University of California, Berkeley, CA, USA.
RAND Corporation, Santa Monica, CA, USA.
Trials. 2023 Aug 7;24(1):503. doi: 10.1186/s13063-023-07523-6.
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 and (b) providers' perceptions of fit.
TTT will be implemented in nine CMHCs in California, USA (N = 60 providers; N = 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 (a) inform the process of embedding local trainers and supervisors to expand delivery of a promising transdiagnostic treatment for sleep and circadian dysfunction, (b) add to the growing body of TTT literature by evaluating TTT outcomes with a novel treatment and population, and (c) advance our understanding of providers' perceptions of EBPT "fit" across TTT generations.
ClinicalTrials.gov identifier NCT05805657 . Registered on April 10, 2023.
培训师培训（TTT）是在社区心理健康中心（CMHC）实施基于证据的心理治疗（EBPT）的一种很有前途的方法。在 TTT 中，专家培训师培训在当地嵌入的个体（即第一代提供者）提供 EBPT，然后由他们培训其他人（即第二代提供者）。本研究将评估通过第二代提供者（即在 CMHC 内通过 TTT 培训和监督的人）为患有严重精神疾病的 CMHC 患者提供的睡眠和昼夜节律障碍的跨诊断干预（Transdiagnostic Intervention for Sleep and Circadian Dysfunction，TranS-C）的实施和有效性结果。具体来说，我们将调查是否调整 TranS-C 以适应 CMHC 环境会改善第二代（a）患者结果和（b）提供者对适应度的看法。
TTT 将通过促进在加利福尼亚州的 9 个 CMHC 中实施（N=60 名提供者；N=130 名患者）。CMHC 按县进行集群随机分配，适应 TranS-C 或标准 TranS-C。在每个 CMHC 内，患者随机接受立即 TranS-C 或常规护理，然后延迟接受 TranS-C（UC-DT）治疗。目标 1 将评估与 UC-DT 相比，TranS-C（综合适应和标准）对第二代患者睡眠和昼夜节律问题、功能障碍和精神症状的改善的有效性。目标 2 将评估适应 TranS-C 是否优于标准 TranS-C，在第二代提供者对适应度的看法方面。目标 3 将评估第二代提供者对适应度的感知是否在 TranS-C 治疗条件与患者结果之间的关系中起中介作用。探索性分析将（1）评估 TranS-C 对患者结果的有效性是否受代际影响，（2）比较适应和标准 TranS-C 对患者对可信度/改善的感知和 PhenX 工具包结果（例如，物质使用，自杀），以及（3）评估其他可能的调节因素。
这项试验有可能（a）为在当地培训师和主管人员的基础上扩大睡眠和昼夜节律障碍的有前途的跨诊断治疗提供信息，（b）通过评估具有新治疗方法和人群的 TTT 结果，为不断增长的 TTT 文献做出贡献，以及（c）提高我们对 EBPT“适应度”的理解在 TTT 代际中。
ClinicalTrials.gov 标识符 NCT05805657。于 2023 年 4 月 10 日注册。
