Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 2: Train-the-Trainer
Phase: NA
Conditions: Sleep Disorder, Circadian Dysregulation
Sponsor: University of California, Berkeley

1 
 
Title: 
Implementing and Sustaining a Sleep Treatment to 
Improve Community Mental Health Part 2: Train-the-
Trainer 
CPHS Number: 
2019-04-12091 (Date of 1st  approval: May 23, 2019) 
Clinicaltrials.gov Number: 
NCT05805657 (Date of 1st  release: April 10, 2023) 
ClinicalTrials.gov Amendment Release Dates 
Amendment 1 Date: 05/11/2023 
Amendment 2 Date: 05/08/2024 
Amendment 3 Date: 07/01/2024 
Amendment 4 Date: 07/29/2024 
 
 
 
 
Sponsor 
National Institute of Mental Health (Grant number: R01MH120147_P2) 
 
 
Study Principal Investigator 
Allison G. Harvey, Ph.D. Psychology Department, 2121 Berkeley Way, 3rd floor. University of 
California, Berkeley, CA 94720-1650. USA. email: aharvey@berkeley.edu 
 
 

2 
 
TABLE OF CONTENTS 
TABLE OF CONTENTS ................................................................................................................ 2 
ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................................ 4 
ABSTRACT .................................................................................................................................... 5 
Table 1. TranS-C Modules – Standard and Adapted ...................................................................... 6 
Table 2. SPIRIT Depiction of Timing and Measures Collected for Train-the-Trainer Phase ........ 7 
Figure 1. Train-the-Trainer Model .................................................................................................. 8 
Figure 2. Community Mental Health Center (CMHC) Randomization and Patient Timeline ....... 9 
Figure 3. Generation 2 Provider Timeline .................................................................................... 10 
1 BACKGROUND ....................................................................................................................... 11 
2 AIMS.......................................................................................................................................... 12 
3 METHODS ................................................................................................................................ 13 
3.1 Train-the-Trainer ................................................................................................................. 14 
3.1.1 Training Local Trainers ................................................................................................ 14 
3.1.2 Generation 2 ................................................................................................................. 15 
3.2 Participants .......................................................................................................................... 15 
3.3 Recruitment ......................................................................................................................... 16 
3.3.1 Community Mental Health Centers .............................................................................. 16 
3.3.2 Local Trainers ............................................................................................................... 16 
3.3.3 Generation 2 Providers ................................................................................................. 16 
3.3.4 Generation 2 Patients .................................................................................................... 17 
3.4 Interventions ........................................................................................................................ 17 
3.4.1 Standard TranS-C ......................................................................................................... 18 
3.4.2 Adapted TranS-C .......................................................................................................... 18 
3.4.3 UC-DT .......................................................................................................................... 18 
3.5 Measures.............................................................................................................................. 19 
3.5.1 Generation 2 Providers ................................................................................................. 19 
3.5.2 Generation 2 Patients .................................................................................................... 19 
3.6 Procedure ............................................................................................................................. 21 
3.6.1 Local Trainers ............................................................................................................... 21 
3.6.2 Generation 2 Providers ................................................................................................. 21 
3.6.3 Generation 2 Patients .................................................................................................... 21 
3.7 Allocation ............................................................................................................................ 22 
3.8 Sample Size ......................................................................................................................... 22 

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3.9 Data Management and Dissemination................................................................................. 23 
3.10 Roles and Responsibilities ................................................................................................ 23 
3.11 Changes to Preregistration ................................................................................................ 24 
4 PLANNED ANALYSES ........................................................................................................... 24 
4.1 Preliminary Analyses and Missing Data ............................................................................. 24 
4.2 Dropout................................................................................................................................ 25 
4.3 Aim 1: Effectiveness Outcomes of Standard or Adapted TranS-C versus UC-DT ............ 25 
4.4 Aim 2: Adapted TranS-C versus Standard TranS-C on Fit to CMHC Context .................. 25 
4.5 Aim 3: Fit as a Mediator of Treatment Condition and Patient Outcome ............................ 26 
4.6 Sensitivity Analyses ............................................................................................................ 26 
4.7 Exploratory Aim 1: Generation 1 Compared to Generation 2 on Patient Outcomes .......... 26 
4.8 Exploratory Aim 2: TranS-C Treatment Condition on PhenX Toolkit and Perceived 
Credibility and Improvement .................................................................................................... 26 
4.9 Exploratory Aim 3: Treatment Effects Moderated by Risk Factors ................................... 27 
5 DISCUSSION ............................................................................................................................ 27 
6 TRIAL STATUS ........................................................................................................................ 29 
7 DECLARATIONS ..................................................................................................................... 29 
7.1 Ethics approval and consent to participate .......................................................................... 29 
7.2 Consent for publication ....................................................................................................... 29 
7.3 Availability of data and materials ....................................................................................... 29 
7.4 Competing interests ............................................................................................................. 29 
7.5 Funding Agency and Sponsor ............................................................................................. 29 
7.6 Authors' contributions ......................................................................................................... 30 
7.7 Acknowledgements ............................................................................................................. 30 
REFERENCES ............................................................................................................................. 31 
 
 
 
 

4 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
CMHC 
 
Community mental health center 
EBPT  
 
Evidence-based psychological treatment 
ICC 
 
 
Intra-class correlation 
MLM  
 
Multi-level modeling 
PARiHS 
 
Promoting Action on Research Implementation in Health Services 
PI 
 
 
Principal investigator 
PROMIS-SD  
PROMIS-Sleep Disturbance 
PROMIS-SRI  
PROMIS-Sleep Related Impairment 
REP 
 
 
Replicating Effective Programs 
SMI 
 
 
Serious mental illness 
TTT 
 
 
Train-the-trainer 
TranS-C 
 
Transdiagnostic Intervention for Sleep and Circadian Dysfunction 
UC-DT 
 
Usual care followed by delayed treatment with TranS-C 
 
 

5 
 
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 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 
 
Keywords: Train-the-trainer, transdiagnostic, sleep, circadian, serious mental illness, 
implementation, sustainment, adaptation, community mental health 
 
 

6 
 
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 

7 
 
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. 
 
 
 

8 
 
Figure 1. Train-the-Trainer Model 
 
 
 
 
 
 
 
 
 
 
 
Generation 1 
Train-the-Trainer 
Generation 2 
UC Berkeley 
expert trainers 
train a subset of 
Generation 1 
providers in how 
to train others in 
TranS-C 
UC Berkeley 
expert 
trainers 
train CMHC 
providers in 
TranS-C 
Local trainers 
train the next 
cohort of CMHC 
providers in 
TranS-C 
Generation 1 
providers 
Local TranS-C 
trainers 
Generation 2 
providers 

9 
 
Figure 2. Community Mental Health Center (CMHC) Randomization and Patient Timeline 
 
Replicating 
Effective 
Programs 
Stages 1 and 2 
Established in the 
Implementation 
Phase 
Flow During 
Train-the-
Trainer Phase 
CMHC 
Randomized 
Standard 
Condition 
Adapted 
Condition 
Pre-
Treatment 
Assessment 
Pre-
Treatment 
Assessment 
UC-DT 
(4 weeks) 
Start 
TranS-C 
UC-DT 
(8 weeks) 
Start 
TranS-C 
Post UC-DT 
Assessment 
Mid-
Treatment 
Assessment    
Post-
Treatment 
Assessment 
6-Month 
Follow-Up 
Assessment 
Post UC-DT 
Assessment 
Mid-
Treatment 
Assessment    
Post-
Treatment 
Assessment 
6-Month 
Follow-Up 
Assessment 

10 
 
Figure 3. Generation 2 Provider Timeline 
 
 
 
 
 
 
 
 
 
 
 
 
TranS-C Training 
CMHC Randomized 
Begin Treatment 
Post-Training Assessment 
Mid-Treatment Assessment 
Post-Treatment Assessment 

11 
 
1 BACKGROUND 
 
Although there has been a proliferation in evidence-based psychological treatments (EBPTs), transfer to 
routine practice settings has been slow (1,2). The field of implementation science has taken strides to 
address a host of variables influencing the use of EBPTs in routine practice settings (e.g., organizational, 
fiscal, policy) (3). However, a remaining issue is that many providers, particularly in community mental 
health care, do not receive sufficient training in EBPTs (4–6). Moreover, when providers are trained in 
EBPTs, the methods used for training are not necessarily effective or sustainable (7,8). Thus, to expand 
access to EBPTs, an important next step is to develop and evaluate effective, scalable, and sustainable 
approaches to EBPT training in community settings.  
 
Review papers over the past two decades have converged on key training elements as essential features of 
EBPT trainings, namely: a workshop utilizing active learning strategies, a provider manual, and ongoing 
clinical supervision and/or consultation (7–10). However, there are significant barriers to widespread 
implementation of these multicomponent training initiatives in community settings, including insufficient 
time and funding, shortage of trainers and consultants, staff turnover, and staff resistance to changes in 
the status quo (11–14). Indeed, many sites that initially embraced EBPTs after training have not sustained 
the practice (15). Thus, the critical unanswered question is: how can these multicomponent trainings be 
cost-efficient, acceptable and sustainable in community settings so that the benefits of EBPTs remain 
available for the vulnerable populations they serve over the long-term? 
 
The present study seeks to examine one possible solution: namely, the train-the-trainer (TTT) approach. 
Also called a “pyramidal” or “cascading” model, TTT is theorized to be the most promising method of 
implementing, scaling up, and sustaining training efforts (8,9). TTT is a training structure with multiple 
levels, which we will call “Generations.” First, external “expert trainers” train an initial cohort of 
providers in a specific EBPT. These providers in the initial cohort are referred to as “Generation 1 
providers.”  Next, Generation 1 providers are offered additional training on how to train others in the 
EBPT and become “local trainers.” These local trainers then train the next cohort of providers within their 
organization, who are referred to as “Generation 2 providers.” Local trainers can train future cohorts of 
providers and/or trainers as needed in response to staff turnover and patient demand. TTT is theorized to 
(a) be more cost-effective long-term relative to the cost of repeated use of an external expert trainer, (b) 
reduce the impact of provider turnover on EBPT sustainability, and (c) foster an organizational climate 
and culture that will sustain the EBPT (11). 
 
A fundamental question that TTT studies seek to answer is “when the torch is passed, does the flame still 
burn?” (p. 726) (16). In other words, are key outcomes maintained after the transition from Generation 1 
to Generation 2? Importantly, results have been mixed with respect to this question when looking across 
TTT studies for a variety of populations, including post-traumatic stress disorder (17), substance use (18), 
autism spectrum disorder (19), and individuals at risk for eating disorders (20). Promisingly, many prior 
studies show no difference between generations on select outcomes, such as training effectiveness (21), 
provider competence (18,22,23), and patient outcomes (24). Moreover, in a recent study by Fitzsimmons-
Craft and colleagues (2021), there is an encouraging signal that TTT appears to sustain provider 
adherence and competence to the EBPT better than expert consultation (25). However, there is also 
evidence of a scale-up penalty (i.e., poorer outcomes) in Generation 2. Southam-Gerow et al. (2014) 
found poorer quality case materials were submitted by providers trained by local trainers compared to 
those of providers trained by national experts (22). In a recent study conducted by Brabson and colleagues 
(2021), providers trained in Generation 2 were less knowledgeable about the EBPT and less satisfied with 
the training compared to those trained in Generation 1 (11). However, it is important to note that research 
on TTT is still in its infancy. TTT studies tend to suffer from small sample sizes, brief or no follow-up 
periods, and lack of methodological rigor (8,9), and relatively few clinical populations have been 

12 
 
investigated. As TTT becomes more commonly used as an implementation and sustainment strategy, 
more research is needed to ascertain whether key implementation and EBPT outcomes are maintained 
after training and supervision responsibilities have been passed to locally embedded individuals in 
Generation 2 (and beyond).  
 
The present trial seeks to continue progressing knowledge in this domain in the context of a 
transdiagnostic EBPT for sleep and circadian dysfunction—the Transdiagnostic Intervention for Sleep 
and Circadian Dysfunction (TranS-C) —for serious mental illness (SMI) in community mental health 
centers (CMHCs) (27). TranS-C is a skills-based, psychosocial, and modular treatment that was 
developed in response to mounting evidence that sleep and circadian dysfunction is a transdiagnostic 
contributor to SMI (28–34). In an initial efficacy trial, in which university-based therapists delivered 
TranS-C to adult CMHC patients, the results were promising. Specifically, relative to usual care followed 
by delayed treatment with TranS-C (UC-DT), TranS-C was associated with improvements in sleep and 
circadian problems, functional impairment, and psychiatric symptoms (35). 
 
The present hybrid type 2 effectiveness-implementation trial takes two important strides forward to test 
TranS-C in CMHCs. First, we will test TranS-C delivered by Generation 2 CMHC providers who are 
trained and supervised within CMHCs via TTT. Second, we will test two versions of TranS-C: Standard 
TranS-C and Adapted TranS-C. In the initial efficacy trial, CMHC staff identified dose and complexity as 
barriers to implementing TranS-C (henceforth “Standard TranS-C”) (36). In response, guided by the 
Enhanced Replicating Effective Programs framework (REP) (37,38) our team developed a modified 
version of TranS-C—henceforth “Adapted TranS-C”—to improve fit with the CMHC context (see 
Method and Sarfan et al., 2023 for systematic development of Adapted TranS-C).  Importantly, fit 
predicts a host of implementation outcomes, including reach, treatment fidelity, and sustained use of 
treatments (39,40). Thus, another core focus of the present trial is to determine if “fit,” operationalized 
herein as provider perceptions of TranS-C acceptability, appropriateness, and feasibility, could be 
improved in the context of CMHCs. 
 
Following the National Institute of Health stage model (41), the present trial is conducted over the course 
of three phases to test TranS-C with CMHC providers. In the first phase, the Implementation Phase, we 
will test implementation and effectiveness outcomes of Standard and Adapted TranS-C with CMHC 
providers, who are trained by treatment experts (i.e., Generation 1 of TTT) (42). In the second phase, the 
Train-the-Trainer Phase and the focus of this protocol, we will test implementation and effectiveness 
outcomes of Standard and Adapted TranS-C with CMHC providers who are trained and supervised 
within CMHCs (i.e., Generation 2 of TTT). In the third phase, the Sustainment Phase, we will focus on 
sustainment outcomes (Sarfan et al., in preparation). Importantly, to the best of our knowledge, this is the 
first study to utilize a TTT approach for sleep treatment for adults with SMI in CMHCs, let alone using 
this approach with Standard and Adapted versions of a transdiagnostic treatment. Together, this trial 
builds upon recent efforts to tackle the complex challenge of sustaining transdiagnostic, modular 
treatment approaches in real-world settings (16). 
2 AIMS 
 
This study aims to evaluate the implementation and effectiveness outcomes of TranS-C in the CMHCs of 
counties across California in the United States. As explained above, the present protocol describes Phase 
2, the Train-the-Trainer Phase, of a three-part hybrid type 2 effectiveness-implementation study. The 
Train-the-Trainer Phase builds upon the infrastructure of the Implementation Phase (42). Specifically, 
during the Implementation Phase, sites are cluster-randomized by county to Adapted TranS-C or Standard 
TranS-C with 1:1 allocation. External expert trainers train an initial cohort of providers (i.e., Generation 1 
providers) in TranS-C via facilitation. Then, within each county, patients are randomized to receive 

13 
 
immediate TranS-C or UC-DT from Generation 1 providers. 
 
In the Train-the-Trainer Phase, expert trainers offer additional training for Generation 1 providers to 
become “local trainers” in TranS-C. Then, these local trainers train the next cohort of providers (i.e., 
Generation 2 providers) within their organization in TranS-C (see Figure 1). Then, within each county, 
patients are randomized to receive immediate TranS-C or UC-DT from Generation 2 providers. Patients 
treated by Generation 2 providers are referred to as “Generation 2 patients.” Sites retain their original 
randomization assignment to Adapted or Standard TranS-C. See below for more details on the TTT 
procedures. 
 
Aims and hypotheses for the Train-the-Trainer Phase mirror the Implementation Phase (42). Parallel 
analyses to the Implementation Phase will allow us to test the extent to which implementation and 
effectiveness outcomes are maintained with TTT.  
 
The first aim is to assess the effectiveness of TranS-C, compared to UC-DT, in patients who are treated 
by Generation 2 providers. We hypothesize that, compared to UC-DT, TranS-C (combined Adapted and 
Standard) will be associated with larger reductions in the primary patient outcome of sleep disturbance 
and the secondary patient outcomes of sleep-related impairment, functional impairment, and psychiatric 
symptoms. We also hypothesize that TranS-C’s benefits for functional impairment and psychiatric 
symptoms will be mediated by improvements in sleep and circadian problems. The second aim is to 
evaluate whether TranS-C treatment condition (Adapted vs. Standard TranS-C) is associated with fit to 
the CMHC context, operationalized as provider ratings of acceptability, appropriateness, and feasibility, 
for Generation 2 providers. We hypothesize that Adapted TranS-C will be superior to Standard TranS-C 
with respect to the primary provider outcome of acceptability and the secondary provider outcomes of 
appropriateness and feasibility. The third aim is to evaluate whether perceived fit among Generation 2 
providers mediates the relation between TranS-C treatment condition and Generation 2 patient outcomes. 
We hypothesize that relative to Standard TranS-C, Adapted TranS-C will be associated with greater 
reductions in the primary and secondary patient outcomes indirectly through higher provider ratings of 
acceptability, appropriateness, and feasibility. Exploratory analyses will: (1) compare whether the 
effectiveness of TranS-C for primary and secondary patient outcomes is moderated by generation, (2) 
compare Adapted and Standard TranS-C on Generation 2 patient perceptions of credibility and perceived 
improvement and select PhenX Toolkit outcomes that are both strongly related to SMI and sleep and 
circadian problems (e.g., substance use, suicidality) (43–46) and of high priority to our community 
partners; and (3) determine whether treatment effects for Generation 2 patients are moderated by risk 
factors including age, sex, and sleep and circadian and psychiatric symptoms at baseline. In particular, 
emerging evidence suggests that patients who are older and have more severe sleep and circadian and 
psychiatric symptoms at baseline demonstrate poorer response to sleep and circadian treatment, whereas 
outcomes by sex have been mixed for patients with SMI (47,48). 
3 METHODS 
 
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 (49) (see SPIRIT checklist in supplemental documents and Table 2). 
 

14 
 
3.1 Train-the-Trainer 
 
Throughout Phases 1 (Implementation Phase) and 2 (Train-the-Trainer Phase), implementation is 
conducted via facilitation (50). 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 (51–53). 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 (50) 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. 
 
3.1.1 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 (42). 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. 
 

15 
 
3.1.2 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. 
 
3.2 Participants 
 
Participants in the present study are drawn from CMHCs and consist of local trainers, Generation 2 
providers, and Generation 2 patients1. 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 (42). 
 
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-
 
1 Note that the vast majority of providers and patients were employed by or seeking/receiving treatment at CMHCs. 
However, in very few isolated instances, providers and patients outside of CMHCs learned about the study (e.g., by 
word of mouth) and requested to participate. When the providers or patients otherwise met the criteria, they were 
permitted to participate, and were matched with a CMHC patient or provider, respectively, by the facilitation team. 

16 
 
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 (54,55); 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 
(56) 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. 
  
3.3 Recruitment 
3.3.1 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. 
 
3.3.2 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. 
 
3.3.3 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 

17 
 
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. 
 
3.3.4 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. 
 
3.4 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. 
 

18 
 
3.4.1 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. 
 
3.4.2 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 (57,58). 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 (36,47). 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) (59). Next, we considered TranS-C’s theoretical underpinnings and mechanisms of action 
(27,60) from which we retained the core elements (58,61). 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 (36,47). 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) (58,62,63). The present trial will address the last two phases of REP – namely, 
Phases 3 (Implementation) and 4 (Maintenance and Evolution). 
 
3.4.3 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 Figure 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 (64–66). 

19 
 
 
3.5 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. 
 
3.5.1 Generation 2 Providers 
 
3.5.1.1 Primary Outcomes 
 
Acceptability. Generation 2 providers rate the acceptability of TranS-C via the Acceptability of 
Intervention Measure (67). 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 (67). 
 
3.5.1.2 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 (67). 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 (67). 
 
3.5.1.3 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. 
 
3.5.2 Generation 2 Patients 
 
3.5.2.1 Primary Outcomes 
 
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 (54). 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 
(54,55). 
 
3.5.2.2 Secondary Outcomes 
 
Sleep-Related Impairment. The 16-item PROMIS-Sleep Related Impairment (PROMIS-SRI) assesses 

20 
 
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) (54). Scores range from 16-80, with higher scores indicating greater impairment 
(e.g., daytime sleepiness, difficulty concentrating). This measure has demonstrated excellent 
psychometric properties (54,55).  
 
Functional Impairment. Functional impairment is assessed via the Sheehan Disability Scale (SDS) (68). 
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 (68,69). 
 
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 (70). 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 (70).  
 
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 (71,72). 
 
3.5.2.3 Exploratory Outcomes 
 
PhenX Toolkit: Substance Use and Suicidality. Scales from the PhenX Toolkit (73) 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 (73). 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) (74). These questions assess (1) how logical TranS-C seemed, (2) how successful it was in 

21 
 
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%. 
 
3.6 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. 
 
3.6.1 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) (42). 
 
3.6.2 Generation 2 Providers 
 
Provider assessments are completed after they complete TranS-C training, as well as at post-treatment. 
See Figure 3 for provider timeline. 
 
3.6.3 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 

22 
 
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 Figure 2 for patient timeline. 
 
3.7 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 (47,75,76). 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). 
 
3.8 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 (42). 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 (77) 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 (78). 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) (67). Based on the ICC estimated from similar prior 
provider-level studies (38,79), 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 (78). 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) (80). 
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 

23 
 
(2017) application was conducted with 1,000 replications, 20,000 Monte Carlo draws per replication, and 
95% confidence intervals (81). Drawing from prior research, medium correlations (r = 0.30) were 
assumed between the predictor (TranS-C condition) and mediators (acceptability, appropriateness, 
feasibility; (80) as well as mediators and outcomes (r = 0.50). Small correlations (r = .20) were assumed 
between the predictor and outcomes (82). 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. 
 
3.9 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. 
 
Organizations not directly involved in the trial (e.g., NIMH, Data Safety Monitoring Board, Institutional 
Review Board) have the right to audit and, if such a situation arises, will determine the frequency and 
procedures for auditing. The project management team regularly audits the monthly enrollment as well as 
the completeness and quality of the data. 
 
Outcomes specifically of interest to our partners are presented to CMHC leadership as part of the widely-
used implementation strategy, audit and feedback (83). 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. 
 
3.10 Roles and Responsibilities 
 
This trial is supervised by the PI (AGH), who manages the facilitation team, assessment team, and the 

24 
 
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. 
 
3.11 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. 
4 PLANNED ANALYSES 
4.1 Preliminary Analyses and Missing Data 
 
All analyses below pertain to the TTT Phase and are limited to Generation 2 providers and Generation 2 
patients, except Exploratory Aim 1. For the primary analyses, which use multilevel modeling (MLM) and 
structural equation modeling, analyses will use all available data (intent-to-treat) (84). Models will be 
estimated with maximum likelihood estimation, and missing data will be assumed to be missing at 
random (85). For exploratory analyses using linear regression, approaches to missing data will be based 
on the number of missing cases (e.g., listwise deletion versus multiple imputation) (86). If dropout is 
related to other variables, they will be included as predictors. Baseline between-group differences in 
demographic variables will be examined. These tests will not be used to select covariates in the primary 
intention-to-treat analysis (87–90). Instead, covariates will be carefully selected at the conclusion of the 
trial—given the variations due to COVID-19 and the CMHC context (see Discussion)—and the potential 
influences of baseline differences will be evaluated as moderators (approach to moderation described 
below). Analyses comparing TranS-C to UC-DT will evaluate change in outcomes from pre-treatment to 
post-treatment. Analyses comparing Adapted to Standard TranS-C will evaluate change in Generation 2 
outcomes from pre-treatment to post-treatment and pre-treatment to 6FU (see Method and Discussion for 
more details). 
 
Distributions will be evaluated to detect outliers, and we will ensure that the assumptions of planned 
analyses are met. Covariates will include the patient variables for which we stratified (i.e., age and 
presence of psychosis or substance use). For all statistical models, counties will be adjusted for as a factor 

25 
 
variable rather than a level of analysis due to the relatively small number of clusters. The average 
intraclass correlation on provider and patient level outcomes will be reported. 
 
4.2 Dropout 
 
The N by stage of dropout will be reported for the following: dropout after randomization but before the 
first treatment session, dropout after treatment has begun but attended half or fewer of the intended 
number of sessions (i.e., ≤ 2 in Adapted, ≤ 4 in Standard), dropout after attended more than half the 
intended number of sessions (i.e., > 2 in Adapted, > 4 in Standard) but before treatment has been 
completed, and dropout after treatment has been completed but prior to post-treatment or 6FU 
assessments. The number of Generation 2 patients who completed a post-treatment assessment but were 
lost to 6FU will also be reported. When available, the reasons for dropout and improvement among 
patients who drop out will be reported.  
 
4.3 Aim 1: Effectiveness Outcomes of Standard or Adapted TranS-C versus UC-DT 
 
Multilevel modeling (MLM) (91–93) will be used to account for multiple observations nested within 
patient. The level 1 equation will include dummy-coded time indicators as the predictor (0 = pre-
treatment, 1 = post-treatment). The level 2 equation will include dummy-coded treatment condition (0 = 
UC-DT, 1 = Adapted or Standard TranS-C) and treatment by time interaction terms as predictors, 
adjusting for county. The treatment effects of interest will be significant treatment by time interactions at 
the 5% level on the primary outcome of sleep disturbance and the secondary outcomes of sleep-related 
impairment, functional impairment, and psychiatric symptoms, all modeled as continuous variables. 
Significant treatment by time interactions indicate that change in Generation 2 patient outcomes is 
significantly different comparing Adapted or Standard TranS-C to UC-DT. Significant interactions will 
be interpreted using planned contrasts (i.e., treatment effects on change from pre-treatment to post-
treatment) and graphs. Additionally, the indirect effects of TranS-C relative to UC-DT on functional 
impairment and psychiatric symptoms through improvements in sleep disturbance and sleep-related 
impairment will be tested using multilevel structural equation modeling (94). 
 
4.4 Aim 2: Adapted TranS-C versus Standard TranS-C on Fit to CMHC Context 
 
MLM will be used to account for multiple observations nested within Generation 2 providers. TranS-C 
treatment condition (Adapted versus Standard TranS-C) will be evaluated as a predictor of fit, 
operationalized as Generation 2 provider ratings of acceptability, feasibility, and appropriateness. The 
level 1 equation will include dummy-coded time indicators as the predictor (0 = post-training, 1 = post-
treatment). The level 2 equation will include dummy-coded treatment condition (0 = Standard TranS-C, 1 
= Adapted TranS-C) and treatment by time interaction terms as predictors, adjusting for county. The 
treatment effects of interest will be significant treatment by time interactions at the 5% level on the 
primary outcome of acceptability and the secondary outcomes of feasibility and appropriateness, all 
modeled as continuous variables. Significant treatment by time interactions indicate that change in 
perceptions of fit is significantly different comparing Adapted to Standard TranS-C. Significant 
interactions will be interpreted using planned contrasts (i.e., treatment effects on change from pre-
treatment to post-treatment) and graphs. 
 

26 
 
4.5 Aim 3: Fit as a Mediator of Treatment Condition and Patient Outcome 
 
Multilevel structural equation modeling (94) will be used to test whether improved perceptions of fit (i.e., 
acceptability, appropriateness, and feasibility) mediate the relation between TranS-C treatment condition 
(i.e., Adapted versus Standard TranS-C) and change in the primary patient outcome of sleep disturbance 
and the secondary patient outcomes of sleep-related impairment, functional impairment, and psychiatric 
symptoms in Generation 2. Models will evaluate change in outcomes from pre-treatment to post-treatment 
and pre-treatment to 6FU. 
 
4.6 Sensitivity Analyses 
 
Three sets of sensitivity analyses will be run to help account for the complexities of the COVID-19 
pandemic and the CMHC context. In the first set, the analyses for Aims 1-3 will be conducted with (a) 
treatment completers, (b) patients who completed more than half the number of the suggested sessions 
(i.e., > 2 sessions for Adapted and > 4 sessions for Standard), and (c) patients who completed half or 
fewer of suggested sessions. In other words, these analyses will test the effectiveness of TranS-C at 
varying doses, which may be important considering evidence on “early responders” (95) and “real world” 
contexts where turnover and dropout can be high (96,97). In the second set of sensitivity analyses, we will 
assess whether any patients who did not complete post-treatment or 6FU had achieved meaningful clinical 
improvement by mid-treatment, using a reliable change index for the primary outcome of PROMIS-SD 
(98). For the sensitivity analyses, we will define these patients (i.e., did not complete post-treatment or 
6FU but achieved clinically meaningful improvement) as completers, and we will use their mid-treatment 
assessment in place of a post-treatment assessment. Then, all pre- to post-treatment analyses for Aims 1-3 
will be rerun. In the third set of sensitivity analyses, we will run the analyses for Aims 1-3 but only 
include post-treatment and 6FU assessments that were collected within 3 months of the target assessment 
date (e.g., a 6FU assessment that was completed nine months after treatment ended). 
 
4.7 Exploratory Aim 1: Generation 1 Compared to Generation 2 on Patient Outcomes 
 
To compare Generation 1 and Generation 2 on primary and secondary patient outcomes of TranS-C, data 
from the Implementation Phase (see Sarfan et al., 2023) and the TTT Phase and both TranS-C conditions 
(Adapted and Standard) will be combined. MLM will be used to evaluate interactions between generation 
(Generation 1 or Generation 2) and time. The level 1 equation will include dummy-coded time indicators 
as the predictors (0 = pre-treatment, 1 = post-treatment). The level 2 equation will include dummy-coded 
generation (0 = Generation 1, 1 = Generation 2) and treatment by time interaction terms as predictors, 
adjusting for county. A significant interaction indicates a moderating effect of generation and will be 
probed with planned contrasts (e.g., effects of generation on change from pre-treatment to post-treatment) 
and graphs. 
 
4.8 Exploratory Aim 2: TranS-C Treatment Condition on PhenX Toolkit and Perceived Credibility 
and Improvement 
 
MLM will be used to test TranS-C treatment condition (Adapted vs. Standard TranS-C) predicting change 
in PhenX Toolkit outcomes of substance use and suicidality from pre-treatment to post-treatment and pre-
treatment to 6FU in Generation 2. The approach to MLM will mirror Aim 2, except the focus will be the 
Generation 2 patient data, outcomes will be substance use and suicidality from the PhenX Toolkit, and 
models will evaluate change from pre-treatment to 6FU. Linear regression will be used to test treatment 

27 
 
condition (Adapted vs. Standard TranS-C) predicting patient perceptions of TranS-C’s credibility and 
perceived improvement at post-treatment. 
 
4.9 Exploratory Aim 3: Treatment Effects Moderated by Risk Factors 
 
Using MLM, three-way interactions between treatment condition (Adapted or Standard TranS-C versus 
UC-DT), time, and risk factors will be used to evaluate moderators of Generation 2 patient outcomes (i.e., 
sleep and circadian problems, functional impairment, and psychiatric symptoms). Each moderator and 
outcome will be tested in a separate model. Moderators will include age, sex, and sleep/circadian and 
psychiatric symptoms at baseline. The level 1 equation will include the moderator and dummy-coded time 
indicators as the predictors (0 = pre-treatment, 1 = post-treatment). The level 2 equation will include 
dummy-coded treatment condition (0 = UC-DT, 1 = Adapted or Standard TranS-C) and treatment by time 
by moderator interaction terms as predictors, adjusting for county. A significant interaction indicates a 
moderating effect and will be probed with planned contrasts (e.g., moderating effects on the differences 
between treatments in change from pre-treatment to post-treatment) and graphs. Simple slope analyses 
will be conducted for significant continuous moderators. 
5 DISCUSSION 
 
The second of a three-phase hybrid type 2 trial, the Train-the-Trainer Phase, aims to evaluate the 
implementation and effectiveness outcomes of the Transdiagnostic Intervention for Sleep and Circadian 
Dysfunction (TranS-C) delivered to patients in community mental health centers (CMHCs) by providers 
who are trained and supervised within CMHCs via train-the-trainer (TTT). 
 
This novel study has the potential to make several significant contributions to the literature. First, to the 
best of our knowledge, this is the first study to utilize a TTT approach to implement sleep treatment for 
adults with serious mental illness (SMI) in CMHCs. Importantly, treating sleep and circadian dysfunction 
may be an efficient way to reduce the substantial societal burden of serious mental illness (35,99) and few 
providers have received training in evidence-based sleep treatment (100,101). Second, this study will 
assess the effectiveness of TranS-C in patients who are treated by Generation 2 providers (i.e., providers 
who were trained and supervised within CMHCs via TTT). As such, we will add to the growing body of 
work evaluating whether outcomes hold as training and supervision responsibilities transfer across 
generations of TTT. Third, this study evaluates two versions of TranS-C – Standard TranS-C and Adapted 
TranS-C – to determine if “fit” could be improved for Generation 2 providers. This is crucial as fit is an 
important predictor of implementation outcomes (39,40,102), yet the impact of fit across generations of 
TTT is relatively unexplored. Evaluating this unique combination of implementation strategies – namely, 
TTT and treatment adaptation to improve fit to context – will contribute to the burgeoning evidence on 
causality in implementation science (103). 
 
The potential contributions of this protocol must be considered alongside its methodological limitations. 
First, given real-world factors, particularly the COVID-19 pandemic, our sample size is unlikely to be 
optimal and analyses may be underpowered. That said, estimates of the minimum detectable effect size 
presented above suggest that the anticipated sample sizes for providers and patients may be sufficient for 
Aim 1 and we will use effect sizes in conjunction with p-values to interpret the findings for Aims 2 and 3. 
Additionally, relative to the existing TTT literature in CMHCs, the current estimated sample for both 
providers and patients is substantial (8). Nonetheless, it is crucial for future research to examine TTT with 
larger samples to allow for more sophisticated analyses on the multitude of factors that may influence 
TTT outcomes. 
 

28 
 
Second, to reduce burden on our CMHC collaborators, we did not collect data from leadership nor local 
trainers at our partner CMHCs about their perceptions or feedback on TTT. We recognize that leadership-
level factors can meaningfully impact implementation outcomes (104). Therefore, exploring leadership 
perspectives on TTT and TranS-C is an important direction for future research. Additionally, very few 
studies have collected data from local trainers (21). Thus, this area is ripe for both qualitative and 
quantitative research on a range of factors, such as local trainer attributes, effectiveness, competence, and 
perceptions of barriers and facilitators to sustaining the EBPT. 
 
Third, as is common in TTT studies, our follow-up period is relatively brief (i.e., 6FU of TranS-C). It 
would be informative for future research to monitor outcomes over several generations of trainers and 
supervisors to provide robust tests of long-term TTT sustainability. Additionally, in the UC-DT condition, 
patients did not complete a 6FU assessment after the delay, and we did not collect 6FU data from 
providers. These were compromises made with CMHC partners to reduce burden and maximize 
participation in the study. Increasing our follow-up period to study the long-term effects of TranS-C 
relative to a control (e.g., UC-DT) and Generation 2 providers’ perceptions of TranS-C will be important 
directions for future research.    
 
Fourth, flexible design choices were made at the facilitator, local trainer, and provider levels to respect 
the expertise and preferences of our CMHC partners. At the facilitator level, facilitation was scaffolded to 
meet the individualized needs of CMHC staff (including leadership, local trainers, and providers) in the 
transition to TTT. While standardized training procedures for local trainers were followed, evaluating the 
“readiness” of local trainers to lead trainings and supervisions was done on a case-by-case basis by the 
expert trainer, given the dearth of validated measures to guide this decision-making process. The 
development of optimal strategies for evaluating readiness and supporting trainers and supervisors in 
developing necessary skills for TTT should be a focus of future research (16). At the local trainer level, 
individual trainers selected their preferred format for supervision of Generation 2 providers (e.g., group 
vs. individual, regular vs. as needed). At the provider level, providers had the option to deliver TranS-C in 
a group or individual format (42). Collectively, these choices reflect the real-world restrictions and 
preferences of CMHC partners but introduced variance into the study. However, it has been critical to the 
CMHCs, local trainers, providers, and patients that we balance rigor with flexibility. At the conclusion of 
the trial, the sources of variation that resulted from the needs/preferences of our community partners will 
be carefully considered as to whether they should be included as covariates. Future research with larger 
sample sizes could consider standardizing and/or randomizing these variables to examine variations in 
TTT and identify any “tipping points” beyond which fidelity and clinical outcomes are undermined (16).   
 
Finally, another potential limitation is sampling effects. The CMHCs, providers, local trainers, and 
patients who agreed to participate may not be representative of community mental health in general (e.g., 
with respect to perceptions of EBPTs, prior training in EBPTs). Nevertheless, a core strength of this study 
is that it is located entirely within practicing community mental health centers, and TranS-C is delivered 
as part of routine practice. In other words, this study takes steps toward ecological validity and support for 
effectiveness.   
 
In sum, this study has the potential to (a) train a large number of CMHC providers and embed 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 Generation 2 outcomes 
with a novel treatment and population, and (c) advance our understanding of providers’ perceptions of 
EBPT ‘fit’ across generations of TTT. Together, this study takes important steps toward testing 
implementation strategies (i.e., TTT and treatment adaptation) that have the potential to meaningfully 
impact the scale-up and sustainability of EBPTs. 
 

29 
 
6 TRIAL STATUS 
 
Protocol version 1, May 11th, 2023. Data collection for the Train-the-Trainer Phase started in December 
2020.  Recruitment for the Train-the-Trainer Phase started in December 2020. Patient and provider 
assessments will continue through August 2023. Publishing of this protocol was delayed because of 
unforeseen challenges and uncertainties related to the COVID-19 pandemic and subsequent mandates 
(e.g., shelter-in-place), which began in California shortly after data collection started for this study. Also, 
during the Implementation Phase 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. 
7 DECLARATIONS 
7.1 Ethics approval and consent to participate 
 
The Committee for the Protection of Human Subjects at the University of California, Berkeley approved 
this study (2019-04-12091). Written informed consent is obtained from all participants. 
 
7.2 Consent for publication 
 
Model consent forms are available upon request. 
 
7.3 Availability of data and materials 
 
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 their requirements. 
 
7.4 Competing interests 
 
AGH, LDS, AMK, DJB, CAC, MD, and LD have received National Institutes of Health funding. AGH 
has received book royalties from Guilford Press and Oxford University Press.   
 
7.5 Funding Agency and Sponsor 
 
This study is funded by the National Institute of Mental Health (R01MH120147) and the sponsor is the 
University of California, Berkeley (University Avenue and Oxford Street, Berkeley, California, 94720; 
510-642-6000). Neither the sponsor nor the funding agency has/had no role in the design, collection, 
management, analysis, or interpretation of data; the writing of the manuscript; or the decision to submit 
the study protocol for publication. Neither the sponsor nor the funding agency has ultimate authority over 
any of these activities. Additionally, the views expressed are those of the authors and do not necessarily 
represent the views of the Department of Veterans Affairs or any public entity. 
 

30 
 
7.6 Authors' contributions 
 
AGH, LD, DJB, and AMK conceived of and designed the study and acquired the funding. AGH, ERA, 
MD, KF, JMS, SAH, REH, and CAC are responsible for acquisition of data. CAC, LDS, and AGH 
drafted the manuscript. All authors were involved in revising the manuscript. All authors read and 
approved the final manuscript. 
 
7.7 Acknowledgements 
 
We are deeply grateful to all the community partners, including the CMHC leadership, staff, and patients, 
whose partnering was essential to this study. 
 
 

31 
 
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