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 近90%的OUD患者报告终身创伤暴露，33%符合PTSD标准。 同时患有PTSD和OUD的患者在不良物质使用和精神障碍方面的风险明显更大。 与单纯OUD患者的健康结果相比。虽然延长暴露（PE）治疗是一线治疗， 对于创伤后应激障碍，其疗效通常因出勤率低而受到影响。我们最近展示了最初的 一种新的PE方案改善个体治疗出勤率和PTSD症状的可行性 保持在MOUD上。受试者被随机分配：（a）常规治疗（TAU）（B）延长 暴露疗法（PE）或（c）PE与出勤或有经济奖励（PE+）。我们的研究结果表明 PE+的初始疗效，因为PE+参与者参加的治疗次数显著多于PE参与者 创伤后应激障碍症状有了显著改善我们的研究结果还表明，而不是 破坏患者使用非法药物的稳定性，PE可能与比SUD更少的非法物质使用相关 单独治疗。 在拟议的研究中，我们寻求：a）对这种新型PE进行更明确的评价 干预，B）利用新型远程医疗平台接触服务不足的患者，以及c）进一步调查这一点 令人鼓舞的初步数据表明，体育治疗也可能与非法药物使用的改善有关。 主要目的：评价一种新型远程医疗PE方案在改善治疗方面的有效性 创伤后应激障碍症状。我们将在135名患有PTSD的成年人中进行一项平行的三组RCT， 在MOUD上维护（45 TAU，45 PE，45 PE+）。所有研究访视将通过远程医疗进行， 将以数字方式提供视出勤情况而定的财政奖励。我们假设参与者被分配了 PE+将表现出更高的PE会议出席率和PTSD严重程度的降低，相对于那些 分配到PE或TAU。次要目标：（1）我们将利用严格和细粒度的评估策略， 评估接受PE治疗的个体是否实际上减少了他们的非法阿片类药物和其他药物 使用. (2)我们将进行远程医疗提供的PE可接受性的第一次表征，并探讨其 与PE治疗保留和PTSD症状减轻相关。 这项研究代表了第一次努力，以检查通过远程医疗提供给个人的PE的疗效 与OUD合作，我们的调查团队将独一无二地传播我们的发现，以改善临床实践 在全国各地的真实世界中。