Student mental health outcomes of a clustered SMART for developing an adaptive implementation strategy to support school-based CBT delivery.

PURPOSE: Most youth experiencing anxiety/depression lack access to evidence-based mental health practices (EBPs). School-delivered care improves access, and various support can help school professionals (SPs; school social workers, counselors) deliver EBPs, like Cognitive Behavioral Therapy (CBT). Understanding implementation strategies' impact on downstream mental health outcomes is crucial to scaling up EBPs to address the treatment gap, but it has rarely been assessed. METHODS: This paper compares implementation strategies' impact on change in student outcomes, collected as exploratory outcomes from a type III hybrid implementation-effectiveness trial. A clustered, sequential, multiple-assignment randomized trial design was used, which embedded four implementation supports that differentially sequence three implementation strategies, Replicating Effective Programs (REP), Coaching, and Facilitation. Prior to the first randomization, N = 169 SPs from 94 Michigan high schools each identified up to 10 students whom they believed could benefit from CBT and facilitated student survey completion. Changes in students' depression (Patient Health Questionnaire-9, modified for teens) and anxiety symptoms (Generalized Anxiety Disorder-7) over 10 months were compared across the four sequences of implementation support using a generalization of a marginal, weighted least squares approach developed for a clustered SMARTs. RESULTS: Small, non-clinically significant reductions in symptoms over the study period were found. Pairwise comparisons found no significant differences in symptom change across the four implementation strategies. The difference in the estimated mean PHQ-9T/GAD-7 scores between the least and the most intensive strategies (REP vs. REP+Coaching+Facilitation) was 1.04 (95%CI = -0.95, 3.04) for depression and 0.82 (95%CI = -0.89, 2.52) for anxiety. DISCUSSION: No difference in symptom change was found across the four implementation strategies. Multiple forms of implementation support may be useful for improving student mental health outcomes. TRIAL REGISTRATION: NCT03541317-Registered on 29 May 2018 on ClinicalTrials.gov PRS.

Building on Strong Foundations: Deploying Enhanced Replicating Effective Programs for evidence-based prevention curriculum adaptation.

Schools frequently adopt new interventions for each new public health issue, but this is both time- and resource-intensive. Adversity exposure is an example of a pervasive public health issue that emerged during Coronavirus Disease 2019 (COVID-19) with notable consequences, including an elevated risk of developing substance use disorders and mental illnesses. Adapting existing, universal, evidence-based interventions, such as the Michigan Model for HealthTM (MMH), by incorporating trauma-sensitive content is a promising approach to meet this need. We examined critical steps in promoting MMH adaptability as part of the Enhanced REP (Replicating Effective Programs) implementation strategy during the COVID-19 pandemic. We share usability testing from the 2020 to 2021 school year and describe how we apply the results to inform the group randomized trial pilot study. We applied key steps from implementation adaptation frameworks to integrate trauma-sensitive content as COVID-19 unfolded, documenting the process through field notes. We conducted initial usability testing with two teachers via interviews and used a rapid qualitative analysis approach. We conducted member checking by sharing the information with two health coordinators to validate results and inform additional curriculum refinement. We developed an adapted MMH curriculum to include trauma-sensitive content, with adaptations primarily centered on adding content, tailoring content, substituting content, and repeating/reinforcing elements across units. We designed adaptations to retain the core functional elements of MMH. Building foundational relationships and infrastructure supports opportunities to user-test intervention materials for Enhanced REP that enhance utility and relevance for populations that would most benefit. Enhanced REP is a promising strategy to use an existing evidence-based intervention to meet better the needs of youth exposed to adversity. Building on the foundations of existing evidence-based interventions, is vital to implementation success and achieving desired public health outcomes.

Schools frequently adopt new interventions for each new public health issue that may or may not be evidence-based. Concentrating efforts on supporting the effective implementation of existing, widely adopted evidence-based interventions (EBIs) in schools is an efficient and effective way to achieve their public health impact and reduce implementer overload. We systematically adapted an EBI, the Michigan Model for HealthTM, to incorporate trauma-sensitive content and pilot-tested the materials with two health teachers using pre-/post-interviews to gather feedback for refinement. The implementation support professionals­regional school health coordinators­provided further insight and validation of teacher feedback on adaptations. The adaptations developed focused on maintaining the core functions that make the curriculum effective. We learned that the foundational relationships and implementation infrastructure were central to testing intervention materials in a way that would enhance utility and relevance for the student population that would most benefit. Leveraging available infrastructure and existing collaborations are vital to implementation success and achieving desired public health outcomes.

Mental Health and Cognition in Women Veterans Enrolled in the Health of Vietnam Era Veteran Women's Study (HealthViEWS).

Objective: This analysis explored relationships between mental health symptoms and conditions and cognitive function in a cohort of Vietnam-era women veterans from the Health of Vietnam Era Veteran Women's Study (HealthViEWS). Methods: Vietnam-era women veterans completed a mail survey assessing self-reported symptom severity of posttraumatic stress disorder (PTSD) and depression. A telephone-based structured interview assessed mental health conditions and cognitive function (telephone interview for cognitive status [TICS]). Participants were categorized using a TICS threshold of ≤29 to designate possible cognitive impairment versus nonimpaired. Separate logistic regression models were used to determine associations between possible cognitive impairment and each self-reported and interviewer-rated assessment of PTSD and depression while adjusting for age, education, race, marital status, and wartime service location. Results: The sample consisted of 4,077 women veterans who were ≥60 years old and completed the TICS. Of these women, 7.20% were categorized with possible cognitive impairment. Logistic regression models indicated that self-reported PTSD and depression symptom severity were each significantly associated with higher odds of possible cognitive impairment (adjusted odds ratios [aOR]: 1.03 [95% confidence interval [CI]: 1.02-1.04] and 1.07 [95% CI: 1.04-1.09], respectively). Women veterans with a probable diagnosis of depression had higher odds of possible cognitive impairment compared to those without depression (aOR: 1.61 [95% CI: 1.07-2.42]). No association was found for probable diagnosis of PTSD. Conclusions: Although further examination remains necessary, results suggest that Vietnam-era women veterans with self-reported PTSD and depression symptom severity or a probable diagnosis of depression may benefit from screening of cognitive function to inform clinical care.

Associations between Posttraumatic Stress Disorder and Diabetes in Vietnam-Era Women Veterans in the HealthViEWS Study.

Background: Posttraumatic stress disorder (PTSD) is associated with incident diabetes. However, past studies have often included predominantly male samples, despite important sex and gender differences in diabetes. To address this limitation, this study examined the association between PTSD and diabetes in older Veteran women, a population with a high burden of PTSD. Materials and Methods: Data were collected from 4,105 women (Mage = 67.4 years), participating in the Health of Vietnam-Era Veteran Women's Study (HealthViEWS; Department of Veterans Affairs Cooperative Studies Program #579). Participants completed self-report measures of demographics, health conditions, and health behaviors. Information on military service was obtained through service records. A structured clinical interview was conducted by telephone to assess current and lifetime PTSD and other mental health disorders. Weighted descriptive and logistic regression analyses were used to examine associations between PTSD and diabetes. Results: The prevalence of diabetes was 28.4% among women with current full PTSD compared to 23.4%, 17.6%, and 17.5% for current subthreshold, remitted, and no PTSD. In unadjusted analyses, women with current full and subthreshold PTSD were 1.87 [1.49; 2.33] and 1.44 [1.11; 1.85] times more likely to have diabetes compared to women with no PTSD. Remitted PTSD was not associated with increased odds of diabetes. Effects were attenuated but remained significant after adjustment for relevant covariates. Conclusions: Vietnam-era women with current PTSD, including subthreshold symptoms, had a greater likelihood of diabetes compared to women without PTSD. These findings suggest that women with PTSD may benefit from increased diabetes prevention efforts.

Work-Related Cognitive Behavioral Therapy for racially and economically diverse unemployed persons with social anxiety: A randomized clinical trial.

Individuals with Social Anxiety Disorder (SAD) are at risk for employment problems. This multi-site trial examined the efficacy of Work-Related Cognitive Behavioral Therapy provided alongside vocational services as usual (WCBT+VSAU), a group-based treatment designed to improve mental health and employment outcomes for individuals with SAD. Vocational service-seeking participants with SAD (N = 250) were randomized to either WCBT+VSAU or VSAU-alone. Hypotheses were that participants randomized to WCBT+VSAU would report less social anxiety, less depression, and more hours worked than participants randomized to VSAU-alone. WCBT+VSAU participants had significantly greater improvements on the Liebowitz Social Anxiety Scale (LSAS; d=-.25, CI=-0.49 to -0.02, p = .03) at post-assessment compared to VSAU-alone. The conditions did not differ on any variable at later time points or on secondary outcomes. Unexpectedly, participants randomized to VSAU-alone experienced LSAS improvements, similar to WCBT+VASU at later timepoints. Baseline psychological flexibility (beta=-.098 [-0.19-0.008]) and depression (beta=-0.18 [-0.34-0.009]) moderated change in social anxiety. Participants with lower psychological flexibility and higher depression responded more strongly to WCBT+VSAU than VSAU-alone over the duration of the study, suggesting that WCBT+VSAU may particularly benefit those with greater psychopathology. Results indicate that vocational centers are promising settings for treating SAD and employment-focused refinements are likely needed to improve work outcomes.

Real-World Depression Screening Practices Among Primary Care Providers Across Patient-Level and Provider-Level Characteristics.

This study examined primary care provider (PCP) alignment with guideline-based care for adolescent depression screening and identified factors associated with post-screening responses. A retrospective chart review was conducted across 17 primary care clinics. Logistical regressions were estimated across provider specialties, sociodemographic factors, and patient clinical histories. Significant differences in follow-up and identification of depression were found among patients with more severe depression presentation. Follow-up screening was also more likely to be completed among patients with private insurance and less likely to occur among Black patients. Patients with significant mental health history of a mood concern, history of being prescribed psychotropic medication, were currently on medications at the time of the screening, or had a history of an internal mental health referral had a higher predicted probability of being identified as depressed on the patient problem list.

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.

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.

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.

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. https://classic.clinicaltrials.gov/ct2/show/NCT05956678?term=NCT05956678&draw=2&rank=1.

A mixed methods partner-focused cost and budget impact analysis to deploy implementation strategies for school-based prevention.

BACKGROUND: Obtaining information on implementation strategy costs and local budget impacts from multiple perspectives is essential to data-driven decision-making about resource allocation for successful evidence-based intervention delivery. This mixed methods study determines the costs and priorities of deploying Enhanced Replicating Effective Programs (REP) to implement the Michigan Model for Health™, a universal school-based prevention intervention, from key shareholder perspectives. METHODS: Our study included teachers in 8 high schools across 3 Michigan counties as part of a pilot cluster randomized trial. We used activity-based costing, mapping key Enhanced REP activities across implementation phases. We included multiple perspectives, including state agencies, regional education service agencies, lead organization, and implementers. We also conducted a budget impact analysis (BIA, assessing the potential financial impact of adopting Enhanced REP) and a scenario analysis to estimate replication and account for cost variability. We used an experimental embedded mixed methods approach, conducting semi-structured interviews and collecting field notes during the trial to expand and explain the cost data and the implications of costs across relevant perspectives. RESULTS: Based on trial results, we estimate costs for deploying Enhanced REP are $11,903/school, with an estimated range between $8263/school and $15,201/school. We estimate that adding four additional schools, consistent with the pilot, would cost $8659/school. Qualitative results indicated misalignment in school and teacher priorities in some cases. Implementation activities, including training and implementation facilitation with the health coordinator, were sometimes in addition to regular teaching responsibilities. The extent to which this occurred was partly due to leadership priorities (e.g., sticking to the district PD schedule) and organizational priorities (e.g., budget). CONCLUSIONS: Previous research findings indicate that, from a societal perspective, universal prevention is an excellent return on investment. However, notable misalignment in cost burden and priorities exists across shareholder groups. Our results indicate significant personal time costs by teachers when engaging in implementation strategy activities that impose an opportunity cost. Additional strategies are needed to improve the alignment of costs and benefits to enhance the success and sustainability of implementation. We focus on those perspectives informed by the analysis and discuss opportunities to expand a multi-level focus and create greater alignment across perspectives. TRIAL REGISTRATION: ClinicalTrials.gov NCT04752189. Registered on 12 February 2021.

Adaptive Designs in Implementation Science and Practice: Their Promise and the Need for Greater Understanding and Improved Communication.

The promise of adaptation and adaptive designs in implementation science has been hindered by the lack of clarity and precision in defining what it means to adapt, especially regarding the distinction between adaptive study designs and adaptive implementation strategies. To ensure a common language for science and practice, authors reviewed the implementation science literature and found that the term adaptive was used to describe interventions, implementation strategies, and trial designs. To provide clarity and offer recommendations for reporting and strengthening study design, we propose a taxonomy that describes fixed versus adaptive implementation strategies and implementation trial designs. To improve impact, (a) future implementation studies should prespecify implementation strategy core functions that in turn can be taught to and replicated by health system/community partners, (b) funders should support exploratory studies that refine and specify implementation strategies, and (c) investigators should systematically address design requirements and ethical considerations (e.g., randomization, blinding/masking) with health system/community partners. Expected final online publication date for the Annual Review of Public Health, Volume 45 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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.

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 Validity and Reliability of the Workplace Culture of Health Scale-Short Form.

OBJECTIVE: A positive workplace culture of health can have significant benefits for both employees and organizations. The objective of this study was to test the validity and reliability of the Workplace Culture of Health (COH) Scale-Short Form. METHODS: We conducted a confirmatory factor analysis on data collected from a sample of 12,907 employees across 14 organizations. We examined the construct validity of the 14-item short-form version of the Workplace COH scale and assessed its reliability using internal consistency measures. RESULTS: Our confirmatory factor analysis demonstrated that the Workplace COH Scale-Short Form had strong model fit, indicating good construct validity. In addition, we found that all constructs had strong internal consistency reliability. CONCLUSIONS: Findings suggest that the Workplace COH Scale-Short Form is a valid and reliable way to practically assess workplace culture of health from the employee perspective.

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.

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 (b) providers' perceptions of fit. Methods: TTT will be implemented in nine CMHCs in California, United States (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 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. Trial registration: Clinicaltrials.gov identifier: NCT05805657. Registered on April 10, 2023. https://clinicaltrials.gov/ct2/show/NCT05805657.

How does facilitation in healthcare work? Using mechanism mapping to illuminate the black box of a meta-implementation strategy.

BACKGROUND: Healthcare facilitation, an implementation strategy designed to improve the uptake of effective clinical innovations in routine practice, has produced promising yet mixed results in randomized implementation trials and has not been fully researched across different contexts. OBJECTIVE: Using mechanism mapping, which applies directed acyclic graphs that decompose an effect of interest into hypothesized causal steps and mechanisms, we propose a more concrete description of how healthcare facilitation works to inform its further study as a meta-implementation strategy. METHODS: Using a modified Delphi consensus process, co-authors developed the mechanistic map based on a three-step process. First, they developed an initial logic model by collectively reviewing the literature and identifying the most relevant studies of healthcare facilitation components and mechanisms to date. Second, they applied the logic model to write vignettes describing how facilitation worked (or did not) based on recent empirical trials that were selected via consensus for inclusion and diversity in contextual settings (US, international sites). Finally, the mechanistic map was created based on the collective findings from the vignettes. FINDINGS: Theory-based healthcare facilitation components informing the mechanistic map included staff engagement, role clarification, coalition-building through peer experiences and identifying champions, capacity-building through problem solving barriers, and organizational ownership of the implementation process. Across the vignettes, engagement of leaders and practitioners led to increased socialization of the facilitator's role in the organization. This in turn led to clarifying of roles and responsibilities among practitioners and identifying peer experiences led to increased coherence and sense-making of the value of adopting effective innovations. Increased trust develops across leadership and practitioners through expanded capacity in adoption of the effective innovation by identifying opportunities that mitigated barriers to practice change. Finally, these mechanisms led to eventual normalization and ownership of the effective innovation and healthcare facilitation process. IMPACT: Mapping methodology provides a novel perspective of mechanisms of healthcare facilitation, notably how sensemaking, trust, and normalization contribute to quality improvement. This method may also enable more efficient and impactful hypothesis-testing and application of complex implementation strategies, with high relevance for lower-resourced settings, to inform effective innovation uptake.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial.

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.

A Community-Engaged Process for Adapting a Cardiovascular Health Intervention for Persons with Serious Mental Illness.

Introduction: People with serious mental illness experience grave disparities in cardiovascular disease risk factors. To promote scale-up of effective cardiovascular disease risk reduction interventions from clinical trials, it is important to involve end-users in adapting interventions to fit the needs of community-based settings. Objective: We describe a novel, theory-informed process of garnering community input to adapt IDEAL Goals, an evidence-based intervention for improving cardiovascular disease risk factors in persons with serious mental illness. Setting: Outpatient community mental health programs in Maryland and Michigan implementing behavioral health homes, which provide enhanced support to people living with both physical and mental illnesses. Participants: Clinicians, frontline staff, and administrators from community mental health organizations and persons with serious mental illness. Methods: Our approach to community engagement is based on the Replicating Effective Programs (REP) framework. During the REP preimplementation phase, we used 2 community engagement activities: (1) a "needs assessment" to identify anticipated implementation barriers and facilitators, and (2) "community working groups" to collaboratively engage with end-users in adapting the intervention and implementation strategies. Main Findings: We used the Stakeholder Engagement Reporting Questionnaire to describe our processes for conducting a needs assessment, involving site-level surveys (N=26) and individual interviews (N=94), and convening a series of community working groups with clinicians and staff (mean, 24 per meeting) and persons with serious mental illness (mean, 8 per meeting). Conclusions: By specifying the nature and extent of our community engagement activities, we aim to contribute to the evidence base of how to better integrate and measure community-engaged processes in the adaptation of evidence-based interventions.