An adaptive walking intervention to manage chronic pain in veterans with opioid use disorder engaged in opioid agonist treatment

一种适应性步行干预措施，用于治疗接受阿片类激动剂治疗的阿片类药物使用障碍退伍军人的慢性疼痛

• 批准号: 10657333
• 负责人: Robert Ross MacLean
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10657333
• 关键词: Aftercare; Award; Behavior; Behavior Therapy; Behavioral; Buprenorphine; Caring; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Coping Skills; Data Analyses; Diagnosis; Dose; Ecological momentary assessment; Education; Effectiveness; Elements; Epidemic; Evaluation; Evidence based treatment; Exclusion; Exposure to; Feasibility Studies; Foundations; Future; General Population; Goals; Guidelines; Health education; Individual; Intervention; Knowledge; Measurement; Measures; Mentors; Methadone; Methodology; Movement; Outcome Study; Pain; Pain interference; Pain management; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Population; Prayers; Prevalence; Procedures; Quality of life; Randomized; Recommendation; Reporting; Research; Resource-limited setting; Resources; Sampling; Scientist; Self Care; Strategic Planning; Substance Use Disorder; Surveys; Testing; Time; Training; Treatment outcome; United States; Veterans; Veterans Health Administration; Visit; Walking; acceptability and feasibility; biopsychosocial; care seeking; chronic pain; chronic pain management; chronic pain patient; clinical care; cost; disability; drug seeking behavior; evidence base; experience; follow up assessment; follow-up; handheld mobile device; improved; innovation; medical specialties; opioid agonist therapy; opioid overdose; opioid use; opioid use disorder; overdose death; pain reduction; patient engagement; pedometer; prescription opioid; primary outcome; satisfaction; screening; social stigma; therapy development; treatment group; walking intervention; walking program

Compared to a civilian population, Veterans have particularly high rates of severe chronic pain and Opioid Use Disorder (OUD). Prevalence of chronic pain in individuals with OUD remains high despite engagement in opioid agonist treatment (OAT), the first line treatment for OUD, consisting of buprenorphine or methadone. Chronic pain treatment in the Veterans Health Administration (VHA) has recently shifted to promoting non-pharmacologic approaches to treat chronic pain; however, individuals with OUD are often excluded from pain treatment clinical trials. Among individuals with chronic pain and OUD receiving OAT, the most commonly reported pain coping strategies are prayer, over the counter medication, and opioid medication. There is an immediate need to develop evidence-based pain treatments for chronic pain that can be integrated into OAT for Veterans with chronic pain and OUD. The gold standard non-pharmacologic treatment for chronic pain is cognitive behavioral therapy (CBT) for chronic pain. Despite having a favorable view of non-pharmacologic pain treatment, many OAT clinics lack adequate staffing training and resources for intensive pain treatment such as CBT. Furthermore, Veterans are often hesitant to seek care in pain specialty clinics due to stigma (e.g., drug-seeking behavior) and frequent OAT dosing visits. Walking is a core component of CBT for chronic pain and has demonstrated effectiveness at reducing pain in chronic pain patients. More specifically, walking has been identified as a low-cost, highly accessible intervention that has been shown to reduce pain, disability, and increase quality of life in individuals with chronic pain but has not been tested in Veterans with OUD engaged in OAT. The proposed study will determine feasibility, acceptability, and preliminary efficacy for Steps to Change (S2C), a behavioral pain treatment that includes biopsychosocial pain education and an adaptive walking program. Importantly, S2C will be offered within in the Veteran’s OAT clinic to increase access and encourage treatment engagement. Pain interference (primary outcome) collected using ecological momentary assessment (EMA), where behavior is repeatedly sampled using a mobile device. The use of EMA to measure pain interference offers considerable benefits to in-clinic measurement including significantly reducing recall bias and substantially improving reliability of measurement. Daily steps will be measured using a study provided pedometer and entered in end of day EMA surveys. Sixty Veterans will be randomized to either 1) S2C or 2) health education control each consisting of 4x60 minute weekly groups in the OAT clinic. All participants will complete EMA surveys for 8 weeks (1-week baseline, 4-week treatment, and 1-week post, 3- and 6-month follow up). We predict that study procedures will be feasible with timely randomization, comparable retention and EMA survey completion between treatment groups. We also predict that Veterans in both groups will rate treatment as satisfying and credible with Veterans randomized to S2C reporting greater average steps per day at post-treatment. Finally, we predict that Veterans receiving S2C will report lower pain interference (vs. health education) at post-treatment and 3- and 6-month follow-up. There is an urgent need for accessible, evidence-based pain treatments that can be integrated within the VHA’s specialized OAT clinic and substance use disorders clinics. This treatment will serve a focused exposure to chronic pain treatment, not as a replacement for CBT for chronic pain. To date, a walking intervention has not been evaluated in Veterans with OUD receiving OAT, a population with high rates of untreated chronic pain that are often excluded from pain treatment studies.

与平民相比，退伍军人患严重慢性疼痛的比率特别高， 阿片类药物使用障碍。OUD患者的慢性疼痛患病率仍然很高， 参与阿片类激动剂治疗（OAT），OUD的一线治疗，包括丁丙诺啡或 美沙酮退伍军人健康管理局（VHA）的慢性疼痛治疗最近转移到 促进非药物方法治疗慢性疼痛;然而，OUD患者通常 从疼痛治疗临床试验中排除。在接受OAT治疗的慢性疼痛和OUD患者中， 最常见的疼痛应对策略是祈祷，非处方药和阿片类药物 药有一个迫切需要开发基于证据的疼痛治疗慢性疼痛，可以 纳入OAT，用于患有慢性疼痛和OUD的退伍军人。 慢性疼痛的金标准非药物治疗是认知行为疗法（CBT） 治疗慢性疼痛尽管对非药物性疼痛治疗有着良好的看法，但许多OAT诊所缺乏 足够的人员培训和资源，用于强化疼痛治疗，如CBT。此外，退伍军人 常常由于耻辱而不愿在疼痛专科诊所寻求护理（例如，吸毒行为）和频繁 OAT给药访视。步行是慢性疼痛CBT的核心组成部分，并已证明有效 减轻慢性疼痛患者的疼痛。更具体地说，步行已被确定为一种低成本、高效率的方法。 已被证明可以减轻疼痛、残疾并提高个人生活质量的可获得干预措施 慢性疼痛，但尚未在参与OAT的OUD退伍军人中进行测试。 拟议的研究将确定以下步骤的可行性、可接受性和初步疗效： 改变（S2 C），一种行为疼痛治疗，包括生物心理社会疼痛教育和适应性 步行计划重要的是，S2 C将在退伍军人的OAT诊所内提供，以增加访问， 鼓励参与治疗。疼痛干扰（主要结局）使用生态瞬时 评估（EMA），其中使用移动终端对行为进行重复采样。使用EMA测量 疼痛干扰为临床测量提供了相当大的好处，包括显着减少回忆 偏置，并大大提高了测量的可靠性。将使用研究测量每日步数 提供计步器，并在一天结束时进行EMA调查。60名退伍军人将随机分配至1） S2 C或2）健康教育对照组，每组由OAT诊所每周4x 60分钟的组组成。所有 参与者将完成为期8周的EMA调查（基线1周，治疗4周，治疗后1周，3周， 6个月随访）。我们预测，研究程序将是可行的，及时随机化， 治疗组之间的保留率和EMA调查完成率相当。我们还预测， 两组都将治疗评定为满意和可信，随机分配到S2 C的退伍军人报告更多 治疗后每天的平均步数。最后，我们预测接受S2 C的退伍军人将报告较低的疼痛 干预（与健康教育）在治疗后和3个月和6个月的随访。 迫切需要可获得的，基于证据的疼痛治疗，可以整合在 VHA的专门OAT诊所和物质使用障碍诊所。这种治疗将有助于集中 暴露于慢性疼痛治疗，而不是作为慢性疼痛的CBT的替代品。迄今为止， 在接受OAT的OUD退伍军人中尚未评估干预措施，这是一个高发病率的人群， 未经治疗的慢性疼痛往往被排除在疼痛治疗研究之外。