HYBRID TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL FOR PRIMARY CARE DEPRESSION SCREENING AND REFERRAL TO A REMOTE DIGITAL MENTAL HEALTH CLINIC

初级保健抑郁症筛查和转诊至远程数字心理健康诊所的混合 1 型有效性实施试验

• 批准号: 10375031
• 负责人: Nicholas Peiper
• 金额: $ 74.97万
• 依托单位: MERU HEALTH MEDICAL, P.A.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-07 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10375031
• 关键词: Administrator; Adult; Affect; Aftercare; Antidepressive Agents; Anxiety; Appointment; Attitude; Behavioral; Biofeedback; Caring; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Communication; Competence; Data; Depressed mood; Depression screen; Devices; Effectiveness; Enrollment; Ensure; Feedback; Future; Health; Health Professional; Healthcare Systems; Hybrids; Impairment; Improve Access; Individual; Intervention; Interview; Knowledge; Materials Testing; Measures; Medical; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Methods; Modality; Modeling; Motivation; Nutritional; Outcome; Participant; Patient Care; Patients; Pattern; Persons; Pharmacology; Phase; Plague; Population; Preparation; Primary Health Care; Procedures; Process; Productivity; Provider; Psychiatrist; Psychiatry; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Schedule; Severities; Site; Sleep; Small Business Innovation Research Grant; Specificity; Surveys; System; Testing; Time; Training; Transportation; United States; Work; barrier to care; base; burnout; care providers; care seeking; clinically significant; cohort; collaborative care; comorbidity; contextual factors; cost; depressive symptoms; design; digital health; digital mental health; disability; effectiveness implementation trial; effectiveness testing; experience; heart rate variability; help-seeking behavior; implementation determinants; implementation facilitators; improved; information gathering; intervention program; mindfulness meditation; mobile application; peer; phase 2 study; post intervention; primary care setting; primary outcome; process evaluation; programs; psychologic; recruit; research clinical testing; response; satisfaction; screening; side effect; single episode major depressive disorder; social stigma; standard care; treatment as usual; treatment program

ABSTRACT The global burden of depression is staggering: Affecting an estimated 7 to 10% of the adult U.S. population in any given year, depression’s high rates of comorbid conditions and association with impaired functioning and disability costs the U.S. approximately $200 billion per year. Issues continue to plague screening, recognition, and treatment for depression in primary care settings. Patients with depression are recognized as such, less than half of the time in the U.S, with 49.2% sensitivity and 81.1% specificity for accurately identifying patients having a current major depressive episode. Treatment for depression usually begins with primary care providers prescribing antidepressants and use of collaborative care models, however, patients experience many barriers to these treatments such as high costs, embarrassment in seeking help, and long waits for appointments. These treatments have also been shown to have only a short-term effect, and patients continue seeking treatment without finding an accessible and effective solution to alleviate their depressive symptoms. Meru Health Medical, P.A. developed a complete and clinically proven treatment program for depression, anxiety, and burnout with long-lasting outcomes. The Meru Health Program (MHP) is a 12-week, mobile app- based online digital mental health clinic overseen by a licensed clinical therapist and a psychiatrist. The delivery of the MHP seeks to overcome many of the barriers that can hinder the receipt of mental health services such as improved access and less stigma. This SBIR Direct-to-Phase II application is aimed to conduct a multi-site Hybrid Type 1 Randomized Control Trial (RCT) of the MHP among adults who screen positive for depression in primary care to prepare for the program’s rapid dissemination. This application proposes a proof-of-concept study to develop and optimize the study materials, test the screening, referral, and study enrollment procedures in preparation for a 300-patient multisite RCT. Following, a multistakeholder process evaluation of the delivery of the MHP intervention will be conducted to guide the set-up of subsequent studies and to better understand contextual factors for implementation. The study design allows simultaneous testing of the effectiveness of the clinical intervention on relevant outcomes while observing and gathering information on implementation which is requisite for the program’s rapid dissemination. The unique benefit of the MHP is in its discreet administration to patients with the treatment modalities and approaches utilized in the program, validated by high quality studies showing significant proof of efficiency. Meru Health Medical, P.A. is committed to cutting-edge research conducted with integrity as a way to continuously improve the MHP. This application will establish the feasibility of referral to the MHP via direct screening in a primary care setting, benefiting the high percentage of U.S. adults turning to primary care healthcare professionals who seek a long-lasting treatment method for depression.

摘要 抑郁症的全球负担是惊人的：影响估计7%至10%的美国成年人口， 在任何一年，抑郁症的高共病率和与功能受损的关联， 残疾每年花费美国大约2000亿美元。问题继续困扰着筛查，识别， 以及在初级保健机构中治疗抑郁症。抑郁症患者被认为是这样的， 在美国超过一半的时间，准确识别患者的灵敏度为49.2%，特异性为81.1% 正在经历重度抑郁发作抑郁症的治疗通常从初级保健提供者开始 然而，处方抗抑郁药和使用协作护理模式，患者会遇到许多障碍， 对这些治疗，如高成本，寻求帮助的尴尬，和漫长的等待预约。这些 治疗也被证明只有短期效果，患者继续寻求治疗 没有找到一个方便和有效的解决办法来减轻他们的抑郁症状。 Meru Health Medical，P.A.开发了一套完整的、经过临床验证的抑郁症治疗方案， 焦虑和倦怠的长期后果。梅鲁健康计划（MHP）是一个为期12周的移动的应用程序- 基于在线数字心理健康诊所，由持牌临床治疗师和精神病学家监督。了供货备货 MHP旨在克服许多可能阻碍接受心理健康服务的障碍， 更容易获得和更少的耻辱。此SBIR直接到第二阶段应用旨在进行多站点 在抑郁症筛查阳性的成年人中进行的MHP混合1型随机对照试验（RCT） 为该计划的快速传播做好准备。本申请提出了一种概念验证 研究，以开发和优化研究材料，测试筛选，转诊和研究入组程序 准备一项300名患者的多中心随机对照试验。随后，多方利益攸关方对交付情况进行了评估， 将进行MHP干预，以指导后续研究的设置，并更好地了解 实施的背景因素。 研究设计允许同时测试临床干预对相关患者的有效性。 同时观察和收集有关执行情况的信息，这是该方案迅速实施的必要条件。 传播。MHP的独特优势在于其对患者的谨慎管理 程序中使用的模式和方法，通过高质量的研究进行验证，显示出重要的证据， 效率Meru Health Medical，P.A.致力于以诚信进行尖端研究， 不断完善MHP。此申请将确定通过直接向MHP转介的可行性 在初级保健环境中进行筛查，使高比例的美国成年人转向初级保健 寻求持久治疗抑郁症方法的医疗保健专业人员。