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

Abstract

Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov identifier NCT05805657. Registered on April 10, 2023.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial

“…The facilitation team transitioned CMHC sites to the Train-the-Trainer Phase on a rolling basis. The first site was transitioned to the Train-the-Trainer Phase in December 2020, and all sites were transitioned by December 2022 [ 33 , 34 ]. During the Train-the-Trainer Phase, the facilitators engaged in the following: recruiting, training, and providing consultation for local CMHC trainers; recruiting and enrolling providers and patients; holding as-needed consultation for TranS-C providers; offering certification in sleep treatment and sleep training; processing CEUs; and organizing regular meetings with CMHC leadership to problem-solve barriers.…”

“…Additionally, as CMHC providers and trainers gained mastery and independence, the facilitation team gradually transferred the following responsibilities to them: TranS-C trainings, clinical supervision, presentations on advanced topics to other providers, and cross-county consultation among trainers (termed the “Sleep Expert Network”). Additional details about the Train-the-Trainer Phase are reported elsewhere [ 34 ].…”

“…In phase 1 of the trial, the Implementation Phase, sites were cluster randomized by county to Standard TranS-C or Adapted TranS-C with 1:1 allocation, and external facilitation was used to help implement TranS-C in partnering CMHCs [ 33 ]. In phase 2, the Train-the-Trainer Phase, CMHC providers were trained by facilitators to train and supervise their colleagues in the delivery of TranS-C [ 34 ]. See below for more details.…”