Feasibility of Mindfulness Meditation Training and Home Practice in Persons with Spinal Cord Injury: A Pilot Study

脊髓损伤患者正念冥想训练和家庭练习的可行性：试点研究

• 批准号: 10454632
• 负责人: Radha Korupolu
• 金额: $ 25.4万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-16 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10454632
• 关键词: Adherence; Adjuvant; Affect; Antidepressive Agents; Antiepileptic Agents; Anxiety; Award; COVID-19; Clinical; Clinical Trials; Communities; Consent; Constipation; Data; Data Collection; Diagnosis; Educational Intervention; Exercise; Face; Feedback; Funding; Goals; Grant; Healthcare Systems; Home; Impaired cognition; Individual; International; Internet; Intervention; Life; Measures; Medicine; Meditation; Mental Depression; Mental Health; Opioid; Outcome; Pain; Pain interference; Pain management; Pain quality; Participant; Patient Outcomes Assessments; Persistent pain; Persons; Pharmaceutical Preparations; Pharmacology; Physical Medicine; Physiological; Pilot Projects; Population; Prevalence; Procedures; Proliferating; Protocols documentation; Psyche structure; Public Health; Quality of life; Randomized; Reporting; Research; Research Assistant; Research Personnel; Risk; Running; Sedation procedure; Seeds; Self Care; Spinal cord injury; Spinal cord injury patients; Surveys; Telemedicine; Therapeutic; Time; Training; Translating; United States Department of Veterans Affairs; Visit; Withdrawal; Work; acceptability and feasibility; active control; addiction; adherence rate; base; chronic pain; chronic pain management; college; comparison intervention; cost; design; efficacy evaluation; efficacy study; efficacy trial; experience; follow up assessment; follow-up; handheld mobile device; health care availability; health related quality of life; improved; innovation; mindfulness; mindfulness meditation; mobile application; multidisciplinary; online delivery; pain outcome; pain reduction; pain relief; pain self-management; physical symptom; post intervention; primary outcome; recruit; remote delivery; response; retention rate; satisfaction; secondary outcome; side effect; tool

Project Summary: The prevalence of debilitating chronic pain in people with spinal cord injury (SCI) ranges from 65-85%. Chronic pain after SCI contributes to anxiety, depression and diminishes the health-related quality of life (QOL). Pharmacological agents such as opioids are the primary therapeutic options to manage chronic pain after SCI, but are ineffective in relieving pain and associated with significant side effects. Mindfulness meditation training (MM) has been shown to improve mental and physical symptoms, including pain-related interference, in many studies of people without SCI who have chronic pain. However, these interventions are typically lengthy, expensive, and require in-person visits with a therapist, making them inaccessible to many people with SCI. Mounting evidence suggests that mobile apps may provide an effective and low-cost way to provide MM. Indeed, one recent study found that internet-based MM training led to reduced pain interference and improved mental health in people with SCI and chronic pain, suggesting app-based MM interventions may have promise in this population. However, this study used an intervention created by the researchers which is not currently available to the public for free, limiting large-scale dissemination. Additionally, the feasibility found in that study may not necessarily translate to that of an existing, publicly available app-based MM intervention among persons with SCI. Similarly, the feasibility of other app-based MM interventions for non-SCI populations may not translate to persons with SCI due to the specific physiological limitations experienced by person with SCI. Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app “Mindfulness Coach” developed by the Department of Veteran Affairs, or to view TED talks for ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, and quality of life. Given the great need for remotely delivered, low-cost chronic pain management and unique physiological limitations among person with SCI, it is essential to determine the feasibility and acceptability of a free, publicly available app-based MM intervention prior to conducting a larger efficacy study. With the emerging use of telemedicine in this COVID-19 era, therapy-focused apps and remote data collection are becoming increasingly popular making this line of inquiry both timely and innovative. Furthermore, the app-guided MM intervention has the potential to facilitate self-management of pain by persons with SCI, as the MM exercises can be practiced at the individual’s preferred time and place. The long-term goal of this study is to improve pain management and QOL of people with SCI living with chronic pain by identifying affordable and accessible app- guided interventions which can be used as an adjuvant tool after SCI in conjunction with other treatments.

项目摘要： 在脊髓损伤（SCI）患者中，慢性疼痛的患病率为65- 85%。慢性 脊髓损伤后的疼痛会导致焦虑、抑郁并降低健康相关的生活质量（QOL）。 阿片类药物是治疗SCI后慢性疼痛的主要治疗选择， 但在缓解疼痛方面无效并伴有显著的副作用。正念冥想训练 (MM)已被证明可以改善精神和身体症状，包括疼痛相关的干扰，在许多 研究对象是患有慢性疼痛的非脊髓损伤患者。然而，这些干预通常是漫长的， 昂贵，需要亲自拜访治疗师，使许多SCI患者无法获得。 越来越多的证据表明，移动的应用程序可能提供一种有效和低成本的方式来提供MM。 事实上，最近的一项研究发现，基于互联网的MM训练可以减少疼痛干扰， SCI和慢性疼痛患者的心理健康，表明基于应用程序的MM干预可能有希望 在这个人群中然而，这项研究使用了研究人员创造的干预措施，目前还没有 免费向公众提供，限制了大规模传播。此外，该研究发现的可行性 可能不一定转化为现有的、公开可用的基于应用程序的MM干预， SCI患者。类似地，其他基于应用程序的MM干预措施对非SCI人群的可行性可能 由于SCI患者所经历的特定生理限制，因此不适用于SCI患者。 我们的多学科，跨机构的研究小组建议随机选择60名SCI患者 使用免费应用程序，每天练习音频引导MM ≥ 10分钟，持续6周 退伍军人事务部开发的“正念教练”，或观看TED演讲≥ 10分钟 每天在免费的TED应用程序上进行6周（主动控制）。主要成果是可行性和 建议的干预措施在SCI和慢性疼痛患者中的可接受性。次要结局包括 收集患者报告的疼痛、焦虑、抑郁、正念和生活质量结果的可行性。 考虑到对远程递送、低成本慢性疼痛管理和独特的生理学治疗的巨大需求， 在SCI患者中，确定一个免费的， 在进行更大规模的疗效研究之前，公开提供基于应用程序的MM干预。随着新兴的使用 在这个COVID-19时代的远程医疗中，以治疗为重点的应用程序和远程数据收集正在成为 越来越受欢迎，使这条调查线既及时又创新。此外，APP引导的MM 干预有可能促进SCI患者自我管理疼痛，因为MM练习 可以在个人喜欢的时间和地点练习。这项研究的长期目标是改善疼痛 管理和生活质量的人与SCI慢性疼痛的生活通过确定负担得起的和可访问的应用程序， 指导性干预，可作为SCI后的辅助工具，与其他治疗结合使用。