A transdiagnostic sleep and circadian treatment to improve community SMI outcomes

 描述(由申请人提供)：尽管治疗取得了进步，但严重的精神疾病(SMI)仍然很常见、慢性和难以治疗。SMI的定义是至少有一种精神障碍持续12个月，并导致实质性的生活干扰。睡眠和昼夜节律功能障碍是SMI最显著的相关因素之一，但人们对SMI的研究最少，反映了SMI患者经历的睡眠问题的复杂性。在SMI中，睡眠和昼夜节律障碍破坏调节、认知功能和身体健康，预测症状的开始和恶化，即使采用循证SMI治疗，也往往是慢性的。以前的治疗研究一直是以障碍为重点的--他们在特定的诊断组(例如抑郁症)中治疗特定的睡眠问题(例如失眠)。然而，现实生活中的睡眠和昼夜节律问题的分类并不那么整齐，特别是在SMI中，失眠的特征与过度睡眠、睡眠相延迟和睡眠-醒来时间不规律重叠。因此，我们的目标是测试这一假设，即对睡眠和昼夜节律障碍(TRANS-C)的跨诊断干预将改善功能障碍、以障碍为重点的症状以及睡眠和昼夜功能。我们将在DSM诊断和常见的睡眠和昼夜节律问题上招募参与者。在以研究为基础的提供者的研究环境中，TRANS-C的元素在SMI中是有效的。下一步是在社区环境中与基于社区的提供商一起测试tran-C。因此，我们建议在阿拉米达县行为保健服务(ACBHCS)内进行一项“真实世界中的疗效”随机对照试验，即阿拉米达县的CMHC。阿拉米达县是湾区种族最多元化的县。我们将招募120名在ACBHCS中被诊断为患有SMI和睡眠和昼夜节律障碍的成年人。个人将被随机分配到Trans-C组(n=60)或6个月的常规护理，然后再用Trans-C延迟治疗(UC-DT；n=60)。TRANS-C是模块化的，通过八个50分钟的每周单独课程提供。所有参与者将在治疗前、治疗后立即和6个月后再次接受评估。中介分析将检查睡眠和昼夜节律功能的改善是否中介主要结果的改善。适度分析将检查干预效果是否与先前报道的危险因素有关，包括人口统计学、症状严重程度、药物、治疗地点和季节以及精神和内科合并症。该应用程序响应了NIMH的优先事项，重点是在社区中实施有效的服务，以及个性化、通用化和不受诊断标准限制的治疗。RDoC是通过招募诊断参与者并广泛定义睡眠和昼夜节律障碍来解决的。来自觉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衡量标准。我们的长期目标是建立跨C病毒广泛传播的潜力。

 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.