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: 10417745
• 负责人: Allison G Harvey
• 金额: $ 10.62万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10417745
• 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 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.

！ 抽象的 推出针对严重精神疾病（SMI）的循证治疗（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，导致两者之间缺乏“契合度” 我们建议评估是否采用特定的治疗方法来改善环境契合度。 改善代表这一挑战的环境——社区心理健康中心 (CMHC) 的结果。 按照实验治疗方法，SMI 的目标是睡眠和昼夜节律功能障碍。 睡眠和昼夜节律失调会破坏调节、认知功能和身体健康，预测 症状的发作和恶化，即使经过基于证据的 SMI 治疗，也常常是慢性的。 治疗研究以疾病为重点——他们治疗了特定的睡眠问题（例如失眠） 然而，现实生活中的睡眠和昼夜节律问题并不是那么简单。 因此，我们开发了针对睡眠和昼夜节律的跨诊断干预。 Dysfunction (TranS-C) 用于治疗 SMI 中出现的各种睡眠和昼夜节律问题。 在 NIMH 的支持下，包括对 CMHC 的一项研究，我们确定 TranS-C 与目标存在差距。 仍然： 1) 到目前为止，TranS-C 提供者已由大学聘用、培训和监督。 将确定 CMHC 内的提供商是否可以有效地提供 TranS-C 2) 我们将测试一个版本。 TranS-C 已进行了调整，以提高拟合度并解决扩展 TranS-C 的潜在障碍。 严格的适应过程使用了理论、数据和利益相关者的意见 3) 我们将研究临时适应。 由 TranS-C 的提供商制定。 4) 我们包括两个阶段，即实施阶段（2 年）和实施阶段。 维持阶段（1 年）。后者响应研究 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 诊所站点将被随机分为标准或改编 TranS-C 然后，在每个 CMHC 站点内， 患者将被随机分配接受立即 TranS-C 治疗或接受常规治疗，然后接受延迟治疗 (UC-DT)。 共有 96 名提供者和 576 名患者将参与治疗前、治疗中和治疗后的评估。 加州大学伯克利分校将在 6 个月的后续行动中协调研究、促进实施、收集数据。 已建立的 CMHC 网络内的提供者将实施 TranS-C，以确认两者。 与 UC-DT 相比，标准与适应 TranS-C 可以改善睡眠和昼夜节律功能，并减少 SA2 是为了评估功能障碍和以疾病为中心的精神症状是否适合 CMHC。 标准与改编的 TranS-C 的上下文将检查是否更好的拟合调解了两者之间的关系。 这项研究将确定睡眠和昼夜节律问题是否可以得到解决。 在 CMHC 设置中的 SMI 中有效解决，测试 TranS-C 的两种变体，每种变体都有独特的 优势并关注社区提供者和典型社区患者。