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

与平民人口相比，退伍军人的严重慢性疼痛和 阿片使用障碍(OUD)。OUD患者的慢性疼痛患病率仍然很高，尽管 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已转向 促进非药物方法治疗慢性疼痛；然而，患有OUD的个人通常 被排除在疼痛治疗临床试验之外。在慢性疼痛和接受燕麦片治疗的患者中， 最常见的疼痛应对策略是祈祷、非处方药和阿片类药物。 药物治疗。迫切需要为慢性疼痛开发基于证据的疼痛治疗方法，这种疗法可以 被整合到有慢性疼痛和OUD的退伍军人燕麦片中。 慢性疼痛的非药物治疗的金标准是认知行为疗法(Cbt)。 治疗慢性疼痛。尽管对非药物治疗疼痛有良好的看法，但许多燕麦片诊所缺乏 有足够的人员配置、培训和资源用于密集疼痛治疗，如CBT。此外，退伍军人 经常因耻辱(例如，寻求毒品的行为)和频繁的疼痛专科诊所而犹豫寻求治疗 燕麦剂量访问。步行是CBT治疗慢性疼痛的核心组成部分，已经证明是有效的 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、高度 可获得的干预已被证明可以减少疼痛、残疾并提高个人的生活质量 患有慢性疼痛，但尚未在服用燕麦片的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、可接受性和初步效果 改变(S2C)，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，S2C将在退伍军人的燕麦片诊所内提供，以增加访问和 鼓励参与治疗。使用生态瞬间收集的疼痛干预(主要结果) 评估(EMA)，使用移动设备重复对行为进行采样。EMA在计量中的应用 疼痛干预为临床测量提供了相当大的好处，包括显著减少回忆 偏差，大大提高了测量的可靠性。每天的步数将通过一项研究来衡量 提供计步器，并在当天结束时进行EMA调查。60名退伍军人将被随机分配到1) S2C或2)健康教育对照，每组由燕麦诊所每周4x60分钟的小组组成。全 参与者将完成为期8周的EMA调查(1周基线，4周治疗，1周后，3- 6个月随访)。我们预测，通过及时的随机分组，研究程序将是可行的， 治疗组之间可比较的保留率和EMA调查完成率。我们还预测，退伍军人在 两组都将治疗评为令人满意和可信，退伍军人随机到S2C报告的比例更高 治疗后平均每天步行数。最后，我们预测接受S2C的退伍军人将报告较低的疼痛 在治疗后、3个月和6个月随访时进行干预(与健康教育相比)。 迫切需要可获得的、以证据为基础的疼痛治疗，这种治疗可以整合到 VHA的燕麦专科诊所和物质使用障碍诊所。这项治疗将有助于集中 接受慢性疼痛治疗，而不是作为慢性疼痛CBT的替代品。到目前为止，一次散步 在接受燕麦片治疗的退伍军人中，干预措施尚未得到评估，这是一个发病率较高的人群 未经治疗的慢性疼痛，通常被排除在疼痛治疗研究之外。

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.