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.

抽象的 全球抑郁症负担令人震惊：估计影响 7% 至 10% 的美国成年人 任何一年，抑郁症的合并症发生率都很高，并且与功能障碍和功能障碍有关 残疾问题每年给美国造成约 2000 亿美元的损失，这一问题继续困扰着筛查、识别、治疗和治疗。 抑郁症患者在初级保健机构中的治疗也得到了较少的认可。 超过美国一半的时间，准确识别患者的敏感性为 49.2%，特异性为 81.1% 当前患有严重抑郁症的患者通常从初级保健提供者开始治疗抑郁症。 然而，在开抗抑郁药和使用协作护理模式时，患者会遇到许多障碍 这些治疗方法包括费用高、寻求帮助时的尴尬以及预约等待时间长等。 治疗也被证明仅具有短期效果，患者继续寻求治疗 没有找到一种可行且有效的解决方案来缓解他们的抑郁症状。 Meru Health Medical, P.A. 开发了一套完整且经过临床验证的抑郁症治疗方案， Meru 健康计划 (MHP) 是一个为期 12 周的移动应用程序。 由持证临床治疗师和精神病患者监督的在线数字心理健康诊所。 MHP 致力于克服许多可能阻碍接受精神卫生服务的障碍，例如 SBIR Direct-to-Phase II 申请旨在改善准入并减少耻辱。 在抑郁症筛查呈阳性的成年人中进行 MHP 的混合 1 型随机对照试验 (RCT) 初级保健，为该计划的快速传播做好准备。该应用程序提出了概念验证。 研究开发和优化学习材料，测试筛选、转介和学习注册程序 为 300 名患者的多中心随机对照试验做准备，随后对交付进行多利益相关者过程评估。 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 成果，同时观察和收集实施信息，这是该计划快速实施所必需的 MHP 的独特优势在于其对接受治疗的患者进行谨慎给药。 该计划中使用的模式和方法，经过高质量研究的验证，显示出重要的证据 Meru Health Medical, P.A. 致力于以诚信的方式进行尖端研究。 不断改进 MHP。该申请将建立通过直接转介至 MHP 的可行性。 在初级保健机构进行筛查，使大部分转向初级保健的美国成年人受益 寻求持久治疗抑郁症方法的医疗保健专业人员。