Adapting Web-based CBT to improve adherence and outcome for individuals with opioid use disorder and chronic pain treated with opioid agonists

慢性疼痛在接受阿片类激动剂治疗（OAT; 丁丙诺啡或美沙酮），并与较差的阿片类药物使用障碍（OUD）相关 结果，包括更高的自然减员和更高的药物使用水平。慢性疼痛的治疗 维持OAT的个体是复杂的，因为慢性疼痛的存在与 精神疾病以及睡眠问题和其他问题的频率更高 可能导致不良结局的合并症。鉴于大量的个人 慢性疼痛寻求OAT，标准化，低成本，易于传播的方法 治疗患有慢性疼痛的OAT患者，如果证明 在这一人群中有效，将具有很高的公共卫生意义。 为了响应RFA-AT-19-006，我们计划开发和试点测试一个集成的，基于网络的 认知行为方法（R61阶段），然后进行随机临床试验 在大量不同的个体样本中评估其相对于标准治疗的疗效， 用丁丙诺啡或美沙酮治疗慢性疼痛（R33期）。新方案将 保留了卡罗尔博士基于计算机的认知行为治疗培训的关键组成部分 （CBT 4CBT），包括其对教学认知和行为应对技能的重视， 吸引人的方式，并专注于MAT的5A（坚持，出席，禁欲，交替 活动和信息技术支持）;它将添加来自Heiden博士的COPES的组件 （合作疼痛教育和自我管理）干预（慢性疼痛自我管理） 疼痛，通过IVR监测疼痛强度和干扰、体力活动和技能练习） 并修改现有的CBT 4CBT模块，以解决疼痛和 这一人群的药物使用，强调发展可推广的技能。在R33 阶段，我们将进行一项随机临床试验，评估CBT 4CBT-COPES在不同的 样本160名参加激动剂治疗（美沙酮或丁丙诺啡）的个体， 慢性疼痛，在一项为期3个月的随机临床试验中，随访6个月，将其与 标准治疗。主要保留结果将是对激动剂的依从性 治疗;主要疼痛结局为PROMIS 6项疼痛干预简表。

Chronic pain is common among individuals treated with opioid agonist therapies (OAT; buprenorphine or methadone) and is associated with poorer opioid use disorder (OUD) outcomes, including higher attrition and higher levels of drug use. Treatment of chronic pain in individuals who are maintained on OAT is complex, as presence of chronic pain is associated with greater frequency of psychiatric disorders as well as sleep problems and other comorbidities that can contribute to poorer outcomes. Given the large number of individuals with chronic pain seeking OAT, standardized, lower-cost, and easily disseminable approaches to treat individuals in OAT who have chronic pain are needed and, if demonstrated to be effective in this population, would have high public health significance. In response to RFA-AT-19-006, we plan to develop and pilot test an integrated, web-based cognitive behavioral approach (R61 phase), and then conduct a randomized clinical trial evaluating its efficacy relative to standard care in a large and diverse sample of individuals with chronic pain treated with buprenorphine or methadone (R33 phase). The new program will retain key components of Dr. Carroll’s computer-based training for cognitive-behavioral therapy (CBT4CBT), including its emphasis on teaching cognitive and behavioral coping skills in an engaging way and focus on the 5 A’s of MAT (Adherence, Attendance, Abstinence, Alternate Activities and Accessing support); it will add components from Dr. Heapy’s COPES (Cooperative Pain Education and Self-Management) intervention (self-management of chronic pain, with IVR monitoring of pain intensity and interference, physical activity, and skills practice) and modify existing CBT4CBT modules to address the complex interplay between pain and drug use in this population, emphasizing the development of generalizable skills. In the R33 phase, we will conduct a randomized clinical trial evaluating CBT4CBT-COPES in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or buprenorphine) who have chronic pain, in a 3-month randomized clinical trial with a 6-month follow-up, comparing it to standard treatment alone. The primary retention outcome will be adherence with agonist treatment; the primary pain outcome will be the PROMIS 6-item Pain Interference Short Form.