Development of a digital therapeutic targeting anxiety sensitivity to reduce PTSD-SUD in women presenting for emergency care after sexual assault.

开发一种针对焦虑敏感性的数字疗法，以减少性侵犯后寻求紧急护理的女性的 PTSD-SUD。

• 批准号: 10449766
• 负责人: Nicole Amai Short
• 金额: $ 15.93万
• 依托单位: UNIVERSITY OF NEVADA LAS VEGAS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10449766
• 关键词: Accident and Emergency department; Address; Adverse effects; Affect; American; Anti-Anxiety Agents; Anxiety Disorders; Arousal; Attenuated; Automobile Driving; Cannabis; Caring; Cellular Phone; Chronic Post Traumatic Stress Disorder; Clinical; Clinical Trials; Cognitive Therapy; Cohort Studies; Complement; Cues; Dangerousness; Data; Development; Disease; Distress; Ecological momentary assessment; Emergency Care; Emergency Situation; Fright; Incidence; Intervention; Intervention Studies; Knowledge; Measures; Mental Health; Mentors; Methods; Modeling; Modification; National Institute of Drug Abuse; Observational Study; Outcome; Patient Self-Report; Physiological; Post-Traumatic Stress Disorders; Pregnancy; Prevention approach; Preventive; Public Health; Randomized; Relaxation; Reporting; Research; Risk; Risk Factors; Severities; Sexually Transmitted Diseases; Site; Statistical Data Interpretation; Surveys; Survivors; Symptoms; Technology; Testing; Training; Training Programs; Trauma; Treatment Efficacy; Treatment outcome; United States; Visit; Woman; Work; Wrist; anxiety reduction; anxiety sensitivity; anxious; assault; biobehavior; cannabis craving; career; clinically significant; comorbidity; computerized; cost; craving; cue reactivity; design; digital; digital treatment; disorder prevention; efficacious treatment; efficacy evaluation; marijuana use; marijuana use disorder; modifiable risk; novel; observational cohort study; physical conditioning; post-trauma; prevent; preventive intervention; prospective; psychoeducation; psychoeducational; response; sexual assault; skills; substance use; targeted treatment; therapeutic target; treatment strategy; usability

PROJECT SUMMARY/ABSTRACT 683,000 women are sexually assaulted annually in the US, half of whom develop chronic posttraumatic stress disorder (PTSD). Women with sexual assault-related PTSD are at markedly increased risk for cannabis use disorder (CUD), a public health problem affecting 13 million Americans and contributing to the >$200 billion US annual costs of substance use. Indeed, in an observational study of 706 women sexual assault survivors, half had clinically significant PTSD and reported cannabis use. Those with comorbid PTSD-CUD have more severe presentations and worse treatment outcomes than either condition alone, underscoring the need for preventive interventions for PTSD-CUD. 100,000 women annually seek emergency care after sexual assault and are offered preventive interventions for pregnancy and sexually transmitted infections, but not the more common sequelae of PTSD-CUD. Addressing the critical unmet need for preventive interventions for PTSD-CUD after sexual assault would reduce the public health burden and personal suffering associated with these conditions. Anxiety sensitivity (AS; fear of anxious arousal) is a malleable risk factor that prospectively predicts PTSD among sexual assault survivors in pilot data, may underlie the PTSD-CUD comorbidity, and can be reduced with brief digital therapeutics that lead to reductions in PTSD and CUD. Theoretically, and in our pilot data, AS causes PTSD symptoms to be interpreted as threatening and to be avoided, leading to substance cravings and use to dampen physiological arousal measured via electrodermal activity (EDA). Specifically, cannabis is commonly used as an anxiolytic after sexual assault among those with high AS, but unfortunately can lead to the adverse effects of comorbid PTSD-CUD on symptoms and outcomes. The proposed K23 will leverage smartphones and an established research network of emergency care sites for sexual assault to provide a digital therapeutic targeting AS (based on a validated cognitive behavioral treatment) and conduct biobehavioral assessments of mechanisms underlying targeting AS to reduce PTSD-CUD. Aims are to test acceptability, initial efficacy, and mechanisms of an AS digital therapeutic to reduce PTSD-CUD compared to a relaxation control. Women presenting for emergency care after sexual assault (total N=78) will complete assessments at the emergency visit and 1 week, then will be randomized and complete their assigned interventions. Outcomes and mechanisms will be assessed by ecological momentary assessment and intervention (EMA/EMI), a wearable assessing EDA over 6 weeks, and via 6 week and 6 month self-report follow-ups. In this context, the applicant will receive training in the design and conduct of preventive multi-site emergency care-based RCTs, advanced statistical analysis for RCTs incorporating EMA, and biobehavioral assessments of mechanisms underlying PTSD-CUD prevention, setting the stage for an R01 definitive mechanistic clinical trial and launching her independent research career focused on reducing the public health burden of PTSD-CUD after sexual assault using digital therapeutics.

项目摘要/摘要 美国每年有68.3万名女性遭到性侵，其中一半人患有慢性创伤后应激障碍 精神障碍(PTSD)。患有与性侵犯相关的创伤后应激障碍的女性使用大麻的风险显著增加 失调症(CUD)，一种影响1300万美国人的公共卫生问题，为美国贡献了2000亿美元 物质使用的年度成本。事实上，在一项对706名女性性侵幸存者的观察性研究中，有一半 有临床上严重的创伤后应激障碍，并报告使用大麻。患有创伤后应激障碍的患者更严重 表现和治疗结果比单独治疗任何一种情况都要差，强调了预防的必要性 创伤后应激障碍-CUD的干预。每年有100,000名女性在性侵犯后寻求紧急护理，并提供 对怀孕和性传播感染的预防性干预，但不是更常见的后遗症 创伤后应激障碍。解决对性行为后创伤后应激障碍-CUD进行预防性干预的严重未满足需求 攻击将减轻与这些情况相关的公共卫生负担和个人痛苦。焦虑感 敏感性(AS；对焦虑性唤起的恐惧)是一个可延展的危险因素，可前瞻性地预测性行为中的创伤后应激障碍 飞行员数据中的袭击幸存者，可能是创伤后应激障碍-CUD共病的基础，并可以通过简短的数字减少 治疗导致创伤后应激障碍和CUD的减少。从理论上讲，在我们的试点数据中，AS会导致创伤后应激障碍 症状被解释为威胁性的，应该避免，导致对物质的渴望并用来抑制 通过皮肤电活动(EDA)测量生理唤醒。具体地说，大麻通常被用作 强直性脊柱炎患者性侵后的抗焦虑作用，但不幸的是， 在症状和结果上合并创伤后应激障碍。提议的K23将利用智能手机和 建立性侵犯紧急护理网站研究网络，提供数字化治疗靶向 AS(基于有效的认知行为治疗)，并进行生物行为评估 降低创伤后应激障碍的潜在靶向机制。目的是测试可接受性、初步疗效和 与放松控制相比，AS数字治疗减少PTSD-CUD的机制。女人 性侵犯后提出紧急护理(总计N=78人)将在紧急情况下完成评估 访问和1周，然后将随机完成其分配的干预措施。成果和机制 将通过生态瞬时评估和干预(EMA/EMI)进行评估，这是一种可穿戴评估EDA 超过6周，并通过6周和6个月的自我报告随访。在这方面，申请者将接受培训。 在设计和实施基于预防性多地点急救护理的RCT时，先进的统计分析 对于纳入EMA的随机对照试验，以及创伤后应激障碍-CUD预防机制的生物行为评估， 为R01最终的机械临床试验奠定基础，并开始她的独立研究生涯 重点是使用数字疗法减轻性侵犯后创伤后应激障碍-CUD的公共健康负担。