared to a digital health education control (HE).
The investigators will implement The MOBILE Relief Study, an international (United States, Canada, United Kingdom, and Australia) 2-arm online feasibility RCT of Empowered Relief to reduce pain intensity, pain interference, pain-related distress (pain outcomes) and opioid outcomes (opioid craving and misuse) in people with prescription opioid misuse and chronic pain. They will compare Empowered Relief On Demand to an interactive digital health education (HE) intervention that is devoid of pain management skills ("Living Better") in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey (received immediately following treatment completion) is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with five items (overall satisfaction with treatment, ease of understanding, relevance, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, and months 1, 2, and 3. At post-treatment weeks 1 and 2, electronic surveys will measure opioid craving, pain intensity, pain catastrophizing (distress), and pain interference.
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 (Participant, Investigator)
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
- •Male and females 18 years of age or older
- •Chronic non-cancer pain (at least 6 months in duration)
- •Average pain intensity of at least 3 on the PROMIS SFV1.0 Pain Intensity 1a
- •Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
- •Opioid misuse (at least 6 on the Current Opioid Misuse Measure; COMM)
- •English fluency
- •Internet access
排除标准
- •Gross cognitive impairment
- •Inability to complete study electronic surveys
- •Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention
结局指标
主要结局
Pain intensity
时间窗: post-treatment month 3
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Opioid craving
时间窗: post-treatment months 3 (Secondary Endpoint)
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Current prescription opioid misuse
时间窗: post-treatment month 3 (Secondary Endpoint)
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Pain interference
时间窗: post-treatment month 3
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Treatment engagement
时间窗: Immediately post-treatment (Primary Outcome)
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
Pain catastrophizing
时间窗: post-treatment months 3
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Opioid use
时间窗: Baseline to post-treatment month 3
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Treatment appraisal
时间窗: Immediately post-treatment (Primary Outcome)
5 items assess satisfaction and perceived utility of assigned treatment (7-point scale where 0 = "not at all satisfied" to 6 = "extremely satisfied"). Higher scores indicate higher satisfaction with the assigned treatment.
次要结局
未报告次要终点
研究者
Beth Darnall
Principal Investigator
Stanford University