The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer

Trials

Study Protocol

Lu Dong¹  Eric Stice²  Heather E. Hilmoe Yates³  Allison G. Harvey³  Laurel D. Sarfan³  Julia M. Spencer³  Catherine A. Callaway³  Emma R. Agnew³  Shayna A. Howlett³  Krista R. Fisher³  Marlen Diaz³  Rafael Esteva Hache³  Amy M. Kilbourne⁴  Daniel J. Buysse⁵ 

[1] RAND Corporation, Santa Monica, CA, USA;Stanford University, Stanford, CA, USA;University of California, Berkeley, CA, USA;University of Michigan and VA Ann Arbor Healthcare System, Ann Arbor, MI, USA;University of Pittsburgh, Pittsburgh, PA, USA;

关键词: Train-the-trainer;    Transdiagnostic;    Sleep;    Circadian;    Serious mental illness;    Implementation;    Sustainment;    Adaptation;    Community mental health;   

DOI  :  10.1186/s13063-023-07523-6

 received in 2023-05-16, accepted in 2023-07-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundTrain-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.MethodsTTT 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.DiscussionThis 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.Trial registrationClinicalTrials.gov identifier NCT05805657. Registered on April 10, 2023.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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