Callaway Catherine A, Sarfan Laurel D, Agnew Emma R, Dong Lu, Spencer Julia M, Hache Rafael Esteva, Diaz Marlen, Howlett Shayna A, Fisher Krista R, Yates Heather E Hilmoe, Stice Eric, Kilbourne Amy M, Buysse Daniel J, Harvey Allison G
University of California Berkeley.
RAND Corporation.
Res Sq. 2023 Jun 17:rs.3.rs-2943787. doi: 10.21203/rs.3.rs-2943787/v1.
Train-the-trainer (TTT) is a promising method for implementing evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs). In TTT, expert trainers train locally embedded individuals (i.e., Generation 1 providers) to deliver an EBPT, who then train others (i.e., Generation 2 providers). The present study will evaluate implementation and effectiveness outcomes of an EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)-delivered to CMHC patients with serious mental illness by Generation 2 providers (i.e., trained and supervised within CMHCs via TTT). Specifically, we will investigate whether adapting TranS-C to fit CMHC contexts improves Generation 2 (a) patient outcomes (b) providers' perceptions of fit.
TTT will be implemented in nine CMHCs in California, United States ( 60 providers; 130 patients) via facilitation. CMHCs are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each CMHC, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will assess the effectiveness of TranS-C (combined Adapted and Standard), compared to UC-DT, on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms for Generation 2 patients. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to Generation 2 providers' perceptions of fit. Aim 3 will evaluate whether Generation 2 providers' perceived fit mediates the relation between TranS-C treatment condition and patient outcomes. Exploratory analyses will: (1) evaluate whether the effectiveness of TranS-C for patient outcomes is moderated by generation, (2) compare Adapted and Standard TranS-C on patient perceptions of credibility/improvement and PhenX Toolkit outcomes (e.g., substance use, suicidality); and (3) evaluate other possible moderators.
This trial has potential to inform the process of (a) embedding local trainers and supervisors to expand delivery of a promising transdiagnostic treatment for sleep and circadian dysfunction, (b) adding to the growing body of TTT literature by evaluating TTT outcomes with a novel treatment and population, and (c) advancing our understanding of providers' perceptions of EBPT 'fit' across TTT generations.
Clinicaltrials.gov identifier: NCT05805657. Registered on April 10, 2023. https://clinicaltrials.gov/ct2/show/NCT05805657.
培训培训师（TTT）是在社区心理健康中心（CMHC）实施循证心理治疗（EBPT）的一种很有前景的方法。在TTT中，专家培训师培训当地的专职人员（即第一代提供者）来提供一种EBPT，这些第一代提供者随后再培训其他人（即第二代提供者）。本研究将评估第二代提供者（即在CMHC内通过TTT进行培训和监督）向患有严重精神疾病的CMHC患者提供的一种针对睡眠和昼夜节律功能障碍的EBPT——睡眠和昼夜节律功能障碍的跨诊断干预（TranS-C）的实施情况和有效性结果。具体而言，我们将调查使TranS-C适应CMHC的环境是否能改善第二代（a）患者的治疗结果（b）提供者对适应性的看法。
将通过促进的方式在美国加利福尼亚州的9个CMHC中实施TTT（60名提供者；130名患者）。CMHC按县进行整群随机分组，分为适应性TranS-C组或标准TranS-C组。在每个CMHC内，患者被随机分配接受即刻TranS-C治疗或常规护理，随后接受TranS-C延迟治疗（UC-DT）。目标1将评估与UC-DT相比，TranS-C（适应性和标准TranS-C合并）对第二代患者睡眠和昼夜节律问题、功能损害及精神症状改善的有效性。目标2将评估适应性TranS-C在第二代提供者对适应性的看法方面是否优于标准TranS-C。目标3将评估第二代提供者所感知的适应性是否介导TranS-C治疗条件与患者治疗结果之间的关系。探索性分析将：（1）评估TranS-C对患者治疗结果的有效性是否受代际的调节，（2）比较适应性TranS-C和标准TranS-C在患者对可信度/改善情况的看法以及PhenX工具包结果（如物质使用、自杀倾向）方面的差异；以及（3）评估其他可能的调节因素。
这项试验有可能为以下过程提供信息：（a）嵌入当地培训师和监督员以扩大针对睡眠和昼夜节律功能障碍的有前景的跨诊断治疗的提供范围，（b）通过用一种新的治疗方法和人群评估TTT结果来增加不断增长的TTT文献，以及（c）推进我们对TTT各代提供者对EBPT“适应性”看法的理解。
Clinicaltrials.gov标识符：NCT05805657。于2023年4月10日注册。https://clinicaltrials.gov/ct2/show/NCT05805657。
