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

好了！ 摘要 严重精神疾病(SMI)循证治疗(EBTS)推广的一个障碍是 实现的上下文通常与原始测试上下文不同，从而导致 布景和EBT。我们建议评估是否采用特定的治疗方法来改善背景匹配 改善这一挑战的典型环境--社区精神卫生中心(CMHC)的结果。 遵循实验治疗学的方法，目标是睡眠和昼夜节律障碍。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 症状的出现和恶化往往是慢性的，即使采用循证的SMI治疗也是如此。之前 治疗研究一直是以障碍为重点的--他们治疗了一种特定的睡眠问题(例如，失眠)。 特定的诊断组(例如，抑郁症)。然而，现实生活中的睡眠和昼夜节律问题却并非如此。 分类，特别是在SMI中。因此，我们开发了睡眠和昼夜节律的跨诊断干预 功能障碍(反式-C)，用于治疗SMI患者经历的一系列睡眠和昼夜节律问题。 在NIMH的支持下，包括在CMHC的一项研究中，我们确定了反式C与靶点的作用。然而，差距仍然存在 保留：1)到目前为止，反式-C提供者都是由大学雇用、培训和监督的。我们 将决定是否可以由CMHC内的供应商有效地提供TRAN-C。2)我们将测试一个版本的 已经被修改以提高适合性并解决扩展反式C的潜在障碍的反式-C。这个 严格的适应过程使用了理论、数据和利益攸关方的投入。3)我们将研究临时适应 由tran-C的供应商制作。4)我们包括两个阶段，即实施阶段(两年)和 维持阶段(1年)。后者响应了研究EBTS可持续性的迫切呼吁。 在复制有效计划(REP)框架的指导下，在这项为期4年的混合型研究中，8个CMHC 诊所地点将随机分为标准或适应的Trans-C。然后，在每个CMHC站点内， 患者将被随机分为即刻TRANS-C组或常规护理后延迟治疗组(UC-DT)。一个 共有96名提供者和576名患者将参与其中。患者将在治疗前、治疗中和治疗后进行评估。 术后6个月随访。加州大学伯克利分校将协调研究，促进实施，收集数据 等。已建立的CMHC网络内的提供商将实施TransC。SA1是确认双方 与UC-DT相比，标准与适应反式C相比，改善睡眠和昼夜节律功能并减少 功能障碍和以精神障碍为中心的症状。SA2是为了评估契合度，到CMHC 标准版与改编版TRANS-C的上下文。SA3将研究更好的契合度是否在 治疗情况和患者转归。这项研究将确定睡眠和昼夜节律问题是否会 在CMHC设置的SMI中有效解决，测试两种不同的TransC变体，每种变体都具有 优势和重点放在社区提供者和典型的社区患者。

! 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.