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.
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.
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.
Mental Disorders , Mental Health , Humans , Sleep , Surveys and Questionnaires , Community Mental Health Centers , Mental Disorders/diagnosis , Mental Disorders/therapy , Mental Disorders/psychology , Randomized Controlled Trials as Topic
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.
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.
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.
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.
Mental Disorders , Mental Health , Humans , Treatment Outcome , Mental Disorders/diagnosis , Mental Disorders/therapy , Mental Disorders/psychology , Sleep , Community Mental Health Centers , Randomized Controlled Trials as Topic
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.
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.
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.
Mental Disorders , Mental Health , Humans , Mental Disorders/diagnosis , Mental Disorders/therapy , Mental Disorders/psychology , Sleep , Implementation Science , Randomized Controlled Trials as Topic
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.
Cardiovascular Diseases , Mental Disorders , Humans , Mental Disorders/therapy , Cardiovascular Diseases/prevention & control , Maryland , Community Mental Health Services/organization & administration , Michigan , Needs Assessment , Community Participation , Female , Stakeholder Participation
Background: Persons with serious mental illnesses (SMIs) experience disparities in health care and are more likely to die from physical health conditions than the general population. Behavioral health homes are used in public sector mental health programs to deploy collaborative care to improve physical health for those with SMIs. During the COVID-19 pandemic, these programs faced new challenges in delivering care to this vulnerable group. Purpose: To describe barriers to implementing or sustaining behavioral health homes, experienced by community mental health workers during the COVID-19 pandemic, and the strategies used to address these challenges. Methods: In-depth qualitative interviews were conducted among the behavioral health workforce in Maryland and Michigan community mental health programs. Interview questions were derived from the Consolidated Framework for Implementation Research (CFIR), and responses related to implementing and sustaining health homes during the pandemic were coded and themes were analyzed by using an inductive approach. Results: Overall, 72 staff members across 21 sites in Maryland and Michigan were interviewed. Implementation barriers/strategies identified occurred across multiple CFIR domains (client, mental health system, physical health system). Interviewees discussed technologic and nontechnologic challenges as well as strategies to address technology issues. Strategies were more frequently discussed by providers when the barrier was viewed at the client level (eg, low technology literacy) versus the broader system (eg, canceled primary care visits). Conclusions: Community mental health staff described barriers beyond technology in caring for individuals with SMIs and physical health conditions. Further research should examine how implementation strategies address both technologic and nontechnologic barriers to collaborative care.
COVID-19 , Community Mental Health Services , Humans , COVID-19/prevention & control , COVID-19/epidemiology , Maryland , Michigan , Community Mental Health Services/organization & administration , Mental Disorders/therapy , Female , SARS-CoV-2 , Qualitative Research , Male , Pandemics , Interviews as Topic
Objectives: The U.S. Department of Veterans Affairs (VA) has been a national leader in Learning Health System (LHS) implementation due to its combined mission of research, education, clinical care, and emergency preparedness. We describe the current VA LHS training ecosystem within the Veterans Health Administration's Office of Academic Affiliations (OAA), Office of Research and Development (ORD), ORD's Health Services Research and Development (HSR&D) program, and Innovation Ecosystem (IE), including lessons learned regarding their sustainment. Methods: The VA LHS training ecosystem is based on the Learning Loop and HSR&D Quality Enhancement Research Initiative (QUERI) Roadmap, which describes VA learning opportunities, underlying infrastructures, and core competencies. Results: VA-focused LHS educational programs include data-to-knowledge initiatives in health sciences and analytics, for example, OAA/HSR&D health services and informatics research fellowships; knowledge-to-performance opportunities in implementation and quality improvement, for example, QUERI Learning Hubs and IEs' Diffusion of Excellence Initiative; and performance-to-data embedded opportunities, for example, IE's entrepreneur fellowship programs and QUERI's Advancing Diversity in Implementation Leadership. These training programs are supported by combined VA research and clinical operations investments in funding, informatics, governance, and processes. Lessons learned include ongoing alignment of research funding with operational priorities and capacity, relentless recruitment and retention of implementation, system, and information scientists especially from under-represented groups, sustainment of data infrastructures suitable for research and quality improvement, and ensuring sustainable funding opportunities for researchers to work on system-wide health care problems. Conclusions: There is an urgent need to expand training opportunities in LHSs, especially as health care is increasingly driven by multiple interested parties, impacted by persistent health disparities exacerbated by emerging public health threats, and rapid technology growth. With ongoing alignment of research and clinical goals, foundational support through research funding, underlying clinical operations infrastructures, and active engagement interested parties, VA's LHS training ecosystem promotes a more LHS-savvy, 21st century workforce.
BACKGROUND: School-based drug use prevention programs have demonstrated notable potential to reduce the onset and escalation of drug use, including among youth at risk of poor outcomes such as those exposed to trauma. Researchers have found a robust relationship between intervention fidelity and participant (i.e., student) outcomes. Effective implementation of evidence-based interventions, such as the Michigan Model for HealthTM (MMH), is critical to achieving desired public health objectives. Yet, a persistent gap remains in what we know works and how to effectively translate these findings into routine practice. The objective of this study is to design and test a multi-component implementation strategy to tailor MMH to meet population needs (i.e., students exposed to trauma), and improve the population-context fit to enhance fidelity and effectiveness. METHODS: Using a 2-group, mixed-method randomized controlled trial design, this study will compare standard implementation versus Enhanced Replicating Effective Programs (REP) to deliver MMH. REP is a theoretically based implementation strategy that promotes evidence-based intervention (EBI) fidelity through a combination of EBI curriculum packaging, training, and as-needed technical assistance and is consistent with standard MMH implementation. Enhanced REP will tailor the intervention and training to integrate trauma-informed approaches and deploy customized implementation support (i.e., facilitation). The research will address the following specific aims: (1) design and test an implementation strategy (Enhanced REP) to deliver the MMH versus standard implementation and evaluate feasibility, acceptability, and appropriateness using mixed methods, (2) estimate the costs and cost-effectiveness of Enhanced REP to deliver MMH versus standard implementation. DISCUSSION: This research will design and test a multi-component implementation strategy focused on enhancing the fit between the intervention and population needs while maintaining fidelity to MMH core functions. We focus on the feasibility of deploying the implementation strategy bundle and costing methods and preliminary information on cost input distributions. The substantive focus on youth at heightened risk of drug use and its consequences due to trauma exposure is significant because of the public health impact of prevention. Pilot studies of implementation strategies are underutilized and can provide vital information on designing and testing effective strategies by addressing potential design and methods uncertainties and the effects of the implementation strategy on implementation and student outcomes. TRIAL REGISTRATION: NCT04752189-registered on 8 February 2021 on ClinicalTrials.gov PRS.
BACKGROUND: Schools increasingly provide mental health services to students, but often lack access to implementation strategies to support school-based (and school professional [SP]) delivery of evidence-based practices. Given substantial heterogeneity in implementation barriers across schools, development of adaptive implementation strategies that guide which implementation strategies to provide to which schools and when may be necessary to support scale-up. METHODS: A clustered, sequential, multiple-assignment randomized trial (SMART) of high schools across Michigan was used to inform the development of a school-level adaptive implementation strategy for supporting SP-delivered cognitive behavioral therapy (CBT). All schools were first provided with implementation support informed by Replicating Effective Programs (REP) and then were randomized to add in-person Coaching or not (phase 1). After 8 weeks, schools were assessed for response based on SP-reported frequency of CBT delivered to students and/or barriers reported. Responder schools continued with phase 1 implementation strategies. Slower-responder schools (not providing ≥ 3 CBT components to ≥10 students or >2 organizational barriers identified) were re-randomized to add Facilitation to current support or not (phase 2). The primary aim hypothesis was that SPs at schools receiving the REP + Coaching + Facilitation adaptive implementation strategy would deliver more CBT sessions than SPs at schools receiving REP alone. Secondary aims compared four implementation strategies (Coaching vs no Coaching × Facilitation vs no Facilitation) on CBT sessions delivered, including by type (group, brief and full individual). Analyses used a marginal, weighted least squares approach developed for clustered SMARTs. RESULTS: SPs (n = 169) at 94 high schools entered the study. N = 83 schools (88%) were slower-responders after phase 1. Contrary to the primary aim hypothesis, there was no evidence of a significant difference in CBT sessions delivered between REP + Coaching + Facilitation and REP alone (111.4 vs. 121.1 average total CBT sessions; p = 0.63). In secondary analyses, the adaptive strategy that offered REP + Facilitation resulted in the highest average CBT delivery (154.1 sessions) and the non-adaptive strategy offering REP + Coaching the lowest (94.5 sessions). CONCLUSIONS: The most effective strategy in terms of average SP-reported CBT delivery is the adaptive implementation strategy that (i) begins with REP, (ii) augments with Facilitation for slower-responder schools (schools where SPs identified organizational barriers or struggled to deliver CBT), and (iii) stays the course with REP for responder schools. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03541317 , May 30, 2018.
Cognitive Behavioral Therapy , Mental Health Services , Cognitive Behavioral Therapy/methods , Humans , Michigan , Schools
This paper presents a methodological description of a randomized controlled trial (RCT) testing the effect of Raising Our Spirits Together (ROST), a technology-assisted cognitive behavioral therapy (T-CBT) for depression, tailored for the rural context and for delivery by clergy, compared to an enhanced control condition. Depression is among the most common mental health conditions; yet the majority of adults with depression do not receive needed treatment due to limited access to mental health professionals, treatment-associated costs, distance to care, and stigma. These barriers are particularly salient in rural areas of the United States. T-CBT with human support is an accessible and effective treatment for depression; however, currently available T-CBTs have poor completion rates due to the lack of tailoring and other features to support engagement. ROST is a T-CBT specifically tailored for the rural setting and delivery by clergy, who are preferred, informal providers. ROST also presents core CBT content in a simple, jargon-free manner that supports multiple learning preferences. ROST is delivered virtually in a small group format across 8 weekly sessions via videoconferencing software consistent with other clergy-based programs, such as Bible studies or self-help groups. In this study, adults with depressive symptoms recruited from two rural Michigan counties will be randomized to receive ROST versus an enhanced control condition (N = 84). Depressive symptoms post-treatment and at 3 months follow-up according to the Patient Health Questionnaire (PHQ-9) will be the primary outcome. Findings will determine whether ROST is effective for improving depression symptoms in underserved, under resourced rural communities.
Importance: Selecting effective antidepressants for the treatment of major depressive disorder (MDD) is an imprecise practice, with remission rates of about 30% at the initial treatment. Objective: To determine whether pharmacogenomic testing affects antidepressant medication selection and whether such testing leads to better clinical outcomes. Design, Setting, and Participants: A pragmatic, randomized clinical trial that compared treatment guided by pharmacogenomic testing vs usual care. Participants included 676 clinicians and 1944 patients. Participants were enrolled from 22 Department of Veterans Affairs medical centers from July 2017 through February 2021, with follow-up ending November 2021. Eligible patients were those with MDD who were initiating or switching treatment with a single antidepressant. Exclusion criteria included an active substance use disorder, mania, psychosis, or concurrent treatment with a specified list of medications. Interventions: Results from a commercial pharmacogenomic test were given to clinicians in the pharmacogenomic-guided group (n = 966). The comparison group received usual care and access to pharmacogenomic results after 24 weeks (n = 978). Main Outcomes and Measures: The co-primary outcomes were the proportion of prescriptions with a predicted drug-gene interaction written in the 30 days after randomization and remission of depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) (remission was defined as PHQ-9 ≤ 5). Remission was analyzed as a repeated measure across 24 weeks by blinded raters. Results: Among 1944 patients who were randomized (mean age, 48 years; 491 women [25%]), 1541 (79%) completed the 24-week assessment. The estimated risks for receiving an antidepressant with none, moderate, and substantial drug-gene interactions for the pharmacogenomic-guided group were 59.3%, 30.0%, and 10.7% compared with 25.7%, 54.6%, and 19.7% in the usual care group. The pharmacogenomic-guided group was more likely to receive a medication with a lower potential drug-gene interaction for no drug-gene vs moderate/substantial interaction (odds ratio [OR], 4.32 [95% CI, 3.47 to 5.39]; P < .001) and no/moderate vs substantial interaction (OR, 2.08 [95% CI, 1.52 to 2.84]; P = .005) (P < .001 for overall comparison). Remission rates over 24 weeks were higher among patients whose care was guided by pharmacogenomic testing than those in usual care (OR, 1.28 [95% CI, 1.05 to 1.57]; P = .02; risk difference, 2.8% [95% CI, 0.6% to 5.1%]) but were not significantly higher at week 24 when 130 patients in the pharmacogenomic-guided group and 126 patients in the usual care group were in remission (estimated risk difference, 1.5% [95% CI, -2.4% to 5.3%]; P = .45). Conclusions and Relevance: Among patients with MDD, provision of pharmacogenomic testing for drug-gene interactions reduced prescription of medications with predicted drug-gene interactions compared with usual care. Provision of test results had small nonpersistent effects on symptom remission. Trial Registration: ClinicalTrials.gov Identifier: NCT03170362.
Antidepressive Agents , Depressive Disorder, Major , Drug Interactions , Inappropriate Prescribing , Pharmacogenomic Testing , Antidepressive Agents/metabolism , Antidepressive Agents/pharmacology , Antidepressive Agents/therapeutic use , Clinical Decision-Making , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/genetics , Drug Interactions/genetics , Female , Humans , Inappropriate Prescribing/prevention & control , Male , Middle Aged , Pharmacogenetics , Remission Induction , Treatment Outcome , United States , United States Department of Veterans Affairs
Purpose: This pilot study assesses the association of Raising Our Spirits Together (ROST), a technology-assisted, group-based cognitive behavioral therapy for depression, with rural adults' depressive symptoms and anxiety. Method: Nine adults from rural Michigan participated in an open pilot of ROST. Clergy facilitated pilot groups. The pilot began in February 2020 in-person. Due to COVID-19, the pilot was completed virtually. Results: Mean depressive symptom scores, based on the PHQ-9, significantly decreased from pre-treatment (M = 14.4) to post-treatment (M = 6.33; t (8) = 6.79; P < .001). Symptom reduction was maintained at 3-month follow-up (M = 8.00), with a significant pattern of difference in depressive symptoms over time (F(2) = 17.7; P < .001; eta-squared = .689). Similar patterns occurred for anxiety based on the GAD-7. Participants attended an average of 7.33 of 8 sessions. Fidelity ratings were excellent. Discussion: ROST is a potentially feasible intervention for rural adults' depressive symptoms. ROST offers a promising model for increasing treatment access and building capacity in rural areas.
