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Abstract Background Poor memory for treatment is associated with poorer treatment adherence and poorer patient outcomes. The memory support intervention (MSI) was developed to improve patient memory for treatment with the goal of improving patient outcomes. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether a new, streamlined, and potent version of the MSI improves outcomes for midlife and older adults. This streamlined MSI is comprised of constructive memory supports that will be applied to a broader range of treatment content. The platform for this study is the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). We will focus on midlife and older adults who are low income and experiencing mobility impairments. Methods Participants (N = 178) will be randomly allocated to TranS-C + MSI or TranS-C alone. Both intervention arms include eight 50-min weekly sessions. Assessments will be conducted at pre-treatment, post-treatment, 6-, and 12-month follow-up (6FU and 12FU). Aim 1 will compare the effects of TranS-C + MSI versus TranS-C alone on sleep and circadian functioning, daytime functioning, well-being, and patient memory. Aim 2 will test whether patient memory for treatment mediates the relationship between treatment condition and patient outcomes. Aim 3 will evaluate if previously reported poor treatment response subgroups will moderate the relationship between treatment condition and (a) patient memory for treatment and (b) treatment outcome. Exploratory analyses will compare treatment condition on (a) patient adherence, patient-rated treatment credibility, and patient utilization of treatment contents, and (b) provider-rated acceptability, appropriateness, and feasibility. Discussion This study has the potential to provide evidence for (a) the efficacy of a new simplified version of the MSI for maintaining health, well-being, and functioning, (b) the wider application of the MSI for midlife and older adults and to the treatment of sleep and circadian problems, and (c) the efficacy of the MSI for sub-groups who are likely to benefit from the intervention. Trial registration ClinicalTrials.gov NCT05986604. Registered on 2 August 2023.

Abstract Background Although research on the implementation of evidence-based psychological treatments (EBPTs) has advanced rapidly, research on the sustainment of implemented EBPTs remains limited. This is concerning, given that EBPT activities and benefits regularly decline post-implementation. To advance research on sustainment, the present protocol focuses on the third and final phase—the Sustainment Phase—of a hybrid type 2 cluster-randomized controlled trial investigating the implementation and sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for patients with serious mental illness and sleep and circadian problems in community mental health centers (CMHCs). Prior to the first two phases of the trial—the Implementation Phase and Train-the-Trainer Phase—TranS-C was adapted to fit the CMHC context. Then, 10 CMHCs were cluster-randomized to implement Standard or Adapted TranS-C via facilitation and train-the-trainer. The primary goal of the Sustainment Phase is to investigate whether adapting TranS-C to fit the CMHC context predicts improved sustainment outcomes. Methods Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended and may continue for up to one year. CMHC providers will be recruited to complete surveys (N = 154) and a semi-structured interview (N = 40) on sustainment outcomes and mechanisms. Aim 1 is to report the sustainment outcomes of TranS-C. Aim 2 is to evaluate whether manipulating EBPT fit to context (i.e., Standard versus Adapted TranS-C) predicts sustainment outcomes. Aim 3 is to test whether provider perceptions of fit mediate the relation between treatment condition (i.e., Standard versus Adapted TranS-C) and sustainment outcomes. Mixed methods will be used to analyze the data. Discussion The present study seeks to advance our understanding of sustainment predictors, mechanisms, and outcomes by investigating (a) whether the implementation strategy of adapting an EBPT (i.e., TranS-C) to the CMHC context predicts improved sustainment outcomes and (b) whether this relation is mediated by improved provider perceptions of treatment fit. Together, the findings may help inform more precise implementation efforts that contribute to lasting change. Trial registration ClinicalTrials.gov identifier: NCT05956678 . Registered on July 21, 2023.

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.

Abstract Background Serious mental illness (SMI) can have devastating consequences. Unfortunately, many patients with SMI do not receive evidence-based psychological treatment (EBPTs) in routine practice settings. One barrier is poor “fit” between EBPTs and contexts in which they are implemented. The present study will evaluate implementation and effectiveness outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) implemented in community mental health centers (CMHCs). TranS-C was designed to target a range of SMI diagnoses by addressing a probable mechanism and predictor of SMI: sleep and circadian problems. We will investigate whether adapting TranS-C to fit CMHC contexts improves providers’ perceptions of fit and patient outcomes. Methods TranS-C will be implemented in at least ten counties in California, USA (N = 96 providers; N = 576 clients), via facilitation. CMHC sites are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each county, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will compare TranS-C (combined Adapted and Standard) with UC-DT on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms. Sleep and circadian problems will also be tested as a mediator between treatment condition (combined TranS-C versus UC-DT) and functional impairment/psychiatric symptoms. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to provider perceptions of fit. Aim 3 will evaluate whether the relation between TranS-C treatment condition (Adapted versus Standard) and patient outcomes is mediated by better provider perceptions of fit in the Adapted condition. Exploratory analyses will (1) compare Adapted versus Standard TranS-C on patient perceptions of credibility/improvement and select PhenX Toolkit outcomes and (2) evaluate possible moderators. Discussion This trial has the potential to (a) expand support for TranS-C, a promising transdiagnostic treatment delivered to patients with SMI in CMHCs; (b) take steps toward addressing challenges faced by providers in delivering EBPTs (i.e., high caseloads, complex patients, poor fit); and (c) advance evidence on causal strategies (i.e., adapting treatments to fit context) in implementation science. Trial registration Clinicaltrials.gov NCT04154631. Registered on 6 November 2019. https://clinicaltrials.gov/ct2/show/NCT04154631