"So Many Other Things Improve" with Transdiagnostic Treatment for Sleep and Circadian Problems: Interviews with Community Providers on Treating Clients with Serious Mental Illness.

Community mental health centers (CMHCs) offer invaluable, publicly-funded treatment for serious mental illness (SMI). Unfortunately, evidence-based psychological treatments are often not delivered at CMHCs, in part due to implementation barriers, such as limited time, high caseloads, and complex clinical presentations. Transdiagnostic treatments may help address these barriers, because they allow providers to treat symptoms across multiple disorders concurrently. However, little research has investigated CMHC providers' experiences of delivering transdiagnostic treatments "on the ground," particularly for adults with SMI. Thus, the aim of the present study was to assess CMHC providers' perspectives on delivering a transdiagnostic treatment - the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) - to adults diagnosed with SMI. In the context of a larger parent trial, providers were randomized to deliver a standard version of TranS-C (Standard TranS-C) or a version adapted to the CMHC context (Adapted TranS-C). Twenty-five providers from the parent trial participated in a semi-structured interview (n = 10 Standard TranS-C; n = 15 from Adapted TranS-C). Responses were deductively and inductively coded to identify themes related to Proctor's taxonomy of implementation outcomes. Four novel "transdiagnostic take homes" were identified: (1) transdiagnostic targets, such as sleep, can be perceived as motivating and appropriate when treating SMI, (2) strategies to bolster client motivation/adherence and address a wider range of symptom severity may improve transdiagnostic treatments, (3) balancing feasibility with offering in-depth resources is an important challenge for transdiagnostic treatment development, and (4) adapting transdiagnostic treatments to the CMHC context may improve provider perceptions of implementation outcomes.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health: Comorbidity and use of modules under the microscope.

Sleep and circadian problems are intertwined with serious mental illness (SMI). Thus, optimizing treatments that target comorbid sleep and circadian problems and SMI is critical. Among adults with sleep and circadian problems and SMI, the present study conducted a secondary data analysis of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). TranS-C targets a range of sleep and circadian problems and SMI with 15 modules, seven of which are optional. In a 'real world' sample recruited from a community setting (N=121, 52.07% female, 42.97% African American or Black), we aimed to (1) elucidate patterns of sleep and circadian problems that met criteria for full diagnoses and subdiagnostic symptoms across (a) the full sample and (b) SMI diagnoses, and (2) determine whether TranS-C optional modules were delivered as intended based on participants' sleep and circadian problems. Results indicated that most participants (> 85.0%) had full diagnoses or subdiagnostic symptoms of two or more sleep and circadian problems. Further, participants exhibited heterogenous comorbidities between sleep and circadian problems and SMI diagnoses. Specifically, participants with a schizophrenia spectrum disorder (n=50), bipolar disorder (n=35), and major depressive disorder (n=26) exhibited 25, 24, and 21 patterns of sleep and circadian comorbidity, respectively. Notably, most participants with insomnia, hypersomnia, and an advanced or delayed circadian rhythm phase disorder did not receive the intended TranS-C optional modules designed to target these problems. Results underscore sleep and circadian and SMI diagnostic complexity in the community. Additionally, findings reveal discrepancies between intended and 'real-world' use of treatment modules. Future research investigating clinician decision-making-particularly when treating patients with comorbidities or using modularized treatments-is needed.

Bridging eating disorder symptoms and trait anxiety in patients with eating disorders: A network approach.

OBJECTIVE: Anxiety is thought to influence the development and maintenance of eating disorders (EDs). However, little is known about how, specifically, anxiety influences ED symptoms and vice versa. Network analysis identifies how symptoms within and across disorders are interconnected. In a network, central nodes (i.e., symptoms) have the strongest relations to other nodes and are thought to maintain psychopathology. Bridge nodes are symptoms in one diagnostic cluster that are strongly connected to symptoms in another diagnostic cluster and are thought to explain comorbidity. We identified central and bridge nodes in a network of ED symptoms and trait anxiety features. METHOD: We estimated a regularized partial correlation network in patients with mixed EDs (N = 296). ED symptoms were assessed with the Eating Disorder Examination-Questionnaire. Trait anxiety was assessed with the Trait subscale of the State-Trait Anxiety Inventory. Items to include in the network were selected with a statistical algorithm to ensure that all nodes represented unique constructs. Central and bridge nodes were identified with empirical calculations. RESULTS: Central ED nodes were dietary restraint, as well as overvaluation of and dissatisfaction with shape and weight. The central trait anxiety node was low feelings of satisfaction. The strongest ED bridge node was avoidance of social eating. The strongest trait anxiety bridge node was low self-confidence. DISCUSSION: Avoidance of social eating and low self-esteem may be routes through which EDs and trait anxiety are linked.

The mediating role of state maladaptive emotion regulation in the relation between social anxiety symptoms and self-evaluation bias.

Although social anxiety symptoms are robustly linked to biased self-evaluations across time, the mechanisms of this relation remain unclear. The present study tested three maladaptive emotion regulation strategies - state post-event processing, state experiential avoidance, and state expressive suppression - as potential mediators of this relation. Undergraduate participants (N = 88; 61.4% Female) rated their social skill in an impromptu conversation task and then returned to the laboratory approximately two days later to evaluate their social skill in the conversation again. Consistent with expectations, state post-event processing and state experiential avoidance mediated the relation between social anxiety symptoms and worsening self-evaluations of social skill (controlling for research assistant evaluations), particularly for positive qualities (e.g. appeared confident, demonstrated social skill). State expressive suppression did not mediate the relation between social anxiety symptoms and changes in self-evaluation bias across time. These findings highlight the role that spontaneous, state experiential avoidance and state post-event processing may play in the relation between social anxiety symptoms and worsening self-evaluation biases of social skill across time.

Examining the Relation Between Adolescent Social Anxiety and Positive Affect Regulation: Self-Report vs. Observation.

Social anxiety symptomatology is associated with disruptions in positive affect, though no study has examined deficits in responses to positive affect related to adolescent social anxiety symptoms. The present study tested whether adolescents' self-reported and observed social anxiety symptoms were uniquely associated with specific responses to positive affect. Moreover, we examined whether adolescent gender moderated these relations. Ninety adolescents (ages 11 to 18, Mage = 14.26, SD = 2.03; girls = 62%; white = 79%) completed self-report measures, participated in a social stressor task, and engaged in two positively-valenced interaction tasks with their female caregivers. Adolescent self-reported social anxiety symptoms were not uniquely associated with responses to positive affect. However, observed social anxiety symptoms were uniquely related to greater self-reported inhibiting positive affect responses and fewer observed positive affect maximizing behaviors. These findings highlight the need to examine self-reported and observed social anxiety symptoms in understanding associated disruptions in positive affect regulation.

State of the Science: The Transdiagnostic Intervention for Sleep and Circadian Dysfunction.

The transdiagnostic intervention for sleep and circadian dysfunction (TranS-C) was developed to provide one protocol that treats a range of sleep and circadian problems across a range of mental disorders. The focus of TranS-C includes, and goes beyond, categorically defined sleep and circadian disorders to facilitate healthy sleep along empirically derived "sleep health" dimensions. In this State of the Science review, we highlight key advantages of a transdiagnostic approach to sleep and circadian problems, including (a) the potential to better understand and treat comorbidity between various sleep and circadian problems and mental disorders, as well as the potential to better understand and treat the heterogeneous sleep and circadian problems that are present within a specific mental disorder; (b) the opportunity to explore the hypothesis that sleep and circadian problems are an important transdiagnostic mechanism in the multifactorial maintenance of mental disorders; (c) the potential to transfer breakthroughs made across siloed areas of research and practice; (d) its suitability for dissemination into a broad range of settings, particularly lower resource settings; and (e) the opportunity to improve a range of important outcomes. We also explain the theoretical underpinnings of TranS-C, including the two-process model of sleep regulation and the Sleep Health Framework. TranS-C includes cognitive-behavioral therapy for insomnia (CBT-I) and we offer recommendations for when to use CBT-I versus TranS-C. The process for developing TranS-C is discussed along with outcome data, applications to underserved communities, and future directions for research.

Transdiagnostic Sleep and Circadian Intervention in Youth: Long-term Follow-up of a Randomized Controlled Trial.

OBJECTIVE: This preregistered study compared the effects of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) with psychoeducation (PE) about sleep, health, yoga, meditation, and outdoor appreciation activities on sleep and circadian functioning, health risk, and sleep health behaviors at long-term follow-up (LTFU), an average of 8 years following treatment. We also examined if more sleep health behaviors at LTFU were associated with better sleep and circadian functioning at LTFU and if better sleep and circadian functioning were associated with lower health risk at LTFU. METHOD: At baseline, we randomly assigned adolescents with an eveningness chronotype to TranS-C (n = 89) or PE (n = 87). Of this sample, we assessed 106 young adults (mean age at follow-up = 22.5 years; n = 55 from TranS-C; n = 51 from PE) an average of 8 years following treatment. RESULTS: Despite TranS-C (vs PE) sustaining improvement in circadian functioning through 12-month follow-up, at LTFU, there were no significant differences between the conditions on any outcome, including sleep and circadian functioning, risks in 5 health domains indexed by self-report and ecological momentary assessment, sleep health behaviors, and physical measurements. Across both conditions, measures indicating poorer sleep and circadian functioning were associated with higher health risk across multiple domains, and more sleep health behaviors were associated with lower levels of eveningness at LTFU. CONCLUSION: These results provide an important window into the influence of development on long-term outcomes for youth and raise the possibility that interventions for youth could be enhanced with a focus on habit formation. CLINICAL TRIAL REGISTRATION INFORMATION: Maintaining Behavior Change: A 6-Year Follow-up of Adolescent 'Night-owls'; https://www. CLINICALTRIALS: gov/; NCT05098782. STUDY PREREGISTRATION INFORMATION: Long-term Follow-up of Young Adults Who Received TranS-C to Modify Eveningness Chronotype in Adolescence; https://osf.io/; d5a4g. DIVERSITY & INCLUSION STATEMENT: We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. We worked to ensure sex and gender balance in the recruitment of human participants. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper self-identifies as living with a disability. One or more of the authors of this paper received support from a program designed to increase minority representation in science.

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.

Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcomes? Study protocol for a randomized controlled trial.

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.

Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia.

OBJECTIVE: Treatments that alleviate insomnia over the long term are critical. We evaluated the relative long-term efficacy of cognitive therapy (CT), behavior therapy (BT), and cognitive behavior therapy (CBT) for insomnia. METHOD: Patients (N = 188, 62.2% female, 81.1% White, 6.5% Hispanic or Latinx, Mage = 47.4 years) with insomnia were randomized to eight sessions of CT, BT, or CBT for insomnia. Assessments at pretreatment and 12-month follow-up measured insomnia severity, insomnia response/remission, sleep diary parameters, and daytime functioning. RESULTS: Patients in all three treatment groups improved on insomnia severity, sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, work and social adjustment, and mental health (ps < .05). Moreover, in each treatment group, a substantial proportion of patients achieved remission and response. CBT was associated with larger improvements in insomnia severity relative to CT as well as greater remission and improvements in physical health, relative to CT and BT (ps < .05). For patients with a psychiatric comorbidity, CBT was associated with greater improvements in work and social adjustment and mental health, relative to CT (ps < 0.05). CT was not associated with change in time in bed, and none of the treatment conditions were associated with change in daytime fatigue (ps > .05). CONCLUSIONS: These encouraging results suggest that therapists may be able to offer CBT, BT, or CT to improve nighttime and daytime symptoms of insomnia over the long-term, with CBT offering a relative advantage for select outcomes and subgroups. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C).

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 (ßs = -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 (ßs = 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.

Cognitive Therapy-as-Usual versus Cognitive Therapy plus the Memory Support Intervention for adults with depression: 12-month outcomes and opportunities for improved efficacy in a secondary analysis of a randomized controlled trial.

OBJECTIVE: Patient memory for treatment is emerging as an important transdiagnostic mechanism of treatment outcomes. However, patient memory for treatment is limited. The Memory Support Intervention was developed to improve patient memory for treatment and thereby strengthen treatment outcomes. In this secondary analysis, the primary, preregistered aim was to test the 12-month follow-up outcomes of the Memory Support Intervention when used with cognitive therapy (CT + MS) for major depressive disorder, relative to CT-as-usual. The secondary, exploratory aim was to investigate opportunities to improve efficacy of the Memory Support Intervention. METHOD: Adults (N = 178) with major depressive disorder were randomized to CT-as-usual or CT + MS. Therapist use of memory support and patient memory for treatment, depression symptoms, and overall functioning were measured in blind assessments. RESULTS: Findings did not support differences between treatment conditions at 12-month follow-up. Therapists used memory support strategies with a narrow subset of treatment contents, and similarly, patients recalled a narrow subset of treatment contents. CONCLUSIONS: The findings highlight ways to strengthen the efficacy of the Memory Support Intervention, such as applying memory support strategies across a wider variety of treatment contents, which in turn, may boost patient recall and outcomes.

Optimizing outcomes, mechanisms, and recall of Cognitive Therapy for depression: Dose of constructive memory support strategies.

OBJECTIVE: Poor memory for treatment is associated with worse patient outcomes. Therapist use of constructive memory support strategies, which help patients actively engage with treatment content, may improve patient memory for treatment. We sought to identify the dose of constructive memory support needed to optimize treatment outcomes, mechanisms, and patient recall. METHOD: Adults with major depressive disorder (N = 178, mean age = 37.9, 63% female, 17% Hispanic or Latino/a) were randomized to Cognitive Therapy plus a Memory Support Intervention or Cognitive Therapy as usual. Because therapists from both groups used constructive memory support, treatment conditions were combined to maximize data. Depression and overall impairment were assessed before treatment, immediately post-treatment (POST), and six (6FU) and 12 months (12FU) after treatment. Patients completed measures of treatment mechanisms - utilization/competency in Cognitive Therapy skills - and treatment recall at POST, 6FU, and 12FU. Patient adherence to treatment was averaged across sessions. RESULTS: Using Kaplan-Meier Survival Analyses, the optimal dose of constructive memory support was eight uses per session (sensitivity analysis range: 5-12 uses). Pre-treatment depression symptoms and patient perceptions of treatment may impact the optimal dose. CONCLUSION: Eight uses of constructive memory support by therapists per session may optimize treatment outcomes, mechanisms, and recall over the long-term.

Serial Mediators of Memory Support Strategies Used With Cognitive Therapy for Depression: Improving Outcomes Through Patient Adherence and Treatment Skills.

Patient memory for treatment is poor. Memory support strategies can be integrated within evidence-based psychological treatments to improve patient memory for treatment, and thereby enhance patient outcomes. The present study evaluated possible mechanisms of these memory support strategies. Specifically, we tested whether therapist use of memory support strategies indirectly predicts improved patient outcomes via serial improvements in (a) patient adherence throughout treatment and (b) patient utilization and competency of treatment skills. Adults with major depressive disorder (N = 178, mean age = 37.93, 63% female, 17% Hispanic or Latino) were randomized to Cognitive Therapy plus a Memory Support Intervention or Cognitive Therapy-as-usual. Because therapists from both treatment groups used memory support strategies, data from conditions were combined. Blind assessments of depression severity and overall impairment were conducted before treatment, immediately posttreatment (POST), at 6-month follow-up (6FU), and at 12-month follow-up (12FU). Patient adherence to treatment was rated by therapists and averaged across treatment sessions. Patients completed measures of treatment mechanisms-namely, utilization and competency in cognitive therapy skills-at POST, 6FU, and 12FU. Results of serial mediation models indicated that more therapist use of memory support predicted lower depression severity at POST, 6FU, and 12FU indirectly and sequentially through (a) increased patient adherence during treatment and (b) more utilization and competency of Cognitive Therapy skills at POST, 6FU, and 12FU. The same patterns were found for serial mediation models predicting lower overall impairment at POST, 6FU, and 12FU. Together, boosting memory for treatment may represent a promising means to enhance pantreatment mechanisms (i.e., adherence and treatment skills) as well as patient outcomes.

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.

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.

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 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.

Outcomes From the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for Midlife and Older Adults With Serious Mental Illness and Sleep and Circadian Dysfunction.

The present study tested outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) among midlife and older adults with serious mental illness (SMI). Further, we tested predictors-credibility, expectancy, usefulness, and utilization-that may affect TranS-C outcomes. Midlife and older participants from a community setting (>49 years, 62.3% female, 37.7% African American or Black) with sleep and circadian problems and SMI were randomized to receive TranS-C plus usual care (TranS-C+UC, n = 27) or usual care followed by delayed treatment with TranS-C (UC-DT, n = 26). Immediate and delayed TranS-C data were combined to increase power (combined n = 52). Outcomes were assessed at pretreatment, posttreatment, and 6-month follow-up. Credibility and expectancy were assessed during the second session. Usefulness and utilization of TranS-C skills were assessed at posttreatment and 6-month follow-up. TranS-C+UC, relative to UC-DT, was associated with improvements in depression symptoms, sleep disturbance, overall sleep health, and select sleep/wake outcomes, though not all improvements were sustained at 6-month follow-up. Lower usefulness of TranS-C skills predicted more severe sleep disturbance at posttreatment and daytime sleep-related impairment at posttreatment and 6-month follow-up. Lower utilization predicted more severe psychiatric symptoms at posttreatment, sleep disturbance at posttreatment and 6-month follow-up, and overall impairment and daytime sleep-related impairment at 6-month follow-up. Higher credibility and expectancy predicted greater usefulness of TranS-C skills at posttreatment and 6-month follow-up and greater utilization at 6-month follow-up. Together, findings highlight benefits of TranS-C for midlife and older adults with SMI. However, boosting credibility, expectancy, utilization, and usefulness may meaningfully improve TranS-C outcomes.

Outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in a community setting: Unpacking comorbidity.

OBJECTIVE: Comorbidity and subdiagnostic symptoms are understudied for sleep and circadian problems. We evaluated 1) impairment associated with (a) number of sleep and circadian problems and (b) diagnostic threshold (full diagnosis vs. subdiagnostic symptoms), and 2) Transdiagnostic Sleep and Circadian Intervention (TranS-C) outcomes for participants with specific sleep and circadian problems. METHOD: Community participants (N = 121) with serious mental illness and sleep and circadian problem(s) were randomized to receive TranS-C plus usual care (TranS-C + UC) or usual care plus delayed TranS-C (UC-DT). Overall impairment, psychiatric symptoms, and sleep and circadian dysfunction were assessed at pre-treatment, post-treatment, and 6-month follow-up. RESULTS: Higher numbers of sleep and circadian problems, versus one problem, were associated with worse overall impairment, psychiatric symptoms, and sleep and circadian dysfunction (ps < 0.05, ω2 = 0.06-0.15). Diagnostic threshold was not associated with baseline functioning (ps > 0.05). TranS-C + UC versus UC-DT was associated with psychosocial and sleep and circadian improvements for specific sleep and circadian problems (insomnia, hypersomnia, parasomnias, periodic limb movement/restless leg syndrome, circadian rhythm disorders), though improvements varied by problem. TranS-C + UC outcomes were not moderated by number of sleep and circadian problems (ps > 0.05). CONCLUSION: Higher numbers of sleep and circadian problems, not diagnostic threshold, were associated with greater impairment. Transdiagnostic utility of TranS-C + UC was supported.