Digital Tools for Coping With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 13
- 主要终点
- Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months
研究概览
简要总结
Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid psychological distress are also commonly found among individuals living with chronic pain. Often requiring a multi-modal treatment approach, a growing body of literature suggests that digital behavioral health interventions and tools may serve as promising complementary options to help individuals cope with the pain.
详细描述
The research objective is to evaluate the effectiveness of the myStrength product offerings, namely the chronic pain focus area, on study participants' functional well-being over time. The research questions to be answered include the following:
- Do study participants who are randomized to the myStrength intervention arm experience change in their self-reported ability to function, outlook on pain, and/or perception of prescription opioids.
- Do study participants who are randomized to the myStrength intervention arm experience change in terms of their behavioral health, such as anxiety and depression levels, during the study period.
The study team hypothesizes that myStrength study participants will achieve a higher level of functioning and adopt a more positive outlook toward their pain management as compared to the waitlist control group. Self-assessments will be repeated throughout the study period to capture the inflection point of change as well as the sustainability of these changes over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants must be 18 years of age or older
- •Self-report chronic pain lasting for at least the past 3 months but no more than 9 months (examples include lower back pain, arthritis, chronic headaches, neuropathic pain, knee pain)
- •Must have considered, have a history of, or are currently taking a prescription opioid for chronic pain (examples oxycodone (OxyContin, Percodan, Percocet), hydrocodone (Vicodin, Lortab, Lorcet), morphine (Kadian, Avinza, MS Contin), fentanyl (Duragesic), propoxyphene (Darvon), hydromorphone (Dilaudid)
- •Fluent in English and articulate Access to a laptop or mobile device to access email and the myStrength platform
排除标准
- •Under the age of 18
- •Chronic pain due to cancer
- •Chronic pain <3 months or > 9 months
- •Prior exposure to the myStrength platform
- •Self-reported history of hospitalization for mental illness or a substance use disorder
- •Receiving government benefits related to a developmental or behavioral health disability
研究组 & 干预措施
myStrength Intervention
The myStrength intervention arm will be encouraged to utilize the chronic pain offering consisting of 6 modules. Each module has 5 activities and can take on average 5-15 minutes to complete. Study participants assigned to the myStrength intervention will have one week to complete each module. In addition to completing the required chronic pain modules, study participants in the myStrength intervention arm will have the option to also select other areas of interest and complete corresponding activities at their own pace. myStrength utilization will be recorded and analyzed.
干预措施: myStrength (Behavioral)
Waitlist Control
The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.
结局指标
主要结局
Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months
时间窗: Repeated measures over time: baseline and day 180
Measure ability to function in the presence of chronic pain
次要结局
- Change in baseline and GAD7 at 6 months(Repeated measures over time: baseline and day 180)
- Change in baseline PHQ9 at 6 months(Repeated measures over time: baseline and day 180)
- Change in baseline Current Opioid Misuse Measure at 6 months(Repeated measures over time: baseline and day 180)
- Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months(Repeated measures over time: baseline and day 180)