Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health.

实施和维持跨诊断睡眠和昼夜节律治疗，以改善社区心理健康中严重精神疾病的结果。

• 批准号: 10492899
• 负责人: Allison G Harvey
• 金额: $ 4.3万
• 依托单位: UNIVERSITY OF CALIFORNIA BERKELEY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-05 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10492899
• 关键词: Address; Affect; Aftercare; Chronic; Circadian Dysregulation; Clinic; Code; Communities; Community Mental Health Centers; Community Networks; Data; Diagnostic; Disease; Dose; Elements; Evidence based treatment; Functional disorder; Hybrids; Hypersomnias; Individual; Intervention; Investigational Therapies; Knowledge; Life; Measures; Mediating; Medical; Mental Depression; Mental Health; Methods; Modification; National Institute of Mental Health; Outcome; Participant; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; PhenX Toolkit; Process; Provider; Public Health; Randomized; Regulation; Replicating Effective Programs; Research; Risk Factors; Schedule; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Structure; Supervision; Symptoms; Testing; TimeLine; Training; Universities; Variant; bench to bedside; circadian; cognitive function; comorbidity; demographics; evidence base; experience; follow-up; functional disability; implementation context; implementation facilitation; implementation outcomes; implementation process; implementation strategy; improved; improved functioning; improved outcome; intervention effect; physical conditioning; psychiatric symptom; reduce symptoms; severe mental illness; standard care; theories; treatment as usual; treatment comparison

! Abstract An obstacle to the roll-out of evidence-based treatments (EBTs) for severe mental illness (SMI) is that the context for the implementation typically differs from the original testing context causing a lack of “fit” between the setting and the EBT. We propose to evaluate if adapting a specific treatment to improve the contextual fit improves outcomes in a setting that typifies this challenge—community mental health centers (CMHCs). Following the Experimental Therapeutics Approach, the target is sleep and circadian dysfunction. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts the 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. Hence, we developed the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to treat a wide range of sleep and circadian problems experienced in SMI. With NIMH support, including a study in CMHCs, we established that TranS-C engages the target. Yet gaps remain: 1) Thus far, the TranS-C providers have been employed, trained and supervised by the university. We will determine if TranS-C can be effectively delivered by providers within CMHCs. 2) We will test a version of TranS-C that has been adapted to improve the fit and to address potential barriers to scaling TranS-C. The rigorous adaptation process used theory, data and stakeholder inputs. 3) We will study ad hoc adaptations made by providers to TranS-C. 4) We include two stages; namely, the Implementation Phase (2 years) and the Sustainment Phase (1 year). The latter responds to urgent calls to study the sustainability of EBTs. Guided by the Replicating Effective Programs (REP) framework, in this Hybrid Type 1, 4-year study, 8 CMHC clinic sites will be cluster randomized to either Standard or Adapted TranS-C. Then, within each CMHC site, patients will be randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). A total of 96 providers and 576 patients will participate. Patients will be assessed pre, mid and post-treatment and at 6 months follow-up. UC Berkeley will co-ordinate the research, facilitate implementation, collect data etc. Providers within an established network of CMHCs will implement TranS-C. SA1 is to confirm that both Standard vs. Adapted TranS-C, compared to UC-DT, improve sleep and circadian functioning and reduce functional impairment and disorder-focused psychiatric symptoms. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C. SA3 will examine if better fit mediates the relationship between treatment condition and patient outcome. This research will determine if sleep and circadian problems can be effectively addressed in SMI in CMHC settings, test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.

! 摘要 严重精神疾病（SMI）循证治疗（EBT）的一个障碍是， 实现的上下文通常与原始测试上下文不同， 设置和EBT。我们建议评估是否采用特定的治疗方法来改善情境适应性 改善结果在一个设置，代表这一挑战-社区精神卫生中心（CMHC）。 根据实验治疗方法，目标是睡眠和昼夜节律功能障碍。在SMI， 睡眠和昼夜节律紊乱破坏情感调节、认知功能和身体健康， 症状的发作和恶化，即使采用循证SMI治疗，也常常是慢性的。之前 治疗研究是以疾病为中心的-它们治疗了特定的睡眠问题（例如，失眠）， 特定的诊断组（例如，抑郁症）。然而，真实的生活中的睡眠和昼夜节律问题并不那么整齐 分类，特别是在SMI。因此，我们开发了睡眠和昼夜节律的跨诊断干预 功能障碍（TransS-C）治疗SMI中出现的各种睡眠和昼夜节律问题。 在NIMH的支持下，包括在CMHC中的研究，我们确定了TransS-C与目标接合。然而， 1）到目前为止，TransS-C供应商一直由大学雇用，培训和监督。我们 将决定CMHC内的供应商是否可以有效地提供TransS-C。2)我们将测试 TransS-C已经过调整，以改善拟合并解决扩展TransS-C的潜在障碍。的 严格的适应进程使用理论、数据和利害关系方的投入。3)我们将研究特别改编 由提供商向Trans-C提供。4)我们包括两个阶段，即实施阶段（2年）和 维持阶段（1年）。后者响应了研究EBT可持续性的紧急呼吁。 在复制有效计划（REP）框架的指导下，在这项为期4年的混合1型研究中，8 CMHC 临床研究中心将被随机分组至标准或适应性TransS-C。然后，在每个CMHC站点内， 患者将被随机分配至立即Trans-C或住院治疗后延迟治疗（UC-DT）。一 共有96名医疗服务提供者和576名患者参加。将在治疗前、治疗中和治疗后对患者进行评估 和6个月随访时。加州大学伯克利分校将协调研究、促进实施、收集数据 等CMHC已建立网络内的供应商将实施TransS-C。SA 1是为了确认 与UC-DT相比，标准与适应性TransS-C可改善睡眠和昼夜节律功能， 功能障碍和以障碍为中心的精神症状。SA 2用于评估CMHC的拟合度 标准与适配的TransS-C。SA 3将检查更好的拟合是否介导了 治疗条件和患者结局。这项研究将确定睡眠和昼夜节律问题是否可以 在CMHC设置中的SMI中有效解决，测试两种具有独特 优势和重点是社区提供者和典型的社区患者。