This study was preregistered on clinicaltrials.gov (identifier: NCT05805657) and received approval from the Committee for the Protection of Human Subjects at the University of California, Berkeley. Any protocol changes will be submitted to clinicaltrials.gov and the Committee for the Protection of Human Subjects. The research team will communicate relevant changes to the CMHCs and in appropriate publications (e.g., see subsection on Changes to Preregistration below). If there are too many findings to reasonably interpret in one paper, we may separate some of the findings into two or more papers. This research is funded by the National Institute of Mental Health (R01MH120147). The present protocol used the SPIRIT reporting guidelines (50) (see SPIRIT checklist in supplemental documents and Table 2).
Train-the-Trainer
Throughout Phases 1 (Implementation Phase) and 2 (Train-the-Trainer Phase), implementation is conducted via facilitation (51). Specifically, each CMHC receives direct support from a lead facilitator, who is a licensed clinical social worker with expertise in community mental health and sleep treatment (ERA), and a team of trained facilitators employed by the research team. Facilitation is based on the REP framework(38) and was selected as the core implementation strategy used to implement TranS-C in the CMHCs, based on promising evidence (52–54). The UC Berkeley facilitation team transitioned CMHC sites to the Train-the-Trainer Phase on a rolling basis. Each site’s readiness for TTT was assessed by the level of provider engagement, the number of patients who had completed sleep treatment, and the supportiveness of leadership. The first site was transitioned to TTT in December 2020, and all sites were transitioned by December 2022. Treatment recruitment will continue through 2023.
In the Train-the-Trainer Phase, the facilitators’ primary activities are (1) recruiting, training, and providing consultation for local trainers and (2) recruiting and enrolling Generation 2 providers and patients. While local trainers were heavily involved in increasing provider adoption and utilization of TranS-C, the facilitators remained in charge of recruiting and enrolling providers and patients through the formal study procedures (e.g., consent, assessments) to reduce burden. Facilitators also hold as-needed consultation for TranS-C providers across generations, offer certification in sleep treatment and sleep training, process Continuing Education credits, and organize regular meetings with CMHC leadership to provide ongoing support and problem-solve barriers in implementing TranS-C. After local trainers hold their first training, the facilitation team gradually transfers select responsibilities to them (e.g., presentations to CMHC providers on advanced sleep-related topics; supervising TranS-C cases on the path to certification), all of which are noted in the ‘Generation 2’ and ‘Recruitment’ sections below. In other words, the role of facilitators shifted from full facilitation (51) toward technical assistance (37) as local trainers gained mastery and independence. A gradual approach was selected to enable facilitators to provide sufficient modeling, support, and feedback for local trainers and transfer responsibility at a pace that felt manageable for them.
Training Local Trainers
Local trainers consist of Generation 1 providers who were trained to deliver TranS-C by the lead facilitator, who is also the ‘expert trainer,’ during the Implementation Phase (43). To train Generation 1 providers to be local trainers, the expert trainer first led a 30-minute welcome meeting to provide an overview of the process and offer training in public speaking. Next, the TranS-C training material was condensed into ‘big picture’ concepts and the content was divided into one-hour chunks. The expert trainer then conducted “booster trainings” for local trainers to review each content chunk (4–5 boosters for Adapted TranS-C, 6–7 boosters for Standard TranS-C). Before each booster training and to facilitate active learning, the expert trainer assigned each local trainer a selection of slides to present. The expert trainer also provided materials to support the trainer to prepare (e.g., a video recording of the expert trainer presenting the same material, a written overview synthesizing the big picture concepts for that booster). In between booster trainings, the expert trainer offered 30–60 minute 1-on-1 consultations for each trainee to (1) answer questions, (2) allow the local trainer to practice their slides for the upcoming booster, (3) provide individualized feedback on the local trainers’ presentation style, and (4) offer positive reinforcement and praise to increase confidence. Local trainers also received feedback during booster trainings from the expert trainer and their peers. All local trainers were deemed adequately prepared to move forward to lead their first training after actively participating in and completing all booster trainings.
Generation 2
Local trainers lead Generation 2 trainings independent of the expert trainer. For the first training led by each local trainer, a UC Berkeley facilitator attends to provide support with Zoom technology. The facilitator only answers content-related questions if requested by the local trainer. After the first training, facilitator support is offered but not required. Following conducting their first training, local trainers begin holding drop-in supervision hours to Generation 2 providers. Note, some local trainers preferred to hold regular supervision hours whereas others preferred to offer supervision on an as-needed basis, depending on trainers’ preference and scheduling capacity. Accordingly, local trainers also take on the responsibility of supervising cases on the path to TranS-C certification. Note, UC Berkeley facilitators continue to review submitted case materials and approve certifications. The expert trainer continues to hold drop-in consultation hours, open to both Generation 1 and 2 providers, and also holds individual consultation for the local trainers to support their transition to a supervision role. During consultation for local trainers, the expert trainer clarifies advanced TranS-C content, consults on challenging TranS-C cases, and reinforces evidence-based supervision techniques. Additionally, the UC Berkeley facilitators host monthly ‘sleep expert network meetings’ with all engaged local trainers, providing an informal opportunity for local trainers to learn from their new colleagues, build community, and discuss strategies to boost engagement in TranS-C among providers.
Participants
Participants in the present study are drawn from CMHCs and consist of local trainers, Generation 2 providers, and Generation 2 patients[1]. All participants are blind to condition (Standard vs. Adapted TranS-C), though are not blind to patient treatment allocation (immediate vs. delayed).
All CMHC sites from the Implementation Phase were invited to participate in the TTT Phase. The inclusion criteria for selecting the CMHC sites for the Implementation Phase were: 1) provision of publicly funded adult mental health outpatient services and 2) support from CMHC leadership.
The inclusion criteria for local trainers were: 1) employed in participating CMHCs; 2) completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers); and 3) volunteer to participate and formally consent to participate. In reality, most trainers had completed their TranS-C certification, including completing TranS-C with three patients or were actively delivering TranS-C to patients and progressing towards TranS-C certification (43).
CMHCs determined eligibility for Generation 2 providers (e.g., case managers, nurses, psychiatrists, training department staff), because this mirrors their real-world practice of determining who acquires additional training. For some CMHCs, this involves mandating TranS-C training for all untrained staff, whereas in others, leadership advertises the opportunity and allows anyone who is interested to register. The other inclusion criteria for Generation 2 providers are: 1) employed or able to deliver patient-facing services to patients within the CMHC; 2) interest in learning and delivering TranS-C; and 3) volunteer to participate and formally consent to participate.
The inclusion criteria for patients are: 1) aged 18 years and older; 2) meet criteria for an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team; 3) exhibit a sleep or circadian disturbance as determined by endorsing 4 (quite a bit) or 5 (very much), or the equivalent for reverse scored items, on one or more PROMIS-Sleep Disturbance questions (55, 56); 4) guaranteed place to sleep for at least two months that is not a shelter; 5) receiving the standard of care for the SMI and consent to regular communications between the research team and provider; and 6) consent to access their medical record and participate in assessments.
Patients will be excluded if they meet any of the following criteria: 1) presence of an active and progressive physical illness or neurological degenerative disease that is directly related to the onset and course of the sleep and circadian problems, or making participation in the study unfeasible, as assessed by the Checklist of Medical Conditions and Symptoms on the Duke Structured Interview for Sleep Disorders (57) and clinical interview; 2) presence of substance abuse/dependence only if it makes participation in the study unfeasible; 3) current active intent or plan to commit suicide (those with suicidal ideation are eligible) only if it makes participation in the study unfeasible, or homicide risk; 4) night shift work for more than two nights per week in the past three months (i.e., regularly scheduled work from 12 a.m. – 6 a.m.); or 5) pregnant or breastfeeding.
Recruitment
Community Mental Health Centers
Building the CMHC network that forms the basis for this study began in August 2013 with outreach by the Principal Investigator (AGH). Originally, eight counties—each generally consisting of three to 10 CMHC sites—agreed to participate in the Implementation Phase. At various stages of the study, we have continued to focus on recruiting new counties and new CMHC sites to maximize provider and patient sample size goals for the Implementation and Train-the-Trainer Phases. For instance, all counties who participated in the Implementation Phase were invited to participate in the Train-the-Trainer Phase. Most elected to continue participating in the Train-the-Trainer Phase, with the exception of one county. Thus, to account for the latter, another county (Lake County) was recruited for the Train-the-Trainer Phase. Sites in the following nine counties in California, United States are currently participating in the Train-the-Trainer Phase: Alameda, Contra Costa, Kings, Monterey, Placer, Santa Cruz, Solano, Santa Clara, and Lake. Note that sites in San Luis Obispo are also participating but are operating as part of Monterey County.
Local Trainers
The UC Berkeley facilitation team works collaboratively with CMHC leadership, management, and champions (i.e., providers actively engaged and spearheading the TranS-C program in CMHCs) to identify and approach potential local trainers for participation. Benefits of becoming a trainer are emphasized, including certification as a TranS-C trainer, free training in teaching and supervision techniques, and career development opportunities.
Generation 2 Providers
Generation 2 provider recruitment is a joint effort by UC Berkeley facilitators, CMHC leadership, and local trainers. UC Berkeley facilitators meet with key CMHC leadership, who help to engage and recruit Generation 2 providers in their CMHC. Facilitators encouraged local trainers to engage and recruit Generation 2 providers by describing the benefits of participating in the study during their TranS-C trainings. These benefits include: possible improvement in sleep and mental health for patients, certification in TranS-C for providers, expert consultation from the UC Berkeley research team, hard copies of the treatment materials, enrollment prizes, and financial compensation received by participating patients. After TranS-C trainings, local trainers send weekly emails for one month that highlight each of these benefits and present other resources related to TranS-C, sleep, and mental health. Providers are also recruited through flyers posted in CMHCs, announcements at staff meetings, meetings organized by the facilitators, and appointments by leadership. Strategies to maintain relationships with providers and optimize data collection are ongoing by facilitators, including workshops and trainings, “enrollment challenges” and prizes (e.g., treatment-related books, magnets, t-shirts, mugs, and gift cards), continuing education credits for participation, and distributing newsletters or other topical resources. UC Berkeley facilitators encouraged local trainers to take part in or lead these efforts whenever possible.
Generation 2 Patients
Patients for Generation 2 providers are recruited through a variety of methods, based on each CMHC’s preference. These methods include the following: (1) posting fliers from the research team in waiting rooms and providers’ offices; (2) integrating a sleep screener into intake paperwork; (3) asking providers to screen patients on their caseload; and (4) encouraging word of mouth between patients. Potentially eligible patients are typically identified by their providers. With the patient’s consent, the provider contacts the facilitators, who connect the patient with the assessment team so that the patient can be formally evaluated for eligibility and enrolled in the study. After eligibility has been confirmed and consent to participate in the study has been given, the patient is matched to a CMHC TranS-C provider. Ideally, the TranS-C provider is the patient’s own provider (e.g., their case manager, nurse, physician). If this is not possible, an alternative provider is identified. Patient retention is maximized via collaborative efforts between the providers, facilitators, local trainers (e.g., via supervision), and the assessment team. Considerable efforts are made by the facilitators and assessors to answer questions and troubleshoot challenges (e.g., scheduling difficulties) to prevent attrition.
Interventions
As described above, two variations of TranS-C are tested in this trial: Standard TranS-C and Adapted TranS-C. Both are delivered alongside the usual care offered by each CMHC. The control condition is usual care followed by delayed treatment with Adapted or Standard TranS-C (UC-DT). In the CMHCs, usual care consists of working with a service provider (e.g., psychologist, case manager, occupational therapist, psychiatrist, nurse practitioner) who provides direct mental health support from within their scope of practice. The patient might also be referred by that provider for other services as needed (e.g., healthcare, housing support, nutrition, vocational specialists, or peer advocacy). Occasionally patients receive treatment from interdisciplinary or residential teams, meaning their services are coordinated across multiple service providers. Although most providers deliver TranS-C via individual sessions, some choose to deliver it in a group setting. Note that TranS-C was originally developed in English, then translated into Spanish about four months into data collection to expand access. The Spanish translation of TranS-C was subsequently offered by Spanish-speaking providers. The treatment conditions, along with the adaptation process for Adapted TranS-C, are described below. The modules that make up Standard and Adapted TranS-C are compared in Table 1 and described in detail in Sarfan et al. (2023). While the ordering of modules is broadly suggestive of the order of completion, Generation 2 providers are trained to be sensitive to the differences between patients as to which processes are key to maintaining their distress and to address these processes at an earlier stage of treatment.
Table 1
TranS-C Modules – Standard and Adapted
Cross-Cutting Modules | Treatment Modules | Standard Module (Adapted) |
Functional Analysis* | Education* | Motivational Enhancement* | Goal Setting* | Regular Sleep-Wake Times* | Core Module 1a (Core Module 1) |
Wind-down Routine* | Core Module 1b (Core Module 2) |
Wake-up Routine* | Core Module 1c (Core Module 3) |
Improving Daytime Functioning* | Core Module 2 (Core Module 4a) |
Unhelpful Beliefs about Sleep | Core Module 3 |
Improving Sleep Efficiency | Optional Module 1 |
Reducing Time in Bed | Optional Module 2 |
Delayed or Advanced Phase | Optional Module 3 |
Reducing Sleep-Related Worry* | Optional Module 4 (Optional Module) |
CPAP Machine and Exposure | Optional Module 5 |
Negotiating Complicated Environments | Optional Module 6 |
Reducing Nightmares | Optional Module 7 |
Maintaining Your Gains* | Core Module 4 (Core Module 4b) |
Note. *modules included in Adapted TranS-C |
Table 2
SPIRIT Depiction of Timing and Measures Collected for Train-the-Trainer Phase
| Screening | Post-Training | Pre-Treatment | Mid-Treatment | Weekly During Treatment | Post-Treatment† | 6-Months Post-Treatment |
Generation 2 Patient |
Sociodemographics | | | x | | | x | x |
Eligibility Items | x | | | | | | |
PROMIS-SDP | x | | x | x | | x | x |
PROMIS-SRI | | | x | | | x | x |
DSM-5 Cross-Cutting | | | x | | | x | x |
SDS | | | x | | | x | x |
Sleep Health Composite | | | x | | | x | x |
PHENX Toolkit | | | x | | | x | x |
CEQ | | | | | | x | |
Generation 2 Provider |
Sociodemographics | | x | | | | | |
Occupation | | x | | | | | |
AcceptabilityP | | x | | | | x | |
Appropriateness | | x | | | | x | |
Feasibility | | x | | | | x | |
Weekly Session Log | | | | | x | | |
Note. Allocation to Adapted or Standard TranS-C occurs at the county level and prior to enrollment of any participants in that county (i.e., patients or providers). Enrollment of patients and allocation to immediate TranS-C or delayed TranS-C (UC-DT) occur after the screening and before the pre-treatment assessment. Enrollment of providers occurs after the training; note: providers may hold a dual role as a local trainer. †Post-treatment assessments for immediate TranS-C and delayed TranS-C (UC-DT) were identical except that the CEQ was not delivered at the UC-DT post-treatment assessment. P = Primary Outcome. PROMIS-SD = PROMIS-Sleep Disturbance; note: PROMIS-SD is only assessed during the pre-treatment assessment if done more than one month after the screening to minimize burden for patients. PROMIS-SRI = PROMIS-Sleep Related Impairment. SDS = Sheehan Disability Scale. CEQ = Credibility/Expectancy Questionnaire. |
Standard TranS-C
Standard TranS-C is delivered in 8x50 minute weekly sessions and comprised of 4 cross-cutting modules featured in every session, 4 core modules, and 7 optional modules that are used based on clinical presentation, treatment goals, and provider case conceptualization (27). Training for providers in the Standard TranS-C condition consists of a 1-day workshop (i.e., 6–8 hours) or two, 3-hour training blocks.
Adapted TranS-C
Adapted TranS-C is delivered in 4x20 minute weekly sessions and comprised of the same four cross-cutting and core modules as in Standard TranS-C. Modifications include (1) the cross-cutting modules are standardized across sessions and scripted (to reduce preparation time) and (2) the core modules are split up into five (rather than four) modules. Additionally, there is one optional module which can be integrated with the core modules, based on clinical presentation, treatment goals, and provider case conceptualization. Training for the Adapted TranS-C condition consists of four, 1-hour workshops or two, 2-hour workshops, based on CMHC preferences.
There have been calls for rigorous approaches to treatment adaptation (58, 59). In response, we grounded the process for adapting TranS-C in theory, data, and stakeholder input. As the overarching guide for the adaptation process, the REP framework was used (38). See Sarfan et al. (2023) for a detailed description of the adaptation process for Adapted TranS-C. In sum, during Phase 1 of REP (Pre-Condition), we established that (a) there is a need for effective, feasible EBPTs for SMI in CMHCs, (b) sleep and circadian functioning may represent a powerful target to help address this need, and (c) there was empirical support for TranS-C in CMHCs (35) (see Introduction). Additionally, we gathered stakeholder input on fit and packaging of the intervention (36, 48). We also reviewed past data and identified the TranS-C treatment skills that were most utilized by patients with a utilization scale adapted from Gumport et al. (2019) (60). Next, we considered TranS-C’s theoretical underpinnings and mechanisms of action (27, 61) from which we retained the core elements (59, 62). After, we piloted Adapted TranS-C with 21 adults through the PI’s UC Berkeley research clinic (unpublished data). Informal feedback was solicited from providers and patients who participated in this pilot to further refine Adapted TranS-C. In Phase 2 of REP (Pre-Implementation), we customized the delivery of TranS-C training and treatment materials to the CMHC context based on the input from CMHC leadership, staff, and patients (36, 48). Throughout REP Phases 1 and 2, following leading adaptation frameworks, we sought to ensure that Adapted TranS-C would be relevant to the broadest range of patients and to account for factors that impact implementation (e.g., resources required) (59, 63, 64). The present trial will address the last two phases of REP – namely, Phases 3 (Implementation) and 4 (Maintenance and Evolution).
UC-DT
In UC-DT, patients begin with usual care for four weeks if their CMHC is randomized to Adapted TranS-C or eight weeks of usual care if their CMHC has been randomized to Standard TranS-C. After the delay, they receive Adapted or Standard TranS-C, also based on the condition to which their CMHC has been randomized (see Fig. 2). The decision to compare TranS-C to UC-DT was made in close collaboration with the early CMHC partners. This design aims to strike a balance between (a) including a comparison group to demonstrate the effectiveness of TranS-C in community settings; (b) ensuring that all participants receive what we hypothesize to be an active treatment (TranS-C); and (c) maximizing efficiency in terms of study duration, budget, and participants’ time investment. Notably, usual care has been the comparison group in several influential studies (65–67).
Measures
In addition to the measures below, a sociodemographics form is completed by providers and patients. Only measures that will be analyzed for the primary aims of the Train-the-Trainer Phase (see above) are reported below. See Table 2 for timing of each measure.
Generation 2 Providers
Primary Outcome
Acceptability. Generation 2 providers rate the acceptability of TranS-C via the Acceptability of Intervention Measure (68). This 4-item measure is rated on a scale from 1 (completely disagree) to 5 (completely agree). This measure has demonstrated satisfactory known-groups validity, internal reliability, test-retest reliability, and sensitivity to change (68).
Secondary Outcomes
Appropriateness and Feasibility. Generation 2 providers rate the appropriateness and feasibility of TranS-C via the following 4-item measures: Intervention Appropriateness Measure and Feasibility of Intervention Measure (68). Both measures are rated on a scale from 1 (completely disagree) to 5 (completely agree). These measures have demonstrated satisfactory known-groups validity, internal reliability, test-retest reliability, and sensitivity to change (68).
Other Measures
Weekly Session Log. To assess the number of sessions delivered to each enrolled patient by each Generation 2 provider, providers complete a weekly survey, in which they log each session for each client.
Occupation. Generation 2 providers are asked to report their current position, professional degree, and work history, including their caseload, theoretical orientation, licensure status, and previous training in sleep treatment.
Generation 2 Patients
Primary Outcome
Sleep Disturbance. The 8-item PROMIS-Sleep Disturbance (PROMIS-SD) assesses disruption to sleep (e.g., restlessness, trouble staying asleep) over the past seven days (55). Items are rated on a scale from 1 (not at all/never/very poor) to 5 (very much/always/very good), and scores range from 8–40, with higher scores indicating greater disturbance. This measure has demonstrated acceptable reliability and validity (55, 56).
Secondary Outcomes
Sleep-Related Impairment. The 16-item PROMIS-Sleep Related Impairment (PROMIS-SRI) assesses daytime impairment related to sleep problems over the past seven days on a scale from 1 (not at all/never) to 5 (very much/always) (55). Scores range from 16–80, with higher scores indicating greater impairment (e.g., daytime sleepiness, difficulty concentrating). This measure has demonstrated excellent psychometric properties (55, 56).
Functional Impairment. Functional impairment is assessed via the Sheehan Disability Scale (SDS) (69). Impairment in work and school, social life, and home and family is rated on a scale from 0 (not at all) to 10 (extremely). Scores range from 0–30, with higher scores indicating greater impairment. This measure has demonstrated good reliability and validity (69, 70).
Overall Sleep Health. The Sleep Health Composite is proposed to capture overall sleep health for the complexity of sleep problems in SMI that are covered by TranS-C (71). It is defined as the sum of scores on six sleep health dimensions (each dimension dichotomized as 1 = good; 0 = poor): Regularity (midpoint fluctuation), Timing (mean midpoint), Efficiency (sleep efficiency), Duration (total sleep time), Satisfaction (sleep quality question on PROMIS-SD), and Alertness (daytime sleepiness question on PROMIS-SRI). All dimensions – except Satisfaction and Alertness – are assessed via questions about sleep-wake patterns over the past seven days (e.g., In the past week, what time have you usually woken up in the morning?). Scores range from 0–6, with higher scores indicating better sleep health. Initial validity of this measure has been established (71).
Psychiatric Symptoms. The DSM-5 Cross-Cutting Measure assesses psychiatric symptoms across 13 mental health domains. Participants rate how often they were bothered by each symptom on a scale from 0 (not at all) to 4 (nearly every day). Scores range from 0–52, with higher scores indicating more severe symptoms. This measure has demonstrated good test-retest reliability and clinical utility (72, 73).
Exploratory Outcomes
PhenX Toolkit: Substance Use and Suicidality. Scales from the PhenX Toolkit (74) are used to assess various patient outcomes, including suicidal ideation and behaviors, alcohol, tobacco, and other psychoactive substances (e.g., cannabis, hallucinogens, sedatives, etc.). PhenX measures have been compiled by working groups and domain experts via a consensus process to facilitate consistency across studies (74). To assess suicidal ideation and behaviors, the PhenX ‘Classification of Suicidal Ideation and Suicidal Behavior - Adult - Current’ protocol is used. This protocol includes two subscales from the screening version of the Columbia-Suicide Severity Rating Scale: Severity of Suicidal Ideation and Suicidal Behavior, assessing suicidality during two time periods—namely ideation in the past month and suicidal behavior in the past three months. To ease patient burden, this measure was adapted slightly, such that if patients deny suicidal ideation, they are not required to answer questions about suicidal behavior. To assess alcohol, the PhenX ‘Alcohol − 30-Day Quantity and Frequency’ protocol is used. This protocol measures both quantity and frequency of alcohol consumption. To assess tobacco, the PhenX ‘Tobacco − 30-Day Quantity and Frequency - Adult' protocol is used. This measure has three sets of question protocols: (1) a protocol for ‘Every-Day Smokers,’ (2) a protocol for ‘Some-Day Smokers,’ and (3) a protocol for ‘Former Smokers.’ If patients report that they have never smoked tobacco, this measure is skipped. To assess use of substances and other drugs, the PhenX ‘Substances − 30-Day Frequency’ protocol is used. This measure assesses use of substances such as sedatives, painkillers, stimulants and hallucinogens. In addition, caffeine is assessed using questions adapted from the ‘Supplemental Beverage Questionnaire.’ Questions used in the present study assess frequency and quantity of caffeinated or decaffeinated drinks consumed over the past 30 days.
Credibility and Perceived Improvement. Perceptions of TranS-C credibility and perceived symptom improvement are assessed by four questions adapted from the Credibility/Expectancy Questionnaire (CEQ) (75). These questions assess (1) how logical TranS-C seemed, (2) how successful it was in reducing sleep symptoms, (3) how confident patients would be in recommending TranS-C to a friend, and (4) how much improvement patients believe had occurred. All questions are rated on a scale from 0 (not at all) to 9 (very), except for the final question (i.e., on perceived improvement), which is rated as a percentage from 0-100%.
Procedure
Providers and patients are consented by the assessment team prior to participation. Although we do not collect trainer-specific data from local trainers, note that all trainers were required to complete a Generation 1 training, after which they had provided consent to participate. All participants are informed that they can withdraw from the study at any time. All patients are compensated for their participation, and providers are compensated if permitted by their CMHC. Local trainers volunteered to become trainers and were not compensated, however a certification in TranS-C training and a mug were provided if the trainer trained a minimum of 15 people across at least two trainings and supervised a minimum of three TranS-C cases.
Generation 2 provider and patient assessments are completed by the assessment team, comprised of experienced assessors. Note that assessors complete the consent process to minimize burden on participants (e.g., this practice reduces number of calls from team). Because the assessors need to provide study-related information—such as number of assessments and treatment sessions—to the patients during the consent process, the assessors are not blind to condition at the pre-treatment assessment. However, at post-treatment and 6FU, we endeavor to keep assessors blind to condition. As is common in clinical trials, there are ways that assessors may be able to infer treatment condition (e.g., slightly different assessment batteries, patients may ask assessors “when does treatment start?” during the post-delay assessment). Assessors receive ongoing supervision and are thoroughly trained to deliver the surveys with integrity and minimal bias.
Local Trainers
Trainers do not complete assessment batteries. Note that some trainers are also TranS-C providers in Generation 1 and complete the corresponding provider assessments (i.e., for Phase 1: Implementation Phase) (43).
Generation 2 Providers
Provider assessments are completed after they complete TranS-C training, as well as at post-treatment. See Fig. 3 for provider timeline.
Generation 2 Patients
Patient assessments in the immediate TranS-C treatment conditions are completed at pre-treatment, mid-treatment, post-treatment, and six months after treatment (6FU). Patient assessments in the UC-DT condition are completed at pre-treatment and four or eight weeks after pre-treatment (i.e., post UC-DT), depending on whether their county has been randomized to Adapted or Standard TranS-C, respectively. After the post UC-DT assessment, patients start delayed treatment with TranS-C. They subsequently complete assessments at mid-treatment, post-treatment, and 6FU. Note that patients do not complete a 6FU assessment after the delayed portion of UC-DT. This was a compromise made with CMHC partners, so that patients would not need to wait 7–8 months to receive treatment. See Fig. 2 for patient timeline.
Allocation
CMHCs and patients are randomized through a computerized randomization sequence. We do not stratify during randomization at the CMHC level. When randomizing patients, we stratify for presence of psychosis or not (current), presence of substance use or not (current) and age (≥ 50 or not), as there is evidence these variables can impact sleep or treatment outcome (48, 76, 77). Only the facilitators, assessors, and research team (i.e., not CMHCs, local trainers, providers, or patients) are privy to which CMHCs and patients are allocated to which TranS-C treatment condition (Adapted versus Standard TranS-C). CMHC providers, local trainers, and patients know whether their patients have been randomized to receive the immediate or delayed treatment. The facilitator informs the local trainer once a patient can start having sessions, who then informs the provider. In the immediate condition, the provider is asked to begin sessions as soon as possible. In the delayed condition, the provider is asked to wait until after the patient has completed the post-delay assessment (i.e., approximately four weeks in the Adapted condition or eight weeks in the Standard condition).
Sample Size
In the conceptualization of this study, the sample size goals for the Implementation Phase and the TTT phase combined were 96 providers and 576 patients (including 20% for attrition). During the conduct of the Implementation Phase of the study, we realized the immense value to knowledge of both the Implementation Phase and the TTT phase separately. Thus, we re-conceptualized the two phases as separate contributions. The Implementation Phase sample size remained as originally derived to power the analyses (43). The sample size of the TTT was guided by real-world factors, particularly the timeframe and budget for the study as well as the number of Generation 1 providers who are interested in recruiting, training, and supervising other providers. Additionally, in some CMHCs, many providers participated in Generation 1, leaving fewer providers to participate in Generation 2.
By the end of the TTT Phase, we project based on current recruitment numbers that we will recruit 130 patients and 60 providers. Using these sample sizes in a cluster randomized trial design, minimum detectable effect sizes were calculated for Aims 1 and 2 using Stata (78) and Aim 3 using Schoemann et al.’s (2017) application. For Aim 1, small to moderate correlations between TranS-C (vs. UC-DT) and sleep outcomes (rs = .37-.39) and intraclass correlation (ICC) of 0.30 were estimated using data from a prior trial (35). The coefficient of variation of cluster size was estimated as 0.72, based on the anticipated ratio of standard deviation of cluster size to mean cluster size for CMHC patients (79). A two-sided alpha of 0.05 was used. Together, the minimum detectable effect size with a sample of 130 patients and 9 clusters was estimated at a large effect size of d = 0.94. We expect this effect size will be feasible to detect, given that a prior study with a similar aim and same primary outcome produced a similarly large effect size (d = 0.96) (35). For Aim 2, prior studies have reported high sensitivity to change and test-retest reliability between measures of fit (rs = .83-.85) (68). Based on the ICC estimated from similar prior provider-level studies (38, 80), the ICC was assumed to be 0.20. The coefficient of variation of cluster size was estimated as 0.75, based on the anticipated ratio of standard deviation of cluster size to mean cluster size for providers (79). A two-sided alpha of 0.05 was used. Together, the minimum detectable effect size with a sample of 60 providers and 9 clusters was estimated at a medium to large effect size of d = 0.70. Although few prior studies are available, one similar trial found a medium effect size (d = .53) (81). Because these estimates suggest we might be slightly underpowered for Aim 2, effect sizes will be considered in addition to p-values. For Aim 3, a Monte Carlo power analysis through Schoemann et al.’s (2017) application was conducted with 1,000 replications, 20,000 Monte Carlo draws per replication, and 95% confidence intervals (82). Drawing from prior research, medium correlations (r = 0.30) were assumed between the predictor (TranS-C condition) and mediators (acceptability, appropriateness, feasibility; (81) as well as mediators and outcomes (r = 0.50). Small correlations (r = .20) were assumed between the predictor and outcomes (83). The power detected for the indirect effects with a sample size of N = 60 providers (i.e., for the mediators) was 0.62. As with Aim 2, because we may be underpowered to detect statistical significance at alpha = 0.05, effect sizes will be considered in addition to p-values.
Data Management and Dissemination
All patient-identifiable data are saved by the assessment team on password-protected fillable PDFs on a secure password-protected and HIPAA-compliant website. On these PDFs, patients and providers are assigned identification numbers. Local trainers who entered the study as Generation 1 providers retain their original provider identification number. Local trainers who enter the study solely to be trainers are assigned an identification number. These identification numbers are then used to link anonymized data that is collected via password-protected Qualtrics. When collecting assessments, assessors call participants and enter the data into Qualtrics. Participants also have the option of entering their data directly into a participant-facing version of the surveys via a HIPAA-compliant version of Qualtrics. Participant-identifiable data is not shared with outside entities during or after the trial. A data management team supervised by the PI (AGH), biostatistician (LD), and postdoctoral scholar (LDS) is responsible for downloading, collating, and analyzing the data.
A Data Safety Monitoring Board has been formed to help prevent and manage adverse events. The board includes members with expertise in SMI, psychosocial treatments, and randomized controlled trials. Members are independent from the PI and competing interests. A report was made to the board bi-annually for the first year of the research of the Implementation Phase (Phase 1). Since then, it has shifted to annual reports. However, if safety issues arise, it will be changed to monthly meetings. Yearly reports are submitted to the Committee for the Protection of Human Subjects at UC Berkeley and National Institute of Mental Health (NIMH). Triyearly reports on recruitment are also submitted to the NIMH.
Outcomes specifically of interest to our partners are presented to CMHC leadership as part of the widely-used implementation strategy, audit and feedback (84). However, these interim analyses are used only for facilitation purposes and do not address the aims specified herein or by Sarfan et al (2023). Also, they do not influence research procedures in any way (e.g., to inform when to terminate the trial).
Results from the trial, as well as analysis code, will be shared via peer-reviewed publications, professional conference presentations, and meetings and newsletters to CMHCs, as relevant. Other than the authors and compliance with data-sharing agreements stipulated by the National Institutes of Health, no other entities have contractual agreements to access the final dataset. Deidentified data are submitted to the National Institute of Mental Health Data Archive twice per year, per the NIMH requirements.
Roles and Responsibilities
This trial is supervised by the PI (AGH), who manages the facilitation team, assessment team, and the data management team. The PI meets with members of each team regularly and as needed in addition to daily email communication. Within each team, there is at least one trained lead (ERA, KF, JMS, LD, LDS) who supervises the day-to-day activities of other team members. There is no coordinating center, trial steering committee, or Stakeholder and Public Involvement Group. The responsibilities of each team are detailed elsewhere in this protocol. In summary, the facilitators execute the implementation of TranS-C via numerous activities, including training and supervising local trainers. The assessment team is responsible for the informed consent process and conducting participant (i.e., provider and patient) evaluations. CMHC leadership and enrolled local trainers and providers work with the facilitation team to recruit additional trainers, providers, and/or patients. Generation 2 providers help to identify potentially eligible patients, who are then connected with the assessment team for formal eligibility evaluation.
Changes to Preregistration
Originally, all three phases of the trial were preregistered on clinicaltrials.gov on November 6, 2019 (identifier: NCT04154631). However, after much consideration, we decided to separate the three phases (i.e., Implementation, Train-The-Trainer, and Sustainment), in order to thoroughly investigate each phase, thereby maximizing research and partners’ resources, and contributing as much as possible to the field. Thus, on April 10, 2023, we created a separate clinicaltrials.gov registration page for the TTT Phase (identifier: NCT05805657). This new page contains the information about the TTT Phase from the original preregistration but more thoroughly articulates the aims, hypotheses, measures, and procedures for this phase. After preregistration of the TTT Phase, we made one additional change. Specifically, given that change from pre-treatment to mid-treatment is not a primary outcome for any measure in the present study, we moved change from pre-treatment to mid-treatment on the Acceptability of Intervention Measure and the PROMIS-Sleep Disturbance measure from the primary outcome section to the secondary outcome section on clinicaltrials.gov.