A transdiagnostic sleep and circadian treatment to improve community SMI outcomes

 描述（由申请人提供）：尽管治疗取得了进展，但严重精神疾病（SMI）仍然是常见的、慢性的和难以治疗的。严重精神疾病的定义是至少有一种精神障碍持续12个月，并导致严重的生活干扰。睡眠和昼夜节律功能障碍是SMI最突出的相关因素之一，但对反映SMI患者睡眠问题复杂性的研究很少。在SMI中，睡眠和昼夜节律功能障碍破坏情感调节，认知功能和身体健康，预测症状的发作和恶化，并且即使使用循证SMI治疗也通常是慢性的。以前的治疗研究一直是以疾病为重点的-他们治疗了一个特定的睡眠问题（例如，失眠）在特定诊断组（例如，抑郁症）。然而，真实的生活中的睡眠和昼夜节律问题并没有如此整齐地分类，特别是在SMI中，失眠与嗜睡、睡眠期延迟和不规则的睡眠-觉醒时间表重叠。因此，我们的目标是测试这样的假设，即睡眠和昼夜节律功能障碍的跨诊断干预（trans-C）将改善功能障碍、以障碍为重点的症状以及睡眠和昼夜节律功能。我们将招募不同DSM诊断以及常见睡眠和昼夜节律问题的参与者。TransS-C的元素是有效的整个SMI的研究设置与研究为基础的供应商。下一步是在社区设置中与基于社区的提供商一起测试TransS-C。因此，我们建议在阿拉米达县的CMHC阿拉米达县行为卫生保健服务（ACBHCS）内进行一项“在真实的世界中的疗效”随机对照试验。阿拉米达县是海湾地区种族最多样化的县。我们将招募120名被诊断患有SMI和ACBHCS内的睡眠和昼夜节律功能障碍的成年人。个体将被随机分配至TranS-C（n = 60）或6个月的住院治疗，随后接受TranS-C延迟治疗（UC-DT; n = 60）。TransS-C是模块化的，并在八个50分钟，每周，个别会议交付。所有受试者将在治疗前、治疗后立即和6个月后再次接受评估。中介分析将检查改善的睡眠和昼夜节律功能是否介导主要结局的改善。适度分析将检查干预疗效是否与先前报告的风险因素相关，包括人口统计学、症状严重程度、药物、治疗部位和季节以及精神和医学合并症。该应用程序响应NIMH的优先事项，重点是在社区实施有效的服务以及个性化，可推广且不受诊断标准限制的治疗。RDoC通过招募不同诊断的参与者并广泛定义睡眠和昼夜节律功能障碍来解决。来自唤醒和调节系统领域的“睡眠-觉醒”和“生物节律”结构是干预目标和结果测量。我们的长期目标是建立Trans-C广泛传播的潜力。

 DESCRIPTION (provided by applicant): Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, we aim to test the hypothesis that a Trans diagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder- focused symptoms and sleep and circadian functioning. We will recruit participants across DSM diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, we propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the CMHC for Alameda County. Alameda County is the most ethnically diverse county in the Bay Area. We will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC- DT; n = 60). TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment and again 6 months later. Mediation analyses will examine whether improved sleep and circadian rhythm functioning mediate improvements in primary outcomes. Moderation analyses will examine if intervention efficacy is related to previously reported risk factors including demographics, symptom severity, medications, site, and season of treatment as well as psychiatric and medical comorbidity. This application is responsive to NIMH priorities focusing on implementing effective services in the community as well as treatments that are personalized, generalizable and not constrained by diagnostic criteria. RDoC is addressed by recruiting participants across diagnoses and defining sleep and circadian dysfunction broadly. The 'sleep-wake' and 'biological rhythms' constructs from the Arousal and Modulatory Systems domain are intervention targets and outcome measures. Our long-term objective is to establish the potential for widespread dissemination of TranS-C.