Stanford Advisors


All Publications


  • A randomized trial of Adapted versus Standard versions the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Research square Harvey, A., Agnew, E. R., Hache, R. E., Callaway, C. A., Patino, E. O., Milner, A., Spencer, J. M., Diaz, M., Dong, L., Kilbourne, A. M., Buysse, D. J., Stice, E., Sarfan, L. D. 2025

    Abstract

    Background: Grounded in the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, we investigated the Train-the-Trainer (TTT) to expand access to evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs), focusing on the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC).Methods: Eight Californian counties were cluster-randomized to Standard TSC or an adapted version designed to improve the "fit" of TSC to CMHCs. University-based trainers trained CMHC providers ("Generation 1 providers") in either Adapted or Standard TSC. These trained providers were then trained to become local CMHC trainers ("Generation 1 trainers"), who then trained a new cohort of providers ("Generation 2 providers") in TSC. Within each county, patients diagnosed with serious mental illness (SMI) were randomized to receive either immediate TSC or usual care and delayed treatment with TSC (UC-DT) from the Generation 2 providers ("Generation 2 patients"). This study focused on 53 Generation 2 providers (Adapted TSC = 47; Standard TSC = 6), and 143 Generation 2 patients (Adapted TSC = 127; Standard TSC = 16) (the larger Adapted sample was driven by recruitment, perhaps reflecting preference for the "fitted" approach). Patient assessments were conducted pre-treatment, post-treatment, and six-month follow-up (6FU). Provider assessments occurred after completing TSC training and post-treatment for each patient treated.Results: Combining Adapted and Standard, TSC was associated with improvements for Generation 2 patients from pre- to post-treatment in sleep disturbance (p < 0.001, d = -0.90), sleep-related impairment (p = 0.001, d = -0.69), psychiatric symptoms (p = 0.002, d = -0.48), and functional impairment (p = 0.002, d = -0.54), relative to UC-DT. The effects of sleep disturbance and impairment on the relationship between treatment condition (TSC vs. UC-DT) and psychiatric symptoms and functional impairment were significant. Higher provider perception of TSC fit predicted improvements in selected patient outcomes.Conclusion: TSC can be delivered by CMHC providers trained by local CMHC trainers with strong outcomes. These data contribute to the dearth of evidence for TTT collected from locally trained providers and from patients treated by local CMHC trainers.Trial registration: Clinicaltrials.gov identifi er: NCT05805657. Registered on March 10, 2023. https://clinicaltrials.gov/ct2/show/NCT05805657.

    View details for DOI 10.21203/rs.3.rs-6414484/v1

    View details for PubMedID 40709255

  • The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer. Trials Callaway, C. A., Sarfan, L. D., Agnew, E. R., Dong, L., Spencer, J. M., Hache, R. E., Diaz, M., Howlett, S. A., Fisher, K. R., Yates, H. E., Stice, E., Kilbourne, A. M., Buysse, D. J., Harvey, A. G. 2023; 24 (1): 503

    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 outcomesand (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.

    View details for DOI 10.1186/s13063-023-07523-6

    View details for PubMedID 37550730

  • The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Behaviour research and therapy Callaway, C. A., Sarfan, L. D., Gumport, N. B., Harvey, A. G. 2023; 168: 104368

    Abstract

    The efficacy of modular evidence-based psychological treatments is promising, yet variation in module delivery is understudied. This study evaluated module delivery of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and its impact on patient outcomes. Adults (N=108) with serious mental illness and sleep and circadian dysfunction treated in a community setting were randomized to receive TranS-C plus usual care, or 6 months of usual care followed by delayed treatment with TranS-C. Data from both conditions were combined to maximize power. These secondary analyses tested whether the "dosage" of module delivery (defined as the proportion of total sessions in which a module was delivered) predicted treatment response, measured as functional impairment, psychiatric symptoms, sleep and circadian dysfunction, and sleep health, at post-treatment and 6-month follow-up. Higher dosages of seven modules were associated with improvement in the outcome variables (betas=-0.11-0.44; ps=0.000-0.030). Higher dosages of three modules were associated with a worsening of one or two outcome variables (betas=0.22-0.29; ps=0.001-0.043). Higher dosages of the remaining modules were not associated with outcomes. Although more evidence is needed, it may be wise to consider focusing provider trainings on ensuring fidelity to certain modules, given limited training time in community settings. ClinicalTrials.gov Identifier: NCT02469233, registered June 9, 2015.

    View details for DOI 10.1016/j.brat.2023.104368

    View details for PubMedID 37478529

  • 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. Research square Callaway, C. A., Sarfan, L. D., Agnew, E. R., Dong, L., Spencer, J. M., Hache, R. E., Diaz, M., Howlett, S. A., Fisher, K. R., Yates, H. E., Stice, E., Kilbourne, A. M., Buysse, D. J., Harvey, A. G. 2023

    Abstract

    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.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.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.Clinicaltrials.gov identifier: NCT05805657. Registered on April 10, 2023. https://clinicaltrials.gov/ct2/show/NCT05805657.

    View details for DOI 10.21203/rs.3.rs-2943787/v1

    View details for PubMedID 37398014

    View details for PubMedCentralID PMC10312945