Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals with OUD

新型远程医疗延长暴露疗法可治疗 OUD 患者的 PTSD

• 批准号: 10736847
• 负责人: Kelly R. Peck
• 金额: $ 69.69万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10736847
• 关键词: Address; Adherence; Adult; Agonist; Biochemical; Buprenorphine; COVID-19 pandemic; Cognitive Therapy; Country; Data; Dropout; Drug usage; Enrollment; Evaluation; General Population; Grain; Health Personnel; Health Services Accessibility; Individual; Intervention; Investigation; Knowledge; Measures; Mental Health; Methadone; Modality; Opioid; Outcome; Overdose; Participant; Patient Self-Report; Patients; Persons; Pilot Projects; Population; Post-Traumatic Stress Disorders; Poverty; Protocols documentation; Questionnaires; Randomized; Reporting; Research; Risk; Rural; Sampling; Severities; Substance Use Disorder; Symptoms; Telemedicine; Testing; Transportation; Trauma; Treatment outcome; Urine; Visit; Vulnerable Populations; clinical practice; clinically relevant; craving; digital delivery; efficacy evaluation; evidence base; experience; financial incentive; health service use; illicit drug use; illicit opioid; improved; innovation; medication for opioid use disorder; novel; opioid overdose; opioid use; opioid use disorder; physical conditioning; reduce symptoms; rural underserved; satisfaction; social stigma; substance use; trauma exposure; treatment as usual; underserved community

PROJECT ABSTRACT Nearly 90% of individuals with OUD report lifetime trauma exposure and 33% meet criteria for PTSD. Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance. We recently demonstrated the initial feasibility of a novel PE protocol for improving therapy attendance and PTSD symptoms among individuals maintained on MOUD. Participants were randomly assigned to: (a) Treatment as usual (TAU) (b) Prolonged Exposure therapy (PE) or (c) PE with attendance contingent financial incentives (PE+). Our results demonstrated the initial efficacy of PE+, as PE+ participants attended significantly more therapy sessions than PE participants and experienced significant improvements in PTSD symptoms. Our findings also suggest that, rather than undermining patients’ stability with illicit drug use, PE may be associated with less illicit substance use than SUD treatment alone. In the proposed research, we seek to: a) conduct a more definitive evaluation of this novel PE intervention, b) utilize a novel telemedicine platform to reach underserved patients, and c) further investigate this promising initial data suggesting that PE therapy may also be associated with improvements in illicit drug use. Primary Aim: To evaluate the efficacy of a novel telemedicine-delivered PE protocol for improving therapy attendance and PTSD symptoms. We will conduct a parallel three-group RCT among 135 adults with PTSD who are maintained on MOUD (45 TAU, 45 PE, 45 PE+). All study visits will be conducted via telemedicine and attendance-contingent financial incentives will be delivered digitally. We hypothesize that participants assigned to PE+ will demonstrate greater PE session attendance and decreases in PTSD severity relative to those assigned to PE or TAU. Secondary Aims: (1) We will utilize rigorous and fine-grained assessment strategies to evaluate whether individuals receiving PE may actually experience reductions in their illicit opioid and other drug use. (2) We will conduct the first characterization of telemedicine-delivered PE acceptability and explore their association with PE treatment retention and PTSD symptom reduction. This study represents the first effort to examine the efficacy of PE delivered via telemedicine to individuals with OUD, and our investigative team is uniquely poised to disseminate our findings to improve clinical practice in real-world settings throughout the country.

项目摘要 OUD的患者中，近90％的人报告了终生创伤，33％的人符合PTSD的标准。 同时发生的PTSD和OUD患者的药物使用和精神的风险明显更大 健康结果与单独使用Oud的结果​​。尽管长期暴露（PE）治疗是一线治疗 对于PTSD而言，其效率通常会因出勤率较差而削弱。我们最近证明了初始 新颖的PE协议可行的可行性，用于提高个人的治疗出勤率和PTSD符号 维持在moud上。参与者被随机分配给：（a）照常治疗（tau）（b）延长 曝光疗法（PE）或（c）PE带有出勤情况或有经济激励措施（PE+）。我们的结果证明了 PE+的初始效率，因为PE+参与者参加的治疗时间明显超过PE参与者 并在PTSD症状方面取得了重大改善。我们的发现还表明，而不是 破坏患者使用非法吸毒的稳定性，PE可能与SUD相比，非法药物使用量较少 仅治疗。 在拟议的研究中，我们寻求：a）对这项新的PE进行更确定的评估 干预，b）利用一个新型的远程医疗平台来吸引服务不足的患者，c）进一步研究 有希望的初始数据表明，PE治疗也可能与非法药物使用的改善有关。 主要目的：评估一种新型远程医疗PE方案的效率，以改善治疗 出席和PTSD症状。我们将在具有PTSD的135名成年人中进行平行的三组RCT 维持在MOUD上（45 tau，45 pe，45 pe+）。所有研究访问将通过远程医疗和 出勤权的财务激励措施将以数字方式交付。我们假设参与者分配了 PE+将证明相对于PTSD的PE会议的出现更大，而PTSD的严重程度相对于那些 分配给PE或TAU。次要目的：（1）我们将利用严格且细粒度的评估策略来 评估接收体育的个人是否实际上可能会减少其非法阿片类药物和其他药物 使用。 （2）我们将对远程医疗延迟的PE可接受性进行首次表征，并探索其 与PE治疗保留和PTSD症状减轻相关。 这项研究代表了检查通过远程医疗传递给个体的PE效率的首次努力 有了OUD，我们的调查团队被中毒，以传播我们的发现以改善临床实践 在全国各地的现实环境中。