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: 9805309
• 负责人: Allison G Harvey
• 金额: $ 78.41万
• 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/9805309
• 关键词: Address; Affect; Aftercare; Chronic; Circadian Dysregulation; Clinic; Code; Communities; Community Mental Health Centers; Community Networks; Comorbidity; 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; Process; Provider; Public Health; Randomized; Regulation; 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; demographics; evidence base; experience; follow-up; functional disability; implementation strategy; improved; improved functioning; improved outcome; intervention effect; physical conditioning; programs; psychiatric symptom; reduce symptoms; severe mental illness; standard care; theories; treatment as usual; Address; Affect; Aftercare; Chronic; Circadian Dysregulation; Clinic; Code; Communities; Community Mental Health Centers; Community Networks; Comorbidity; 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; Process; Provider; Public Health; Randomized; Regulation; 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; demographics; evidence base; experience; follow-up; functional disability; implementation strategy; improved; improved functioning; improved outcome; intervention effect; physical conditioning; programs; psychiatric symptom; reduce symptoms; severe mental illness; standard care; theories; treatment as usual

! 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.

呢 抽象的 推出基于证据的治疗（EBT）严重精神疾病（SMI）的障碍是 实施的上下文通常与原始测试上下文不同，导致缺乏“适合” 设置和EBT。我们建议评估是否适应特定处理以改善上下文拟合 在代表这一挑战的环境中，改善结果 - 社区心理健康中心（CMHC）。 遵循实验治疗方法，目标是睡眠和昼夜节律功能障碍。在smi， 睡眠和昼夜节律障碍会影响调节，认知功能和身体健康，预测 症状的发作和担心，即使经证据基于证据的SMI治疗也经常是慢性的。事先的 治疗研究一直以障碍为中心 - 他们已经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）。但是，现实生活中的睡眠和昼夜节律的问题不是那么整洁 分类，特别是在SMI中。因此，我们开发了用于睡眠和昼夜节律的经诊断干预措施 功能障碍（Trans-C）治疗SMI中遇到的广泛的睡眠和昼夜节律问题。 在NIMH的支持下，包括对CMHC的研究，我们确定了Trans-C参与目标。但是空白 剩下：1）远处，trans-c提供者已经受到大学的雇用，培训和监督。我们 将确定CMHC中提供商是否可以有效地交付Trans-C。 2）我们将测试一个版本 trans-c已适应改善拟合度并解决缩放trans-c的潜在障碍。这 严格的适应过程使用了理论，数据和利益相关者的输入。 3）我们将研究临时适应 由提供者到Trans-C。 4）我们包括两个阶段；也就是说，实施阶段（2年）和 维持阶段（1年）。后来对紧急呼吁研究EBT的可持续性的回应。 在复制有效计划（REP）框架的指导下，在此混合类型1，4年研究中，8 CMHC 临床部位将被簇簇为随机的标准或适应性反式C。然后，在每个CMHC站点中， 患者将被随机分配到即时C-C或通常的护理，然后进行延迟治疗（UC-DT）。一个 共有96名提供者和576名患者将参加。治疗前，中和治疗将评估患者 并在6个月的随访中。加州大学伯克利分校将协调研究，促进实施，收集数据 等等。在已建立的CMHC网络中的提供商将实现Trans-C。 SA1是要确认这两个 与UC-DT相比，标准与改装的反式C，改善了睡眠和昼夜节律的功能并降低 功能障碍和以障碍为中心的精神病症状。 SA2是为了评估拟合度，对CMHC 标准与改编的trans-c的上下文。 SA3会检查是否更好地拟合 治疗状况和患者结果。这项研究将确定睡眠和昼夜节律问题是否可以 在CMHC设置中有效解决了SMI，测试Trans-C的两种变体，每个变体都有唯一的 优势和关注社区提供者和典型的社区患者。