SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care
Phase: NA
Conditions: Depression, Anxiety
Sponsor: University of California, Irvine

 
 
 
 
 
 
Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy 
for 
Spanish-speaking Patients (SUPERA) 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
NCT Number: Pending 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
September 18, 2022 

Study Application (Version 1.3)
1.0
General Information
*Enter the full title of your study:
SUpport from PEeRs to expand Access study
 
 
*Enter the study alias:
SUPERA 
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - M_Psych-ZSFG-Admin
133110
UCSF - 
 - M_MED-ZSFG-DGIM
138336
UCSF - 
 - M_Psych-LPPI-Rsch
133144
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Aguilera, Adrian, PhD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Fortuna, Lisa R MD, MPH 
 Other Investigator
Lyles, Courtney R PhD, PhD 
 Other Investigator
Ochoa-Frongia, Lisa M MD 
 Other Investigator
Schueller, Stephen M 
N

 Co-Principal Investigator
B) Research Support Staff
Rosales, Karina 
 Research Assistant
3.3 *Please add a Study Contact
 
Aguilera, Adrian, PhD 
Rosales, Karina 
Schueller, Stephen M 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions 
Updated Sept 2022 - Revised Common Rule (January 2018) Compliant / COVID-19 - 
v98
4.1  * 
:
PROJECT SUMMARY  (REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
Latinxs with Limited English Proficiency (LEP) experience longer duration of untreated mental 
health disorders (Gonzalez, Alegría, Prihoda, Copeland, & Zeber, 2011; Falgas, Ramos, & Herrera, 
et al., 2017). For depression and anxiety, Latinxs are half as likely as whites to receive quality, 
evidence-based care despite primary care providers recommending treatment at equivalent rates 
(Kim, Aguado, Chiriboga, Jang, Parmelee, & Allen, 2011; Sentell, Shumway, & Snowden, 2007). 
LEP Latinx patients are disproportionately on Medicaid or uninsured and therefore are more likely 
to receive care in public healthcare settings. Although efforts are made to integrate behavioral 
health into primary care in a culturally sensitive manner, there is nonetheless a severe deficiency 
of Spanish-speaking behavioral/mental health clinicians (Bauer, Chen, & Alegría, 2011). In 
addition, public healthcare systems are often under-resourced and less likely to be the site for 
implementation of innovations that might increase access to mental health care for their 
population. Multiple innovations, such as the use of technology and peer support (Kazdin, & 
Blase, 2011), in mental healthcare could help alleviate these problems.
Over the past decade, an increasing number of behavioral and psychological interventions have 
used the Internet and mobile technologies to provide efficacious treatments (Richards, & 
Richardson, 2012). The efficacy of such interventions has led to the recommendation that they 
should be frontline treatments for mental health issues including depression and anxiety ((NICE) 
NIfHaCE, 2006, (NICE) NIfHaCE, 2009). Despite this recommendation, few patients have access 
to evidence-based digital treatments, and even when available, uptake and engagement – both 
by providers and patients (Gilbody, Littlewood, Hewitt, et al., 2015) – is often low. As such, we 
need to develop and evaluate implementation strategies to support integration of digital mental 

health into healthcare settings
, especially those settings where access to evidence-based 
11
mental health care is lacking. 
Digital interventions are especially relevant for low-resource settings as they are scalable and can 
deliver evidence-based practices with fidelity while minimizing the need for specialty mental 
health providers – which is critical for understaffed public delivery systems. Previous evidence has 
shown that human support, both by professionals as well as peers, can increase the uptake and 
effectiveness of digital mental health interventions. Therefore, in order to sustainably spread 
digital health treatment options for LEP Latinx patients treated in safety-net healthcare settings, 
we must test implementation strategies that include a) warm hand offs of digital mental health 
treatments from staff and/or providers (inreach) and registry-based outreach as well as b) the 
use of peers to supplement the treatment with linguistically-congruent and culturally-sensitive 
support and extension. Most importantly, leveraging peers for delivering digital interventions may 
produce solutions that are more feasible, scalable, and ultimately cost-effective than 
professionally-supported interventions. 
In the proposed SUPERA (SUpport from PEeRs to expand Access) study, we will evaluate the 
implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy 
(dCBT) intervention (SilverCloud) in safety-net primary care clinics for LEP Latinx patients with 
depression and/or anxiety. We will conduct an effectiveness-implementation hybrid trial (Type 2) 
(Curran, Bauer, Mittman, Pyne, & Stetler, 2012) design with both provider- and patient-level 
randomization. At the provider-level we will compare outreach (using our clinic patient registry) 
with inreach (traditional provider referral), at the patient-level we will compare two modes of 
delivery of the dCBT platform – peer-supported and unsupported. The SUPERA study will involve 
implementation into the San Francisco Health Network at the Zuckerberg San Francisco General 
Hospital serving 21,076 patients.  Our previous work has included providing digital and mental 
health treatments to this same population.
4.2  
 
* 
:
HUD DEVICE (REQUIRED) 
 
Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  * 
: 
TYPE OF RESEARCH (REQUIRED) 
(
Select the option that best fits your project Click the orange 
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use, 
other healthcare or health outcomes related activities, research database, biospecimen bank, 
or recruitment registry) 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 
biological measures) 
4.4  * 
 
SUBJECT CONTACT: (REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
 
* RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening 
:
procedures and study activities
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):

Full Committee 
Expedited 
Exempt 
Generally, only 
studies require 
Greater than Minimal Risk 
Full 
. 
Committee Review We suggest you check 
 
Expedited Review
instead or change the risk level, if you checked the wrong box.
4.9  
 
* DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study 
 involve records review and
ONLY
/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment database, or 
biospecimen repository):
  Yes  
  No
4.10  
 
* CLINICAL TRIAL: (REQUIRED)
Is this a clinical trial:
According to The World Health Organization (WHO) and the 
International Committee of Medical Journal Editors (ICMJE) a 
 
clinical trial is:
Any research study that prospectively assigns human participants or 
groups of humans to one or more health-related interventions to 
evaluate the effects on health outcomes.
ICMJE requires 
 of a clinical trial in a public database (such as 
registration
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in 
member biomedical journals.
Public Law 110-85 requires that all investigators who perform 
Guidance: 
an 
 must ensure that the trial is registered on a 
applicable clinical trial
 
.
government web site called ClinicalTrials.gov
 
The FDA requires registration for 'applicable clinical trials,' defined 
as follows:
For any trials of drugs and biologics: controlled clinical investigations, 
other than Phase 1 investigations, of a product subject to FDA 
regulation.
For trials of biomedical devices: controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and pediatric post-market surveillance.
 
 
For additional information on the ClinicalTrials.gov registration process at 
UCSF and the definition of a clinical trial for purposes of registration, visit 
 
the ClinicalTrials.gov section of the UCSF Clinical Research Resource 
.
HUB
 
 
 Yes  
 No
 - 'NCT' number for this trial:
Clinical Trial Registration
Pending

4.11  * 
: 
CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s):
Phase 0
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  
: 
* INVESTIGATOR-INITIATED (REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
 of the 
 to 
The UCSF IRB recommends use
Virtual Regulatory Binder
manage your study.
4.13  * 
 
CORONAVIRUS RESEARCH: (REQUIRED) Does this study involve research on coronaviruses (COVID-
19, SARS, MERS or other):
  Yes  
  No
4.15  
 
*
 
CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer 
or at risk for cancer, including behavioral research, epidemiological research, public policy research, 
specimen analysis, and chart reviews):
  Yes  
  No
4.16  * 
 
RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to patients
/subjects 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-
EITHER
standard care OR 
research
guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes  
  No
4.17  
 
* HIV SCREENING: (REQUIRED)Does this study involve screening for HIV infection:
You should answer 'Yes' if the protocol includes HIV testing even if it's just 
for screening to determine eligibility.
  Yes  
  No
4.18  *
 
 SCIENTIFIC REVIEW: (REQUIRED) If this study has undergone scientific or scholarly review, 
please indicate which entity performed the review (check all that apply):
Funding agency, cooperative group, study section or other peer-review process
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
Departmental scientific review
CTSI Consultation Services
Other:
Has not undergone scientific/peer review

 
* Specify entity that provided review:  (REQUIRED)
National Institute of Mental Health
4.19  
 
* STEM CELLS: (REQUIRED)
 
Does this study involve
 
human stem cells (including iPS cells and adult 
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.20  
 
 
*
 
FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse, 
 
 
registered domestic partner and/or dependent children thereof) have financial interests related to 
 
this study:
  Yes  
  No
5.0
 Funding
5.1  
 
* FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
 Yes  
 No
* UCSF requires the PI to certify that the research activities described in 
their IRB application are consistent with those described in the fiscal and 
materials sources of support listed in the grant application(s). Check the 
relevant box below: (REQUIRED)
The research activities described in this application are wholly consistent with those described 
in the grant application(s) 
The research activities described in this application differ from those described in the grant 
application (or, if there are multiple federal grants, the research activities described in this 
application differ from those described in one or more of the grant applications). Explain the 
discrepancies in the designated box within the funding details area below. 
This study is partially or fully supported with federal funds but there's no grant. 
5.2  
 
* 
Is this project linked in any way to the Department of Defense (DoD):
DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 

NIH Natl Institute 
of Mental Health 
01 
Other (No 
funding 
comes 
through 
UCSF C&G 
unit) 
 
 
 
Sponsor Name:
NIH Natl Institute of Mental Health 
Sponsor Type:
01 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
1R01MH126664 
Awardee Institution::
Other (No funding comes through UCSF C&G unit) 
Is Institution the Primary 
Grant Holder:
No 
if No, then who is the Primary 
Grantee?
University of California, Irvine 
Contract Type:
 
Project Number:
 
UCSF RAS System Award 
Number ("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
 
PI Name:
(If PI is not the same as 
identified on the study.)
Stephen Schueller, PhD  
Explain Any Significant 
Discrepancy:
 
Other Funding Sources and Unfunded Research - Gift, Program, 
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply): 
 UCSF AND AFFILIATED SITES
*
(REQUIRED)
UCSF Benioff Children's Hospital Oakland (BCH OAK)
UCSF Cancer Center Berkeley
UCSF Cancer Center San Mateo
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore 
Women's Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals 

and clinics)
UCSF Fresno
Gladstone Institutes
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
San Francisco VA Health Care System (SFVAHCS) – including Community-Based Outpatient 
Clinics (CBOCs)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
Zuckerberg San Francisco General (ZSFG)
Research involving SFDPH/ZSFG: A UCSF Research at SFDPH 
Protocol Application is required for all research. Review 
 
this link for 
more information and contact information for SFDPH/ZSFG 
questions. SFDPH sites and clinics have special requirements that 
you must be familiar with. The UCSF IRB will only review SFDPH 
IRB Applications with 
.
designated SFDPH PIs
6.2  
At what locations will study visits and activities occur: 
 LOCATIONS: 
*
(REQUIRED)
                                                                        
The Richard Fine People’s Clinic (RFPC) and the Family Health Center (FHC) at ZSFGH will serve 
as the study sites.
                       
Enrollment procedures will take place at ZSFG. 
    
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
 Yes  
 No
Please identify which procedures may be done off-site:
Peers supporters which are affiliated with community organizations will conduct weekly check-ins 
with study participants and study staff. Supporters will be supervised by study staff. 
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
Weill Institute for Neurosciences Translational Research Unit (WIN TRU)
6.5  * CTSI CRS SERVICES: (REQUIRED)Will this study be carried out at one of the UCSF Clinical Research 
 Units or utilize CRS Service:
Services (CRS)
  Yes  
  No
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:

By 
' we mean a study where the protocol is developed 
'multi-center trial
by an lead investigator, an industry sponsor, consortium, a disease-group, 
etc.,and multiple sites across the nation or in different countries participate 
in the trial. The local sites do not have any control over the design of the 
protocol.
  Yes  
  No
6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are 
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical trial, 
UCSF is just one of the sites, and neither UCSF nor one of its faculty-
linked affiliates (SF VAHCS, Gladstone, ZSFG) are the coordinating 
center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.9  
Check any other UC campuses with which you are collaborating on this 
OTHER UC COLLABORATORS: 
research study:
UC Berkeley
UC Davis
Lawrence Berkeley National Laboratory (LBNL)
UC Irvine
UC Los Angeles
UC Merced
UC Riverside
UC San Diego
UC Santa Barbara
UC Santa Cruz
6.10  
Are any of the above UC campuses requesting to rely on UCSF's IRB (check all that 
 
UC RELIANCES:
apply)?
Yes
No
6.15  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an 
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus, 
commercial, or institutional):
  Yes  
  No
6.16  
 
* RELIANCE AGREEMENT TYPE: (REQUIRED) Under what Reliance Agreement is UCSF being 
requested to rely:

UC MOU
SMART IRB
Established Consortium Agreement, if applicable
Private IRB Master Service Agreement
Other (specify below)
Unknown
6.18  
What is the 
 Number: 
* UC RELIANCE REGISTRY NUMBER: 
UC IRB Reliance Registry
(REQUIRED)
Study #3995: SUpport from PEeRs to expand Access (SUPERA)
7.0
 Research Plan and Procedures
7.1  
Describe the hypothesis or what the study hopes to prove: 
 HYPOTHESIS: 
*
(REQUIRED)
Hypothesis 1: We predict peer-supported dCBT will result in greater improvement in mental 
health symptoms (co-primary outcomes, as measured by PHQ-9 and GAD-7) and functioning 
(secondary outcomes, as measured by PROMIS social health) and higher patient engagement 
(secondary outcome and mediator, as measured by time on platform) compared to unsupported 
dCBT.
Hypothesis 2: We predict an outreach (registry based direct-to-consumer) strategy will result in 
more patients referred, more patients initiating, and lower relative cost compared to inreach 
(provider referral). 
7.2  
List the specific aims: 
 AIMS: 
*
(REQUIRED)
Aim 1: Evaluate patient-level randomization in the SUPERA study on effectiveness of dCBT 
modalities. Patients who initiate dCBT will be randomized to a two-armed trial comparing peer-
supported vs. unsupported dCBT (SilverCloud). 
Aim 2: Evaluate provider-level randomization in the SUPERA study on implementation strategies. 
We will use block randomization to assign blocks of providers to a two-armed trial comparing 
outreach vs. inreach. Implementation evaluation will follow the RE-AIM model. The primary 
outcome will be reach as defined by the proportion of eligible patients referred and initiating dCBT 
comparing outreach vs inreach strategies. 
Aim 3: Evaluate putative mechanisms of change for the intervention and implementation 
strategies. We will conduct a mixed-methods evaluation consisting of surveys, interviews, and 
focus groups. Aim 3a): We will include patients and peers to assess attitudes towards the 
intervention, support component, cultural relevance as well as relationship factors and CBT skills 
use, knowledge, and fit. Aim 3b): We will include clinic leadership and providers to assess 
climate, clinic readiness, and attitudes towards the intervention, including potential for 
sustainability. This will provide rich contextual and process information for the implementation 
evaluation.
7.3  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
 DESIGN: 
*
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.): (REQUIRED) 
We will implement dCBT in the SFHN focusing on the two clinics that cover most of the Latinx 
patients within the SFHN at ZSFG. Providers will be block randomized by clinic to the 
implementation conditions (i.e., outreach vs. inreach) while patients who enroll to receive dCBT 
will be randomized to two delivery modes (peer-supported vs. unsupported). Our target is to 
enroll 390 LEP Latinx patients.
7.4  
 Briefly provide the background and significance of this study (e.
 BACKGROUND AND SIGNIFICANCE:
*

g. why is this study needed) 
 
(space limit: one half page): (REQUIRED)
Depression and Anxiety Treatment Disparities among LEP Latinxs. Latinxs experience 
increased rates, severity, or persistence of mood and anxiety disorders compared to their non-
Latinx white counterparts (Vilsaint, NeMoyer, & Fillbrunn, et al., 2019; Escovar, Craske, & Roy-
Byrne, et al., 2018). In addition Latinxs with LEP who have depression and/or anxiety disorders 
take longer to receive treatment and when they do, they typically receive lower quality of care 
(Bauer, Chen, & Alegría, 2010; Wells, Klap, Koike, & Sherbourne, 2001). In general, two-thirds of 
people with common mental health issues (e.g., depression and anxiety) want psychological help 
(Brody, Khaliq, & Thompson, 1997; Dwight-Johnson, Sherbourne, Liao D, & Wells, 2000; Bedi, 
Chilvers, & Churchill, et al., 2000; Priest, Vize, Roberts, Roberts, & Tylee, 1996; Churchill R, 
Khaira M, Gretton V, et al., 2000) and ethnic minorities are even more likely to prefer 
psychosocial services to antidepressant medication (Givens, Houston, Van Voorhees, Ford, & 
Cooper, 2007). Latinxs show even higher rates of under-utilization of mental health services than 
whites (31% versus 48% of non-Latinx whites) for various reasons including time constraints, 
transportation problems, availability of services, stigma, and cost (Interian, Ang, Gara, Rodriguez, 
& Vega, 2011; Quality AfHRa. 2016). Additionally, even when Latinx receive mental health 
services, engagement is lower. They are more likely to drop out and receive fewer sessions 
(Chavira, Golinelli, & Sherbourne, et al., 2014), which negatively effects clinical outcomes (Forde, 
Frame, & Hanlon, et al., 2005;  Hansen, & Lambert, 2003; Nieuwsma, Trivedi, McDuffie, Kronish, 
Benjamin, & Williams, 2011). Reasons for lower engagement in Latinxs include a lack of providers 
and unsatisfactory interactions between patients and providers due in part to cultural and 
linguistic differences (EL E, 2019).
Primary care is the de facto treatment setting for the treatment of common mental health issues 
like depression and anxiety (Frank, Huskamp, & Pincus, 2003). Many Latinxs prefer to remain in 
primary care for treatment rather than being referred to specialty mental health providers, they 
also prefer psychosocial options, especially those that improve accessibility such as short-term 
treatments (e.g., single sessions) or tele-therapy (Dwight-Johnson, Lagomasino, & Hay J, et al., 
2010). However, patients treated in primary care are nearly 4 times as likely to receive 
antidepressant medication than psychotherapy (87.0% vs. 23.2%)(Olfson, Blanco, & Marcus, 
2016). Thus, treatment models that increase access to psychosocial interventions in primary care 
might be particularly well-suited to reduce disparities in access and benefits in mental health 
services for Latinx populations (Dwight-Johnson, Lagomasino, & Hay J, et al., 2010).
Spanish-speaking workforce shortages. However, there is an extreme shortage of Spanish-
speaking mental health providers that limits the ability to disseminate psychosocial interventions. 
In California, where our proposed work will take place, 40% of the overall populations is Latinx, 
whereas only 4% of Psychiatrists, 8% of Psychologists, and 24% of Social workers are Latinx 
(Auntré, Karen, Luona, & Peggy, 2016). Therefore, it is not feasible for all who need services in 
Spanish, to receive them. Even when an interpreter is used, Spanish-speakers report feeling less 
comfortable sharing personal information with an English-speaking therapist (Nguyen, 2014). 
Implementation strategies are needed to improve uptake among LEP Latinxs. Warm 
handoffs (i.e., inreach) are commonly implemented to increase engagement in integrated 
behavioral health; however, this approach is less effective among LEP Latinxs (Horevitz, 
Organista, & Arean, 2015). Lack of culturally- and linguistically-concordant providers could be one 
reason for lower effectiveness. Consolidating referrals using a registry-based approach (i.e., 
outreach) could be a more efficient use of Spanish-speaking staff. The available research 
indicates that structural and cultural barriers to care can be addressed through improved 
outreach strategies, which include registry-based case finding and reaching out to and motivating 
patients to seek early and/or sustained care before they arrive in the clinical setting (Yabroff, 
O'Malley, Mangan, & Mandelblatt, 2001; Fuzzell, Perkins, Christy, Lake, & Vadaparampil, 2020). 
In-reach (e.g., clinic-based warm handoffs) and outreach strategies (e.g., registry-based 
identification) have been successfully applied to cancer screening (Fuzzell, Perkins, Christy, Lake, 
& Vadaparampil, 2020) and prenatal care engagement in underserved populations (Guendelman, 
& Witt, 1991). Inreach and outreach each provide benefits and limitations, and it is important to 
understand which works best for engaging LEP Latinx in care. Outreach might be especially 
relevant for interventions that facilitate better direct-to-consumer strategies (Becker, 2015), such 
as digital interventions. Given open questions about effectiveness of inreach and outreach, our 
study will compare these two strategies to promote adoption in low-resourced clinic settings. 
Efficacy of Digital Cognitive-Behavioral Therapy (dCBT). A growing number of trials suggest 
that digital interventions, especially when coupled with human support, can produce reductions in 
symptoms of anxiety and depression that are similar to those seen for psychotherapy and 
pharmacotherapy. A recent meta-analysis of dCBT summarizing 39 studies and 9,571 patients 
found that both supported and unsupported dCBT showed superiority to treatment as usual and 
waitlist controls, and that supported dCBT was superior to unsupported dcBT (Karyotaki, 
Efthimiou, Miguel, et al., 2021). Even in clinic settings, a recent randomized trial comparing a 

coached dCBT platform to treatment-as-usual for anxiety and depression in internal medicine 
clinics found greater reductions in symptoms of anxiety and depression and higher rates of 
recovery among patients who received dCBT (Graham, Greene, & Kwasny, et al., 2020). The 
strength and consistency of support for dCBT has led to recommendations that dCBT should be a 
frontline treatment for anxiety and depression ((NICE) NIfHaCE, 2006; (NICE) NIfHaCE, 2009). 
Examples of successful deployments of dCBT to increase access to effective care can be found 
globally including in Australia (Titov, Dear, Staples, et al, 2017; Titov, Dear, Nielssen, et al, 
2018) and the UK (Duffy, Enrique, Connell, Connolly, Richards, 2019). 96% of Spanish-speaking 
patients in our clinic settings own smartphones, making dCBT a viable delivery mechanism with 
potential for sustainable delivery.
Although many dCBT platforms exist, few of the widely available platforms have undergone 
rigorous empirical evaluations especially in clinical settings. Most evaluations have used a small 
set of users (Moberg, Niles, & Beermann, 2019; Dryman, McTeague, Olino, & Heimberg, 2017) or 
taken place in controlled settings (Parks, Williams, Tugade, et al., 2018). One notable exception 
is SilverCloud. Initial research on the impact and user experience of the SilverCloud platform was 
published in 2012 (Doherty, Coyle, D., Sharry, 2012). Since then, SilverCloud has been used by 
more than 500,000 users and been involved in multiple trials including efficacy trials (Richards, 
Timulak, O'Brien, et al. 2015),pragmatic trials (Duffy, Enrique, Connell, Connolly, & Richards, 
2019; Richards, Enrique, & Eilert N, et al., 2020), and evaluations of adaptations of SilverCloud 
including cultural and linguistic adaptations in Mexico and Colombia in Spanish (Salamanca-
Sanabria, Richards, Timulak, 2019; Salamanca-Sanabria, Richards, & Timulak, et al., 2020). 
SilverCloud is currently being evaluated for college students in Colombia and Mexico (R01 
MH120648, PI: Benjet), and we are currently involved in a PCORI-funded evaluation of guided 
and unguided SilverCloud among Medicaid recipients in West Virginia (PCS-2017C3-9252, PI: 
Bossarte). The choice of a dCBT intervention with strong evidence of efficacy is consistent with 
NOT-MH-18-031 on NIMH high-priority areas for research on digital health to use existing 
commercial digital health applications in NIMH-funded research.
Although human support is recognized as an essential component of the most effective dCBT 
programs, including support significantly reduces the scalability of dCBT. This is especially true for 
traditionally underserved populations, like LEP Latinx, as in most instances human support is 
offered by specialty mental health providers and significant workforce shortages exist. Despite 
this reliance on specialty providers as supporters for dCBT, evidence suggests that with some 
training non-specialty personnel (e.g., technicians, research assistants) can achieve results 
similar to professionals (Titov, Andrews, Davies, McIntyre, Robinson, Solley, 2010). Given the 
dearth of Spanish-speaking providers, reducing the reliance on professionals might increase the 
ability to implement and scale such programs, especially in low-resource settings, and ultimately 
increase their impact.  
Peer-Supported Programs. One evidence-based solution to overcome the limitations (e.g., 
language, scalability, cost) associated with professional support is utilizing peers and lay 
supporters. Peer support might be especially relevant for Latinx patients who report appreciating 
culturally-appropriate care. Such care often integrates factors such as “simpatia” or support 
received by interacting with people who understand and have experience with their sociocultural 
context (Aguilera, Garza, & Muñoz, 2010). Furthermore, the work of peers, including community 
health workers or promotoras in the Latinx community, has been particularly helpful for 
improving access to mental health care in underserved and under-resourced settings (Barnett, 
Gonzalez, Miranda, Chavira, & Lau, 2018; Hoeft, Fortney, Patel, & Unützer, 2018). Although some 
work has found positive responses among stakeholders when trained promotoras are used to 
address social determinants of depression in primary care, improvements in depression symptom 
severity were not found (Waitzkih, Getrich, & Heying, et al., 2011). More recent studies have 
found that promotoras may be helpful in intervention task sharing, improving patient care 
management and engagement in evidence-based behavioral health care, and by understanding 
socio-cultural context in overcoming stigma and for supporting therapeutic alliance, engagement 
and retention in care (Hoeft, Fortney, Patel, & Unützer, 2018). Thus, including peers to support 
mental health service delivery via a dCBT platform combines the evidence-based clinical content 
with increased alliance, engagement, and retention that peers provide.
In California, where this work will be conducted, recent legislation (SB 803) supports the 
certification and payment for peer support specialists in mental health service delivery under Medi-
Cal. This bill aligns with programs in most other states to certify and reimburse for peer support 
specialists. As such, leveraging peers as supporters in dCBT platforms may be a scalable and 
sustainable strategy if demonstrated effective.     
Summary of Significance. Clear treatment gaps exist in access to mental health services, 
especially among LEP Latinx patients. With the increase in remote and digital services related to 
COVID, the potential for digital treatments is beginning to be realized, but the gaps integrating 
such technologies into practice settings, especially to meet the needs of traditionally underserved 
populations are clear. We need implementation strategies tailored for delivery of digital care and 

service delivery models that can overcome workforce limitations such that inequities are not 
merely repeated in a digital medium. dCBT is a best-in-class, evidence-based, digital intervention 
and SilverCloud is one of the most researched commercial examples of dCBT. However, 
consistent with this PA, there is a need to determine the effectiveness of strategies to deliver 
evidence-based treatments in low-resource and non-specialty settings where evidence-based 
practices are not currently being delivered. This study focuses on these questions in digital care 
delivery and implementation.
7.5  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
Previous work in Digital Interventions in Latinx Primary Care Mental Health. Our team 
has conducted extensive work implementing culturally-relevant CBT and digital interventions in 
primary care settings in the public sector among Spanish-speaking populations (Aguilera, Garza, 
& Muñoz, 2010; Aguilera, & Muñoz, 2011; Aguilera, & Berridge, 2014; Aguilera, Bruehlman-
Senecal, Liu, & Bravin, 2018; Garcia, Ochoa-Frongia, Moise, Aguilera, & Fernandez, 2018; 
Aguilera, Ramos, Sistiva, Wang, & Alegria, 2018). We have shown that engagement in depression 
treatment is a challenge for patients in public sector primary care clinics (Aguilera, Bruehlman-
Senecal, Liu, & Bravin, 2018).Dr. Aguilera developed and tested an automated text messaging 
adjunct to the BRIGHT group depression treatment among Spanish speakers with depression 
resulting in increased engagement ( Aguilera, & Muñoz, 2011; Aguilera, & Berridge, 2014; 
Aguilera, Bruehlman-Senecal, Demasi, Avila, 2017).This foundational work showed that LEP 
Latinx can and will engage with digital interventions. 
Drs. Aguilera and Lyles are currently conducting a study using a mobile app-based intervention to 
increase physical activity among patients with depression and diabetes. They have demonstrated 
how technology-based interventions can be designed for underserved populations (Aguilera, 
Bruehlman-Senecal, Demasi, & Avila, 2017; Avila-Garcia, Hernandez-Ramos, & Nouri, et al., 
2019; Nouri, Avila-Garcia, Cemballi, Sarkar, Aguilera, Lyles, 2019) and have recently gained 
experience conducting remote recruitment for research studies due to the COVID-19 pandemic.
Dr. Fortuna has extensive experience conducting trials of digital programs in health care settings. 
Her work has highlighted the importance making the burden on providers low, while integrating 
training in technology use in supported digital interventions. We are including all of these aspects 
into our trial, including our peer training and support protocol. Last, her interviews showed that 
during COVID-19 pandemic participants have had an opportunity to use and become more 
comfortable with telepsychiatry and virtual care.
Previous work in Supported dCBT. Dr. Schueller has extensive work in the development, 
evaluation, and implementation of dCBT, including for LEP Latinx patients. He was a co-I on two 
recently completed trials of dCBT for depression (R01 MH100482, R01 MH095753), and is a co-I 
on a recently funded trial of dCBT for depression among cancer patients with a specific focus on 
Latinx patients (R37 CA255875). The two completed randomized trials found that dCBT was 
effective at reducing depression and anxiety (Mohr, Lattie, Tomasino, et al., 2019; Mohr, 
Schueller, Tomasino, et al., 2019) and also that stepped care using dCBT was noninferior to 
telephone CBT, demonstrating comparability with other forms of CBT delivery, and that it was 
significantly less costly, mostly due to reduced therapist time (Mohr, Lattie, Tomasino, et al., 
2019), demonstrating promising potential for sustainability.Both of these studies involved 
supported dCBT and the coaching support manual (Tomasino, Noth, Bardsley, Lattie, Mohr, 2016) 
from these studies will be used for this proposed SUPERA study (although translated into 
Spanish). The support manual is based on the supportive accountability model (Parks, Williams, & 
Tugade, et al., 2018) and the efficiency model ((NICE) NIfHaCE, 2006) (developed by PI 
Schueller). The efficiency model forms our conceptual model for evaluating the patient-level 
effectiveness (Aim 1; clinical outcomes of depression and anxiety; adherence is patient adoption) 
and understanding the putative mechanisms of support (Aim 3a). Specifically, we will assess 
relational factors including bond, accountability, and legitimacy and technique factors including 
skill fit (i.e., cultural relevance and effectiveness), skill use, and knowledge (CBT skill knowledge).
This work shows our capacity to conduct clinical trials of dCBT, to train and supervise supporters, 
and provides the conceptual model that elucidates our change mechanisms hypothesized to 
account for intervention effects. 
Dr. Schueller leads the Implementation Evaluation Core for the Help@Hand Evaluation Team. 
Help@Hand is a multi-year innovation project representing a collaboration between 14 California 
city and county behavioral health departments to explore the use of technology to improve the 
reach and impact of mental health services. As part of this project, Dr. Schueller has designed 
and conducted multi-level, mixed-methods evaluations including interviews, surveys, and 
workflows observations. Within this project a recent pilot explored the use of dCBT to enhance 
wellbeing and social connectedness among isolated older adults. This pilot consisted of 30 isolated 

older adults, half of which were monolingual Spanish speakers. The English speakers were 
supported by nurse interns and the Spanish speakers were supported by promotoras. A majority 
of these participants found dCBT useful (74%), easy to use (65%), and would recommend it to 
someone else (78%). Furthermore, they found dCBT to be a culturally-appropriate treatment 
(78%).  Supporters found dCBT to be usable (73%), safe (100%), and useful (80%) for their 
clients, and appropriate for their work (67%). However, interviews identified opportunities for 
improvement including additional orientation to the dCBT platform, guidance to fit its use into 
their busy lives, and further opportunities for enhanced cultural tailoring. These issues will be 
addressed using our peer support protocol.
7.6  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED)
 Yes  
 No
7.7  
 Does this study involve any procedures, lab tests or imaging studies that 
* BILLABLE PROCEDURES:
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other 
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
  Yes  
  No
, send 
If you are not sure if your study involves billable procedures
an email to the 
 for help 
UCSF Office of Clinical Research (OCR)
answering this question.
7.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above
7.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
Describe the research methods and study activities taking place at each site 
(e.g. what will participants be asked to do and what will members of the 
study team do?). If there will be multiple participant groups or study sites, 
explain what will happen with each group or study sites.
 

If some of the activities would occur even if the person were not in the 
study, as in the case of treatment or tests performed for diagnostic 
purposes, clearly differentiate between those activities that will be 
done solely for research purposes and those that are happening as 
part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts 
are research and what parts aren't.
Our dCBT intervention will be announced to PCPs and behavioral health clinicians in participating 
clinics along with education about inclusion and exclusion criteria. Our first level of randomization 
will be at the provider level. Patients will be recruited in two ways: 1) For providers who are 
randomly assigned to “outreach” our team will use the registry for recruitment. A study team 
member will contact PCPs with a list of their patients eligible for inclusion to seek their approval 
to recruit patients, send a letter and will then contact eligible patients to offer the intervention. 
Additionally, patients identified as eligible through the registry will receive a flag in the EHR so 
that the provider can introduce the study to them, and 2) For providers who are randomly 
assigned to the “inreach” condition any patient of the providers in this condition may be referred 
for dCBT by their PCP or corresponding behavioral health clinician and our team will confirm 
eligibility. 
Outreach. Outreach will be a direct-to-patient implementation strategy that will leverage the 
patient registry at ZSFG. This registry is based on patient- and provider-reported data and 
demographics in the Epic electronic health record (EHR). Registry reports can be pulled based on 
validated population health management tools in Epic, specifically the Healthy Planet tool. These 
reports include patient demographics and primary care provider problem list diagnoses and visit 
diagnoses and any structured assessment data including PHQ-9 (Patient Health Questionnaire-9) 
and/or GAD-7 (Generalized Anxiety Disorder 7). Thus, preference for Spanish, a diagnosis of 
depression or anxiety on the problem list or visit summary or PHQ-9 and/or GAD-7 scores will all 
be available on these reports. In the outreach strategy, potentially eligible patients will be 
identified and contacted. First mode of contact will be through a letter presenting the study, sent 
on behalf of the research team by the patient’s clinic, providing information about how to opt out 
of further contact, prior to phone contact by the research team. This will be followed by a scripted 
phone call providing an introduction to SilverCloud. These phone calls will be followed by a video 
call orientation or a letter from the clinic, culturally-tailored introduction to SilverCloud, and a 
referral to receive login instructions. SilverCloud’s integration with Epic EHR will make referral and 
data collection streamlined. Research team will attempt to contact eligible participants a total of 3 
times. 
Inreach. Inreach will be a clinic-based implementation strategy that will consist of a referral by 
one’s primary care provider or behavioral health team clinician at the time of a usual care visit. 
Eligible patients will be identified by a flag in the EHR and additionally primary care providers will 
be presented with orientation to the study and study referral materials in regular clinical huddles. 
Primary care providers will provide the same referral materials provided in the outreach condition 
(cover letter from clinic, culturally-tailored introduction to SilverCloud, referral for login 
instructions). In usual care at ZSFG, there are both 1) warm handoffs between primary care and 
behavioral health clinicians for mental health treatment, and 2) ongoing mental health care 
provided by the primary care team. In both instances of usual care, we will be able to provide 
hardcopy materials to enrolled providers to distribute to their panels as the study progresses. 
These materials will be refreshed by research staff attending regular clinical huddles on a monthly 
basis.
The second level of recruitment will happen once participants have enrolled in the study. They will 
be randomized into the unsupported dCBT or Peer-Supported dCBT. 
Unsupported dCBT. Unsupported dCBT provides all features of the SilverCloud platform with the 
exception of the peer support (structured support from peer and share features). Patients will be 
provided free access to SilverCloud and instructed to use it for 8-weeks. Patients will receive 
weekly automated messages to encourage engagement.  We have used this same strategy in our 
PCORI study as it is scalable and sustainable without a significant investment of resources.
Peer-supported dCBT. In the peer-supported dCBT condition, in addition to the SilverCloud 
platform each patient will be assigned a peer-supporter who will provide regular support based on 
our coaching support manual. Following our supporter protocol developed in our previous dCBT 
studies supporters will conduct a brief engagement call (30-40 minutes) to provide an overview of 
SilverCloud, identify goals and set expectations, introduce themselves, and orient the participant 

to the role of the peer supporter. Supporters will then provide weekly check-ins through phone 
calls or messaging. The goals of weekly check-ins are to identify and resolve potential barriers 
outlined in the Efficiency Model (usability, engagement, knowledge, fit, and implementation) and 
to monitor symptom severity and progress. Participants will be able to communicate with the 
supporters through the platform through messaging or sharing activities for additional discussion. 
It is worth noting that this type of support is not conceptualized as a treatment, but rather 
intended to increase engagement with and impact of the evidence-based treatment, which is the 
dCBT platform. Therefore, although these peers will be trained with knowledge of the platform, 
the major goal of these peers is to promote use of the platform. Supporters will also be trained in 
crisis management protocols and supervised appropriately.  We will monitor fidelity to the support 
protocol through recordings of phone calls and their use of the supporter dashboard (Aim 3a). 
Peer Recruitment, Training, and Protocol. Peers will be recruited from local community 
organizations (Somos Esenciales) as well as from previous graduates of the BRIGHT Group 
Cognitive-Behavioral Therapy for Depression treatment, a 16-session group CBT treatment that 
has been delivered by Dr. Aguilera at ZSFG (Miranda, Woo, Lagomasino, Hepner, Wiseman, 
Munoz, 2006). Interested supporters will participate in 8 hours of in-person or remote training led 
by Drs. Aguilera, Schueller, and Kimberly Marquez-Cortes (consultant). This training will be 
adapted from the training we have provided to coaches in our recent coach-supported trials 
(Lattie, Ho, Sargent, et al., 2017; Tomasino, Lattie, Ho, Palac, Kaiser, Mohr; Mohr, Tomasino, 
Lattie, et al., 2017). The supporters will be trained on our coaching support protocol that details 
instructions for conducting an engagement phone call, monitoring participants’ use of SilverCloud 
(i.e., the frequency, content, examples of weekly messages) and handling FAQs, crises, and 
escalation. The training will also include a thorough overview of SilverCloud. Each supporter will 
receive a guidebook that includes description of the key features of SilverCloud, the procedures 
for the engagement phone call and follow-up messaging, including examples of how to conduct 
these sessions and sample messages. During the intervention, supporters will be expected to 
make 1 engagement phone call at the beginning of a user’s participation lasting approximately 30-
40 minutes and to compose 2-3 engagement messages per week through secured messaging. 
Supporters will be compensated for their time dedicated to training activities and all study 
procedures at market rate. Supporters will also receive regular supervision. Additional supporters 
will be onboarded as needed due to supporter turn-over and patient recruitment. We will also 
have a Peer Support Advisory Committee consisting of consultants Marquez-Cortes, Camarena, 
Flores, and Ubozoh) that will meet quarterly to support recruitment of peers, provide guidance on 
the training, implementation, and evaluation of our peer-support protocol, and including 
interpreting our findings with a lens towards sustainability in future projects (e.g., linkage to peer 
support certification and payment). 
Providers and peers involved in the study do not meet the definition of human subjects for this 
research. Peers will also receive CITI training. 
For patient participants, we will review the record for PHQ-9 and GAD-7 ratings and or changes in 
depression or anxiety diagnosis during the time of the study. 
SilverCloud Appendix attached in under other study documents 
Staff at UC Berkeley have joint appointments with UCSF. UC Berkeley personnel will interact with 
human subjects (recruitment) and have access to identifiable data. 
UCI will not interact with human subjects or any identifiable data. 
7.10  
: To what extent, if any, do the planned research procedures differ 
 STANDARD CLINICAL PRACTICE
*
from the care that people would otherwise receive at this institution or the study site if not being 
done locally: (REQUIRED)
 
There is a standard protocol for identification, brief intervention, and referral for people who 
screen positive for depression and/or anxiety. However, the study site has limited Spanish 
speaking providers so referral is the most likely option. 

7.11  
List all questionnaires, surveys, interview, or focus group guides that will be used 
INSTRUMENTS: 
* 
for this study: (REQUIRED)
If the instruments are not complete or not available because they will be 
developed as part of this study, describe the basic content or include an 
outline and submit the final versions to the IRB with a modification for 
approval prior to use.
All assessments will be administered in Spanish. Online assessments will be sent first via our 
secure online assessment platform (REDCap79, which is made available and supported through 
UCSF’s CTSI). Participants who fail to complete the online assessment will be provided a reminder 
within a one-week window before being contacted by phone with the option of completing a 
telephone assessment. Assessments will occur at baseline, week 8 (end-of-treatment), and at a 3-
month post-treatment follow-up. 
We will assess several participant characteristics including sex, age, education, acculturation, 
technology literacy, and previous and current use of mental health services. In addition to 
standard ethnicity questions, participants will be asked to indicate their national origin or 
ancestry, years in the US. Acculturation will be assessed by the Brief Acculturation Scale for 
Hispanics and by nativity status/length of time in the US. Technology literacy will be assessed 
using the Internet and Mobile Usage Patterns and Internet and Mobile Self-Efficacy Scales we 
have developed.   
List of measures are as follows:
1. PHQ-9
2. GAD-7
3. Semi-Structured Interview Guide
4. Supportive accountability measure
5. Working Alliance Inventory
6. Frequency of Action and Thoughts Scale
7. Knowledge Gain in dCBT
8. Acceptability, Appropriateness, Feasibility Measure (IAM/AIM/FIM)
9. Implementation Climate Scale
10. Organizational Readiness for Change
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
7.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future 
research: (REQUIRED)
  Yes  
  No
7.13  
Briefly summarize the methods and types of analyses that will be 
 STATISTICAL METHODS: 
*
performed: (REQUIRED)
All analyses will be conducted based on intention-to-treat principles; we will use mixed-effects 
models adjusting for the intra-clinic correlation. Additionally, we will include participant 
characteristics including sex, age, education, type of Latinx group, acculturation, technology 
literacy, and previous use of mental health services as covariates. We will also explore baseline 
severity of symptoms of depression and anxiety and each peer supporter as potential moderators 
of treatment response. 
Clinical Effectiveness (Aim 1). The primary clinical outcome for this trial is symptoms of 
depression and anxiety. We will compare PHQ-9 and GAD-7 scores between the conditions using 
mixed-effects models. Mixed-effects models generally require three time points which is why we 
include a post-treatment assessment at 3-months. Although every effort will be made to avoid 
missing data (e.g., e-mail/text reminders for assessments, financial incentives for completing 

assessments), mixed-models are robust to missing data. Mixed-effects models do not require 
complete case data (i.e., at every time point); thus, even participants with missing data at some 
assessments are included in the analysis and results are modeled on the basis of the available 
data. In the case of missing data, we will also analyze if missing data is related to any observable 
characteristics. Secondary clinical outcomes for this trial will consist of the PROMIS Social Health 
and clinical outcome data collected from the SilverCloud platform also analyzed using mixed-
effects models.  
Use of Platform (Aim 1). Secondary outcomes will include measures of use as defined as time on 
platform. We will compare use across the two arms of the study using implementation strategy as 
a potential covariate (to determine if adherence differs across strategies). Mediational analysis. 
We will also explore whether use of the platform mediates changes in clinical symptoms. 
Mediation will be examined using a bootstrapping procedure (Preacher, Hayes, 2008). We will 
compute different models for activity from users of the platform as well as by supporters of the 
platform. 
Implementation Outcomes (Aim 2). We will compare the proportion of patients referred, initiating, 
and completing treatment at each of the clinic sites using mixed-effects models using these 
proportions as continuous outcome variables. These models will allow us to control for intraclinic 
clustering of providers as well as patient characteristics of each clinic. Patient demographics and 
costs of treatment between arms will be compared using ANCOVAs controlling for clinic and 
patient characteristics. 
7.14  
List only the 5-10 most relevant references (a separate bibliography can be attached 
 REFERENCES: 
*
 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with): (REQUIRED)
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toward mental health treatment and service use differs by age, gender, ethnicity/race and 
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Health Treatment Among Latinos in 2 Different Host Countries: The United States and Spain. J 
Public Health Manag Pract. 2017;23(1):e20-e27.
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4.    Sentell T, Shumway M, Snowden L. Access to mental health treatment by English language 
proficiency and race/ethnicity. J Gen Intern Med. 2007;22 Suppl 2:289-293.
5.    Bauer AM, Chen CN, Alegría M. English language proficiency and mental health service use 
among Latino and Asian Americans with mental disorders. Med Care. 2010;48(12):1097-1104.
6.    Kazdin AE, Blase SL. Rebooting Psychotherapy Research and Practice to Reduce the Burden 
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primary care with evidence-based practice. Psychiatr Serv. 2003;54(5):682-687.
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8.0
 Drugs and Devices
8.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No

If you have questions about FDA requirements for drug or device 
research, you can send an 
to request a consult.
email 
8.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
  Yes  
  No
If you have questions about FDA requirements for drug or device 
research, you can send an email to request a consult.
9.0
 Sample Size and Eligibility Criteria
9.1  
How many people will you enroll: 
ENROLLMENT TARGET: 
* 
(REQUIRED)
426
 If there are multiple participant groups, indicate how many people will be 
in each group:
                                                                        
Approximately 426 participants will be recruited to participate.
                                                       
    
9.3  
Explain how and why the number of people was chosen. For multi-
 SAMPLE SIZE JUSTIFICATION: 
*
site studies, this is referring to the number that will be enrolled across all sites: (REQUIRED)
The sample size was determined based on comparisons between intervention conditions (peer-
supported vs. unsupported) regarding effectiveness. With a conservative estimate based on the 
meta-analytic findings (Karyotaki E, Efthimiou O, Miguel C, et al., 2021) of being able to detect a 
two-point difference in change on the PHQ-9 or GAD-7 between treatment and control group at 
an α = .05, we would need 300 participants (150 per condition) to achieve power of 90%. We 
also estimate 25% non-use attrition (e.g., participants complete assessment measures, but do 
not use the platform, therefore reducing the effect) in the peer-supported group and 29% non-
use attrition in the unsupported group again based on meta-analytic estimates,39 therefore our 
estimate of 390 total patient participants (195 per condition) would achieve excellent statistical 
power on Aim 1.
We have re-run our power analysis adjusting for intra-clinic and intra-provider correlations and an 
adjusted alpha level of = .025, assuming an ICC of 0.3 we would need 167 participants per 
condition to achieve 80% power or 426 total participants adjusting for our proposed attrition rate. 
We can update our recruitment goal from 390 (which would have had 75% power with these 
additional considerations) to 426 participants.
9.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)

Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
9.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Adult subjects unable to consent for themselves
Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
If not already addressed in the Background and Significance questions in 
the Research Plan section or elsewhere, explain why it is appropriate to 
include the types of subjects checked above in this particular study:
                                                                        
These patient's need access to quality care therefore we would like to study if technology can be 
used to include care to underserved public sector patients.
Consent forms will be available in both electronic and paper based forms. Electronic consent 
forms will be sent to participants via DocuSign. Based on our prior experience, many consent 
forms will come from wet signatures. 
                                                       
    
Describe the additional safeguards that have been included in the study to 
protect the rights and welfare of these subjects and minimize coercion or 
undue influence:
Here are some examples:
evaluating capacity to consent for individuals who may be decisionally 
impaired (specify how)
calibrating payment amounts to be non-coercive for the financially 
disadvantaged
conducting more in-depth evaluations of subjects’ understanding of 
the study and the voluntary nature of participation
involving advocates in the consent process
More information and other safeguards are described here: Vulnerable 
 and 
.
Subject Populations
Recruiting Staff and Students
                                                                        

We are ensuring that RA’s are bilingual and can clearly communicate risks and benefits of the 
study. Electronic consent form and other study documents will be available and offered in the 
subject’s primary language. Personnel will be made available and able to discuss participation in 
the patient’s language for the consent process.
                       
Additionally, program staff will available to provide all participants with electronic or printed 
information sheet that outlines the study activities and the rights of participants and will explain 
this information fully, allowing participants to ask questions before they decide to participate and 
give informed consent. All participants will be informed that they are not obligated to participate, 
can decline to answer questions or opt out of study activities at any time, and can leave the study 
at any time without threat of loss of access to any medical services to which they are normally 
entitled.
                       
All participants will receive $25 for participation in these interviews regardless if they completed 
participation in the intervention. Compensation is enough to respect their time but not overly 
coercive so that it is the primary motivator.
                                                       
    
9.7  
 Briefly describe the population(s) that will be involved in this study. Include 
 INCLUSION CRITERIA: 
*
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, providers, 
administrators, students, parents, family members, etc.): (REQUIRED)
All participants must meet the following criteria: 
1) PHQ-9 ≥ 10 or GAD-7 ≥ 8, 
2) access to the Internet via smartphone (91% ownership in Dr. Aguilera’s MoodText study and 
96% in DIAMANTE study in same setting) or broadband at home, and basic level of digital literacy 
or willingness to undergo a digital literacy training,
3) ≥18 years of age,
4) preference for receiving medical care in Spanish, 
5) not in concurrent psychotherapy and, 
6) if currently taking an antidepressant medication, patient must have been on a stable dose for 
at least 6 weeks, and have no plans to change the dose. We will permit patients on 
antidepressants to enter the study, as this will increase generalizability. Antidepressant status will 
be assessed to control for those effects, if necessary.
9.8  
 List any exclusion criteria (e.g. reasons why someone would not be included 
 EXCLUSION CRITERIA:
*
in the study): (REQUIRED)
1) currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for 
depression and anxiety, however, patients are allowed to be referred to treatment while 
participating in this study and initiation of treatment will be monitored and considered in 
analyses, 
2) visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study 
procedures, 
3) diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use 
disorder, 
4) severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). Although 
procedures with back-up plans are in place for patients who develop suicidality, patients assessed 
with severe suicidality will be referred to more-intensive treatment resources.  
9.9  
Do any study activities take place on any patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
care units including inpatient wards, peri- or post-operative care units, operating rooms, or in the 
 
Emergency Department at UCSF Health medical facilities: (REQUIRED)

  Yes  
  No
9.11  
Does your protocol or study involve any of the following patient related 
EMERGENCY DEPARTMENT: 
* 
activities in the emergency department (e.g. subject identification, recruitment, consent, blood 
draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any other ED 
based procedures): (REQUIRED)
 
  Yes  
  No
10.0
 Recruitment and Consent
10.1  
Is this a competitive enrollment clinical trial? By competitive 
* COMPETITIVE ENROLLMENT: 
enrollment, we mean that sites who do not enroll participants early may not get to participate at all: 
(REQUIRED)  
  Yes  
  No
10.2  
 
What kinds of methods will be used to identify potential 
* SUBJECT IDENTIFICATION METHODS: 
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic, 
scheduled for surgery, a procedure, imaging, or tests, or seen in the Emergency Department 
as well as searching through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial website
Other method (describe below)
* Provide details about the subject identification methods: (REQUIRED)
Outreach will be a direct-to-patient implementation strategy that will leverage the patient registry 
at ZSFG. This registry is based on patient- and provider-reported data and demographics in the 
Epic electronic health record (EHR). Registry reports can be pulled based on validated population 
health management tools in Epic, specifically the Healthy Planet tool. These reports include 
patient demographics and primary care provider problem list diagnoses and visit diagnoses and 
any structured assessment data including PHQ-9 (Patient Health Questionnaire-9) and/or GAD-7 
(Generalized Anxiety Disorder 7). Thus, preference for Spanish, a diagnosis of depression or 
anxiety on the problem list or visit summary or PHQ-9 and/or GAD-7 scores will all be available 
on these reports. In the outreach strategy, potentially eligible patients will be identified and 
contacted. 
First mode of contact will be through a letter presenting the study, sent on behalf of the research 
team by the patient’s clinic, providing information about how to opt out of further contact, prior 
to phone contact by the research team.
Inreach will be a clinic-based implementation strategy that will consist of a referral by one’s 
primary care provider or behavioral health team clinician at the time of a usual care visit. Eligible 
patients will be identified by a flag in the EHR and additionally primary care providers will be 
presented with orientation to the study and study referral materials in regular clinical huddles. 

Primary care providers will provide the same referral materials provided in the outreach condition 
(cover letter from clinic, culturally-tailored introduction to SilverCloud, referral for login 
instructions).
10.3  * SEARCHING OF MEDICAL RECORDS: (REQUIRED)
Whose patients are they:
Investigators' own patients or patients seen within the same practice
Patients not under the care of the investigators
How and by whom will records be accessed and searched (check all that 
apply):
Self-search in APeX or other medical records source
Self-search using UCSF's Research Cohort Selection Tool
CTSI Consultation Service Recruitment Services
UCSF Academic Research Services (ARS)
University of California Research Exchange (UC ReX)
Other method (describe below)
Describe the other ways medical records may be accessed and searched to 
identify prospective participants:
                                                                        
To determine eligibility of patients participating, research staff will generate through the 
electronic health record lists of patients meeting the following criteria: patients at RFPC or FHC; 
Spanish-speaking; age 18+; PHQ-9 ≥ 10 or GAD-7 ≥ 8. A study team member will contact PCPs 
with a list of their patients eligible for inclusion to seek their approval to recruit patients and will 
then contact eligible patients to offer the intervention.  Additionally, patients identified as eligible 
through the registry will receive a flag in the EHR so that the provider can introduce the study to 
them, and for providers who are randomly assigned to the “inreach” condition any patient of the 
providers in this condition may be referred for dCBT by their PCP or corresponding behavioral 
health clinician and our team will confirm eligibility.
                                                                        
                                                       
    
10.4  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
* 
determined: (REQUIRED)
To determine eligibility of patients participating, research staff will generate through the 
electronic health record lists of patients meeting the following criteria: patients at RFPC or FHC; 
Spanish-speaking; ≥18 years of age; PHQ-9 above 10 or GAD-7 above 8. Potential participants 
will be contacted either by the inreach or outreach strategy. For participants whose providers are 
assigned to outreach, we will receive monthly reports using the registry to identify positive 
depression (PHQ or depression diagnosis) and anxiety (GAD or anxiety diagnosis) screens. For 
participants whose providers are assigned to inreach we will provide monthly reminders to 
providers including reports on the numbers of patients referred and enrolled.
Providers’ assessment of eligibility will be limited to a general initial assessment of potential 
eligibility based on the list provided and their knowledge of the patients, and the research team 
will be responsible for confirming the full eligibility criteria once the provider has referred a 
potential participant to them. Staff will then contact patients via phone or in-person in the clinics 
to assess additional eligibility criteria, including access to the Internet via smartphone or 
broadband at home, basic level of digital literacy or willingness to undergo a digital literacy 
training, preference for receiving medical care in Spanish, not in concurrent psychotherapy and, if 
currently taking an antidepressant medication, patient must have been on a stable dose for at 
least 6 weeks, and have no plans to change the dose. We will permit patients on antidepressants 
to enter the study, as this will increase generalizability. Antidepressant status will be assessed to 
control for those effects, if necessary.

10.5  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
Provide details about how contact is initiated:
                                                                        
First mode of contact will be through a letter presenting the study, sent on behalf of the research 
team by the patient’s clinic, providing information about how to opt out of further contact, prior 
to phone contact by the research team.
Trained research staff will recruit patients via phone who meet eligibility (out-reach). Eligible 
patients flagged in the EHR will be introduced and referred to the study by their provider (in-
reach).
10.6  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study 
Documents section of the Initial Review Submission Packet Form. If 
potential participants will initiate contact, attach the telephone 
screening script that will be used to provide more information about 
the study and determine if callers are eligible to participate.
10.7  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
                                                                        
Provider pre-approved list will be sent to recruitment team. After assessing eligibility via chart 
review, trained research staff will contact patients via phone. Outreach phone call will provide an 
introduction to SilverCloud. These phone calls will be followed by a video call orientation or a 
letter from the clinic, culturally-tailored introduction to SilverCloud, and a referral to receive login 
instructions. 
For providers who are randomly assigned to the “inreach” condition any patient of the providers 
in this condition may be referred for dCBT by their PCP or corresponding behavioral health 
clinician and our team will confirm eligibility.
                                                       
   
    
10.8  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)

Sign a paper consent form at the end of the consent discussion (signed consent)
Sign an electronic consent form using DocuSign or REDCap’s e-signature function (signed 
consent)
Provide online unsigned consent through an app, a website, or a survey tool such as Qualtrics 
or REDCap (waiver of signed consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent - waiver of signed consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent - waiver of signed 
consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not able to provide consent (emergency medicine, greater than minimal risk waiver/alteration 
of consent - requires an approved community consultation plan)
Not able to provide consent (emergency medicine, minimal risk waiver/alteration of consent)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent 
text in the Informed Consent Documents section of the Initial 
Review Submission Packet Form.
Use of the FDA-compliant (also called "Part 11 Compliant") version 
of DocuSign and REDCap is recommended for research consent.
To use FDA-compliant DocuSign, submit an access request at 
https://ucsf.service-now.com/ucsfit and contact it-cloudapps@ucsf.
edu with questions. For the FDA-compliant version of REDCap 
(“REDCap Premium”), go to https://redcap-prem.ucsf.edu and 
contact Academic Research Systems Support with questions. 
More information on electronic consent options for research is 
available online in FAQ #2.
10.9  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)   We encourage researchers to review our 
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
Patients will be given an opportunity to read through the consent form and HIPAA form, and 
study personnel will review the forms with them. Patients can ask any questions they have then. 
Once their concerns have been clearly addressed, they will be asked to explain their 
understanding of the purpose of the study and what they will be asked. If they understand the 
study procedures and are still comfortable with participating, they will be asked to sign the 
written consent form and HIPAA form. If they do not seem to fully understand the study 
procedures, we will continue reviewing the procedures with them and clarify any questions.
Consent forms will be available in both electronic and paper based forms. Electronic consent 
forms will be sent to participants via DocuSign. Based on our prior experience, many consent 
forms will come from wet signatures. 
                                                       

 It is important that the people obtaining consent are qualified to do so. 
*
Briefly describe the training and experience these individuals have in 
obtaining informed consent: (REQUIRED)
                                                                        
Research staff have experience and training obtaining consent in different research studies. 
Additional training specific to this study will ensure research staff are qualified to obtain informed 
consent. All staff possess CITI training.
                                                       
    
10.10  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider 
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining 
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended 
questions about the nature of the study or the experimental treatment, the risks and benefits 
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their 
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary 
nature of participation (especially appropriate when the consent process happens online or 
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another 
method to assess comprehension:
10.11  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 
researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
10.12  
: Indicate which 
 you will use to consent non-English 
NON-ENGLISH CONSENT METHOD
* 
method(s)
 
speaking subjects: (REQUIRED)
Preferred Method—Consent form and other study documents will be available in the subject’s 
primary language Personnel able to discuss participation in the patient’s language will be 
present for the consent process.
Short-Form—A qualified interpreter will translate the consent form verbally, and subjects will 
be given the Experimental Subject’s Bill of Rights in their primary language, following 
instructions in Those Who do not Read, Speak or Understand English for required witnessing 
and signatures
Explain how you will maintain the ability to communicate with non-English 
* 
speakers throughout their participation in the study: (REQUIRED)
                                                                        
Clinicians and study researchers are bilingual/bicultural. Enrollment materials will be available in 
Spanish.
                                                       
    
10.14  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
Participants will come in for a pre and post interviews that will each take approximately 45-60 
minutes each. The time commitment during the study will vary by participant's level of 
engagement. There are multiple exercises that can be completed on the app, and participants will 

have the option to use it as desired.  We estimate the minimum amount of time spent would be 
35 minutes [per week] or 1 hour [per week] for those receiving peer support. Participants can 
spend more time on the app if desired.           
During the intervention, supporters will be expected to make 1 engagement phone call at the 
beginning of a user’s participation lasting approximately 30-40 minutes and to compose 2-3 
engagement messages per week through secured messaging. 
Trial participants will be in the study for 20 weeks. 8 weeks in the dCBT and will receive a 3-
month follow up. 
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
10.15  
Is there a standard of care (SOC) or usual care that would be offered 
ALTERNATIVES: 
to prospective participants at UCSF (or the study site) if they did not participate in this research 
study:
 Yes  
 No
Describe the care that patients would ordinarily receive at the medical 
center if they did not participate in this study (provide details, assuming 
that some of the IRB members are not specialists in this field):
Patient will continue to receive their usual care with their primary care provider 
10.16  
Is the study drug or treatment available off-study:
OFF-STUDY TREATMENT: 
Yes 
No  
Not applicable 
10.17  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
                                                                        
Participants will be able to choose whether or not to participate in the study and will receive 
treatment as usual.
                                                       
    
11.0
 Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when medical records may be reviewed to 
determine eligibility for recruitment.
11.1  
Study personnel need to access 
* PRACTICABILITY OF OBTAINING CONSENT PRIOR TO ACCESS: 
protected health information (PHI) during the recruitment process and it is not practicable to obtain 
informed consent until potential subjects have been identified: (REQUIRED)
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no

11.2  
 
A waiver for screening of health records to identify potential subjects poses no 
* RISK TO PRIVACY: 
more than minimal risk to privacy for participants:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
11.3  
Screening health records prior to obtaining consent will not adversely affect 
* RIGHTS/WELFARE: 
subjects' rights and welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
11.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* IDENTIFIERS: 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
11.5  
 
Describe any health information that will be collected prior to obtaining 
* HEALTH INFORMATION: 
informed consent:
                                                                        
In order to screen patients for eligibility for recruitment, charts will be reviewed for medical 
diagnosis or clinical notes of depression and/or anxiety.
                       
    
Note: HIPAA requires that you collect the minimum necessary.
11.6  
Describe your plan to destroy any identifiable data 
* DATA RETENTION/DESTRUCTION PLAN: 
collected to determine eligibility for recruitment. This should be done at the earliest opportunity. If 
you plan to retain identifiable recruitment data, provide the justification for doing so:
                                                                        

Screening of health records will yield a list of patients eligible for recruitment. This list will be 
stored with a password on a secure UCSF network and will only be accessed by study staff. 
Identifiable data from this list will be deleted from the computer after eligibility is determined for 
each patient.
                                                       
    
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a 
threat to self or others that they are required to report
For reportable information, include details of the reporting plan below. (See 
the Help link for Mandated Reporter child and elder abuse resources.)
For any boxes checked above, describe how you will minimize these risks 
* 
and discomforts, e.g., adding or increasing the frequency 
of monitoring, additional screening to identify and exclude people with 
diminished kidney or liver function, or modification of procedures such as 
changing imaging studies to avoid giving contrast agent to people who are 
more likely to suffer side effects from it, etc.: (REQUIRED)
Risks associated with research assessments: All responses to assessment questions are 
voluntary; participants are told that they can decline to answer any questions that they choose 
and are under no obligation to answer any questions they are not comfortable with. The 
instruments and methodologies are well-tested and are not known to cause problems or distress 
on the part of the participants. In this trial, participants will answer the PHQ item 9 which 
addresses thoughts of death or self-harm. If participants indicate a value > 0, they will receive a 
list of crisis support services within the assessment or SilverCloud platform (which is consistent 
with the safety monitoring plan of SilverCloud), and the PIs (Dr. Schueller and Dr. Aguilera) will 
receive an automated message that will be addressed within 24 hours. A study assessor will 
contact the participant to complete a suicide risk assessment will be conducted using the 
Columbia-Suicide Risk Assessment. In addition, the assessor will assess for support plan and level 
of imminence. If participant level of risk is assessed as severe the assessor will alert the clinical 
supervisor (Dr. Aguilera or assigned clinical supervisor), explain duty-of-care to participant, and 
follow a guided crisis procedure protocol. 
The crisis procedure protocol involves: 
(1) restating duty of care, 
(2) confirming landline and mobile number, 
(3) confirming address and current location, 
(4) contact the clinical supervisor/team leader, 
(5) call 911 emergency services, 
(6) keep participant on phone and engaged until police arrive, 
(7) complete documentation. 
Participants who do not report imminent risk but indicated a > 0 score on the PHQ item 9 will be 
provided a list of resources drawn from ZSFG. This risk assessment will be supervised by a 
member of clinical staff on the research team, and appropriate referrals and resources provided 
as needed as described. This is consistent with the risk monitoring procedures we are using in our 
current clinical trial (R34 MH113616, PI: Schueller). Supporters will also be trained on a similar 
crisis management protocol, but will learn to assess for level of risk themselves so will only need 

to contact the clinical supervisor immediately in assessment of high level of risk but will also 
complete a report indicating any risk assessed that will be provided to the clinical supervisor for 
review and sign-off with 24 hours. 
12.2  
Describe any anticipated risks and discomforts not listed above: 
RISKS: 
* 
(REQUIRED)
Risks of the intervention: Digital mental health intervention programs generally have not been 
shown to cause harm. We do not expect that this intervention creates an added risk for suicidal 
ideation. 
Risks associated with research assessments: Research assessments include questions about 
depression, anxiety, and other mental and emotional problems. There is a risk that responding to 
these assessments may cause some level of distress discomfort to participants.  
Risk of delayed treatment: By participating in this study and using SilverCloud, it is possible 
some people may delay care that might otherwise be effective, resulting in additional distress or 
potential further impairment that might make later treatment more challenging. However, given 
that lack of Spanish speaking providers, this is unlikely. It is also possible that a participant might 
try a technology, not receive any benefit, and be less likely to seek subsequent care due to the 
belief that it might not be effective. Patients who are currently taking antidepressant medication 
will be eligible to participate, if they are on a stable dose for at least 6 weeks. Patients who are 
currently engaged in psychotherapy will not be eligible, however participants will be allowed to be 
referred to psychotherapy will participating which will mitigate concerns with risks of delaying 
treatment.  
Risks associated with potential loss of confidentiality/privacy: There is a slight risk of loss 
of confidentiality or privacy.  There is some possibility that others in the participants’ lives may 
see the participant’s app notifications. There is also a small possibility that databases may be 
hacked, even though they are behind secure firewalls. Confidentiality may be broken by research 
staff to ensure the participant’s safety if they identify an imminent threat to self or others. There 
is also the remote possibility that research records will be subpoenaed by a court of law. 
Randomization to an inferior outcome depending on group assignment: We can’t speak 
for sure about inferior outcomes which is why we don’t think it’s appropriate to state here. 
Risk of data charges: There could be some additional data charges as a result of the 
SilverCloud app usage by the participants' phone provider. 
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
Risks of the intervention: Upon enrollment, participants will be instructed to report any 
unanticipated consequence of using the digital intervention to study staff. We will monitor any 
unanticipated consequences on outcome assessments.
Risk of delayed treatment: We will explain to participants in the study information sheet that 
these apps are not intended to replace professional care and encourage participants to always 
speak to licensed professionals if they are experiencing distress or need professional support.
Risks associated with potential loss of confidentiality/privacy: All of potential losses of 
confidentiality will be disclosed in the consent documents. SilverCloud collects data in accordance 
with the EU General Data Protection Regulation (GDRP), the Data Protection Act 2018 and other 
applicable data protection and e-privacy law. REDCap is a secure online assessment platform, 
made available and supported through UCSF’s CTS. Data gathered by SilverCloud includes 
responses to the CBT assignments, IP address, unique identifiers, browser type and version, time 
zone and language, country, pages viewed. Although highly unlikely to occur, loss of privacy 

would reveal PHQ-9, GAD-7, interaction with the SilverCloud platform, IP addresses and browsing 
behavior. Further, peer supporters will interact with patients either through brief phone calls or 
secure messaging
To ensure that confidentiality is maintained throughout the study, only secure software and tools 
will be used for data collection. Each participant will be given a unique numeric identifier 
(different from their name or medical record number) that will be affixed to any research material 
associated with the patient. This information will be kept in a password-protected file on a UCSF 
server; only study staff will have access to this file. Only the researchers and industry partner 
support staff will have access to data stored on the respective app servers. When analyses have 
been completed and all research potential exhausted, these records will be destroyed. Any paper 
documentation (which we do not anticipate) is kept in locked file cabinets or a locked file room.
All research team members will be trained in data security and will need to sign an official 
university confidentiality document prior to being granted access to confidential files. All analyses 
reported from this study will only contain aggregate data. The data from individual participants 
may be reported, anonymously, as examples of participant feedback.    
All research team members will be trained in data security and will need to sign an official 
university confidentiality document prior to being granted access to confidential files. All analyses 
reported from this study will only contain aggregate data. The data from individual participants 
may be reported, anonymously, as examples of patient feedback. 
Data collected by the SilverCloud platform created for this project will be encrypted and stored on 
the SilverCloud online server. When the data are transmitted to our local server at UCSF, we use 
commercial-grade HTTPS encryption to secure the contents of the network transmission. 
Furthermore network payloads are further protected using public-key cryptography to encrypt the 
data so that only the intended server may decode the contents of the transmission, even in cases 
where the transport layer encryption (HTTPS) may be compromised. 
 
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
Briefly discuss the other possible benefits:
Potential benefits of the study to safety-net setting and primary care clinics include the 
improvement of best practices in digital mental health for LEP Latinx populations. This important 
step is improving care for vulnerable populations, because of the lack of mental health 
professionals to meet the burden of disorder for depression and anxiety, especially for 
underrepresented populations like Latinx. We need new interventions that can be deployed at 
scale in low-resource settings and meet the needs of individuals for diverse groups. 
Participants may benefit from the CBT intervention and will notice a reduction in depression and 
anxiety scores.
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:

                                                                        
Risks in the study are only slightly if at all greater than standard care. We have also attempted to 
address any risks with various safeguards.
                                                       
    
12.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)
 Yes  
 No
This is not required for minimal risk research but the UCSF IRB strongly recommends 
one to ensure the data collected are adequate to meet the research aims:
13.0
 
Data and Safety Monitoring Plan
13.1  
DATA AND SAFETY MONITORING PLAN (DSMP): 
* 
(REQUIRED) Provide a summary of the DSMP:
All greater than minimal risk studies are required to provide a plan. 
Lack of an adequate plan is one of the most common reasons why 
IRB approval is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key 
areas that should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, 
and safety
A description of who will perform the monitoring and at what 
frequency (e.g., the PI only, a contract research organization, a Data 
and Safety Monitoring Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse 
events, breaches of confidentiality, unanticipated problems involving 
risk to participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the 
UCSF IRB, the study sponsor, and other appropriate entities
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study 
interventions
To ensure that confidentiality is maintained throughout the study, only secure software and tools 
will be used for data collection. Each participant will be given a unique numeric identifier 
(different from their name or medical record number) that will be affixed to any research material 
associated with the patient. This information will be kept in a password-protected file on a UCSF 
server; only study staff will have access to this file. Only the researchers and industry partner 
support staff will have access to data stored on the respective app servers. When analyses have 
been completed and all research potential exhausted, these records will be destroyed. Any paper 
documentation (which we do not anticipate) is kept in locked file cabinets or a locked file room.

All research team members will be trained in data security and will need to sign an official 
university confidentiality document prior to being granted access to confidential files. All analyses 
reported from this study will only contain aggregate data. The data from individual participants 
may be reported, anonymously, as examples of participant feedback.    
All research team members will be trained in data security and will need to sign an official 
university confidentiality document prior to being granted access to confidential files. All analyses 
reported from this study will only contain aggregate data. The data from individual participants 
may be reported, anonymously, as examples of patient feedback.
Data collected by the SilverCloud platform created for this project will be encrypted and stored on 
the SilverCloud online server. When the data are transmitted to our local server at UCSF, we use 
commercial-grade HTTPS encryption to secure the contents of the network transmission. 
Furthermore network payloads are further protected using public-key cryptography to encrypt the 
data so that only the intended server may decode the contents of the transmission, even in cases 
where the transport layer encryption (HTTPS) may be compromised. 
Any reportable post-approval research-related event or information will be communicated to the 
IRB in accordance with the IRB’s 
.
post-approval reporting requirements
13.2  
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
(REQUIRED) Will a Data and Safety Monitoring 
Board (DSMB) be established:
Yes 
No 
Guidelines
A Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee 
(DMC) is a formal, independent committee that is specifically established to 
conduct interim monitoring, oversight and analysis of study information and 
data to assure the continuing safety, efficacy, appropriateness, relevance, 
and integrity of the study.
 
The UCSF IRB reserves the right to request a DSMB/DMC for any study. 
However, the following are factors that the IRB will consider when making 
this determination:
There is a significant likelihood of a serious adverse event to subjects
The study is conducted at multiple sites and the level of risk is greater 
than minimal
The study generates data that are blinded or randomized
The study involves a large number of patients randomized to one of 
two or more interventions
A study for which the performance of an interim analysis is crucial for 
the protection of the subjects
First use in humans
First use in children
The study involves gene therapy, stem cell therapy, or other novel 
interventions for which long-term outcome data are not known or 
available
14.0
 Confidentiality, Privacy, and Data Security
14.1  
Indicate how subject privacy will be protected: 
 
 PROTECTING PRIVACY: 
*
(REQUIRED)
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 

called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  
Do any of the instruments ask about illegal or stigmatized behavior: 
 SENSITIVE DATA: 
*
(REQUIRED)
  Yes  
  No
14.3  
Could a breach of 
SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
* 
privacy or confidentiality result in any significant consequences to participants, such as criminal or 
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation: 
  
(REQUIRED)
  Yes  
  No
14.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
14.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others, or HIV status and other reportable conditions: (REQUIRED)
 Yes  
 No
The confidentiality and privacy section of the consent form must 
include this as a possible risk of participation. 
 
Describe the types of reportable information the research team may 
* 
encounter and provide the details of the reporting plan: (REQUIRED)
                                                                        
If patients report that they are in danger of harming themselves or others or if they report 
instances of child or elder abuse, these things are reportable. They are informed of this at the 
beginning of the study and as a standard protocol.
                                                       
    
14.6  
Will this study obtain a Certificate of Confidentiality: 
CERTIFICATE OF CONFIDENTIALITY: 
* 
(REQUIRED)
 Yes  
 No
NOTE: if your study is federally funded and collects personally 
identifiable information, it will automatically be issued a Certificate 
of Confidentiality. You must include the required Certificate of 
Confidentiality language in the consent form. 
14.7  
Will there be any sharing of 
 research test 
 SHARING OF RESEARCH RESULTS: 
*
EXPERIMENTAL
results with subjects or their care providers: (REQUIRED)
  Yes  
  No

14.9  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED)
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at ZSFG
In addition to signing a consent form, each subject will have to sign 
the 
 
UCSF Participant Authorization for Release of PHI for Research
(HIPAA Form). Upload the HIPAA Form in the Other Study 
Documents section of the Initial Review Submission Packet Form. 
Failure to have patients sign the HIPAA Authorization is one of the 
most common findings from QIU Routine Site Visits.
Guidance about HIPAA requirements and other HIPAA-related forms
 are available online on the IRB's HIPAA page.
If derived from a medical record, identify source (UCSF Health APeX, 
SFDPH Epic, VA CPRS, etc.):
EPIC
14.10  
 
 Answer the following questions to determine if this study is subject to 
* GDPR APPLICABILITY:
additional data privacy regulations under the General Data Protection Regulation (GDPR and/or UK 
GDPR): (REQUIRED)
 Is the study targeting or recruiting 
 or 
*
European Economic Area (EEA)
United Kingdom (U.K.) participants, or collecting and using the personal 
data of participants located in the EEA or the U.K.: (REQUIRED)
NOTE: If this study is being carried out online and may recruit 
people living in the EEA zone or the U.K., you should check 'Yes.'
  Yes  
  No
* Is the study receiving data from a site that is collecting data from 
individuals located in the EEA or U.K. nations: (REQUIRED)
  Yes  
  No
14.11  
Will any of the following identifiers be collected and included in the research 
IDENTIFIERS: 
* 
records, even temporarily: (REQUIRED)
Names
Dates
Postal addresses (if only requesting/receiving zip codes check Yes to the Zip Code question 
below instead of checking this box)
Phone numbers

Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)
  Yes  
  No
14.13  
 
Will health information or other clinical data be accessed from UCSF 
* PATIENT MEDICAL RECORDS: 
Health, Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General (ZSFG): 
(REQUIRED)
 Yes  
 No
14.16  
Does the research require access to any of 
HIPAA - PERMISSION TO ACCESS SENSITIVE DATA: 
* 
the following types of health information from the medical record: (check all that apply) 
(REQUIRED)
Drug or alcohol abuse, diagnosis or treatment
HIV/AIDS testing information
Genetic testing information
Mental health diagnosis or treatment
None of the above
Important note: Ensure that participants initial the corresponding 
line(s) in Section C of the HIPAA authorization form during the 
consent process.
14.20  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical trial 
management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)

Other:
What online survey or computer assisted interview tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
* For each app and device, please provide: (REQUIRED)
the name of the mobile application or wearable device
name  of the manufacturer / application owner
the FDA status (required for mobile health applications and mobile 
health devices)
Patients will be introduced to SilverCloud, a web and mobile platform that can be accessed 
through computers and smartphones. SilverCloud delivers online CBT. Developed by SilverCloud 
Health, Owned by Amwell, SilverCloud falls under the category of apps which FDA has exercised 
enforcement discretion over so the FDA status is not applicable
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
San Francisco VA Health Care System (SFVAHCS)
Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
Provide more details about where study data will be stored: 
* 
(REQUIRED)
Data will only be stored on UCSF Box. Participants data will be stored on SilverCloud servers. 
 
14.21  
 Will patient records reviewed under this approval be 
* ADDITION OF RECORDS TO A REGISTRY:
added to a research database, repository, or registry (either already existing or established under 
this protocol): (REQUIRED)
  Yes  
  No
14.22  
During the lifecycle of data collection, transmission, and storage, will identifiable 
DATA SHARING: 
* 
 
information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)
 Yes  
 No
* Who will have access to the data: (REQUIRED)
Collaborators listed in the study application

NIH or other shared data repository
Sponsors
FDA
Other 3rd party (such as vendors/contractors)
IMPORTANT: The IRB now recommends that all consent forms 
include a provision for sharing of de-identified/coded data to permit 
re-use of data for secondary research purposes. This doesn't apply 
if you've been granted a waiver of consent for this study.
Provide the details of whom the data will be shared with and what types 
* 
of information and identifiers will be shared: (REQUIRED)
Users will have to make a login so SilverCloud will have their email addresses, we'll also share 
identified data between the UCSF and UCI teams
14.23  
 
: How will data be securely shared with the 3rd party: 
* DATA SHARING METHODS
(REQUIRED)
Collaborators will access data in MyResearch
Collaborators will access data in REDCap
Collaborators will be sponsored as an affiliate and be treated as an UCSF user (includes using 
UCSF Box)
UCSF Secure Email will be used to share data
Collaborator’s or Sponsor’s system will be used (specify below)
Other method (describe below)
Please provide details about how the data will be shared:
Secured box folders will be shared with collaborators.
Data will also be securely shared via the SilverCloud platform.
15.0
 Financial Considerations
15.1  
Will subjects be paid for participation or receive any other kind of compensation: 
* PAYMENT: 
(REQUIRED)
 Yes  
 No
15.2  
 
Will participants be reimbursed for expenses related to study participation: 
* REIMBURSEMENT: 
(REQUIRED)
  Yes  
  No
15.3  
Participant payment or compensation methods (check all 
* PAYMENT/REIMBURSEMENT METHODS: 
 
that apply): (REQUIRED)
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card
UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:

15.4  
Describe the schedule and amounts of payments, including the total subjects 
* PAYMENT SCHEDULE: 
can receive for completing the study: (REQUIRED)
If there are multiple visits over time, explain how payments will be prorated for partial 
completion
If deviating from recommendations in Subject Payment Guidelines, include specific 
justification below
Patients will be recruited by direct contact from our research team or referrals from providers. All 
participants will receive $25 for participation in interviews regardless if they completed 
participation in the intervention in the form of either gift card (Amazon) or cash.
                                                       
    
15.5  
Will subjects or their insurance be charged for any study activities: 
 COSTS TO SUBJECTS: 
*
(REQUIRED)
  Yes  
  No
16.0
 Other Approvals and Registrations
16.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
17.0
 Qualifications of Key Study Personnel and Affiliated 
Personnel
 
NEW: January 2019 - Affiliated personnel who do not 
need access to iRIS no longer need to get a UCSF ID. 
Instead, add them below in the Affiliated Personnel 
table below. 
17.1  
 
Qualifications of Key Study Personnel:
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in 
 select the KSP 
Section 3.0,
from the drop down list and add a description of their study responsibilities, 
qualifications and training. In study responsibilities, identify every individual 
who will be involved in the consent process. Under qualifications, please 
include:

Academic Title
Institutional Affiliation (UCSF, ZSFG, SFVAHCS, etc.)
Department
Certifications
NOTE: This information is required and your application will be 
 
considered incomplete without it. If this study involves invasive or 
risky procedures, or procedures requiring special training or 
certification, please identify who will be conducting these 
procedures and provide details about their qualifications and 
training. Click the orange question mark for more information and 
examples. 
 
Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects 
Protection Training through 
 prior to approval of a new study, or a 
CITI
modification in which KSP are being added. More information on the CITI 
training requirement can be found on our 
. 
website  
 
* Definition of Key Study Personnel and CITI Training Requirements (Nov, 
 UCSF Key Study Personnel include the Principal Investigator, other investigators 
2015):
and research personnel who are directly involved in conducting research with study 
participants or who are directly involved in using study participants’ identifiable private 
information during the course of the research. Key Personnel also include faculty mentors
/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical 
Fellows serving as PI on the IRB application.
 
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
Aguilera, Adrian, PhD
Site clinical trial lead
/Peer training/Cultural 
adaptations
UC Berkeley Assistant 
Professor and UCSF 
clinical researcher with 
extensive research 
experience as well as 
clinical experience 
working with low-income 
and Spanish speaking 
populations.
Dr. Lyles, Courtney R PhD, 
PhD
Mixed methods and 
qualitative analyses
UCSF clinical researcher 
with extensive research 
experience as well as 
clinical experience 
working with low- income 
and Spanish speaking 
populations.
Schueller, Stephen M
Lead SilverCloud 
deployment, 
implementation 
UC Irvine Associate 
professor with extensive 
research experience with 

evaluation
diverse populations.
Dr. Fortuna, Lisa R MD, 
MPH
Coordinate peer 
supporters/facilitate 
inreach
Chief of Psychiatry and 
Vice-Chair at Zuckerberg 
San Francisco General 
Hospital/UCSF.
Dr. Ochoa-Frongia, Lisa M 
MD
Recruit/Outreach via 
patient registry
Associate Professor of 
Medicine at UCSF, in the 
Division of General 
Internal Medicine at San 
Francisco General 
Hospital (SFGH). 
Practicing primary care 
physician and Associate 
Medical Director at 
Richard Fine People's 
Clinic.
Rosales, Karina
Assisting with day to day 
study operations 
including data collection, 
participant enrollment, 
follow up and obtaining 
informed consent.
UC Berkeley Research 
Assistant, UCSF affiliate, 
assisting Dr. Aguilera 
with day to day study 
operations including data 
collection, participant 
enrollment and follow up.
17.2  Affiliated Personnel:
Instructions:
 
This section is for personnel who are not listed in Section 3.0: Grant Key 
 because their names were not found in 
Personnel Access to the Study
the User Directory when 
 the iRIS Database and MyAccess directories 
both
were searched. Add any study personnel who fit 
 of the following criteria 
ALL
in the table below:
They meet the definition of Key Study Personnel (see above), and
They are associated with a UCSF-affiliated institution (e.g., SFVAHCS, 
Gladstone, Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do 
 have a UCSF ID, 
not
and
They do 
 need access to the study application and other study 
not
materials in iRIS.
 in the 
Note: Attach a CITI Certificate for all persons listed below
Other 
 section of the 
Study Documents
Initial Review Submission Packet 
 after completing the 
.
Form
Study Application
 
Click the orange question mark icon to the right for more information on 
who to include and who not to include in this section.
 
Do 
 list personnel from outside sites/non-UCSF-affiliated institutions. 
not
Contacts for those sites (i.e. other institution, community-based site, 
foreign country, or Sovereign Native American nation) should be listed in 
the 
 section of the application.
Outside Sites
 

If there are no personnel on your study that meet the above 
criteria, leave this section blank.
 
Name
Institution
Telephone
E-mail
Role
No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated 
person listed above:
18.0
 End of Study Application
End of Study Application Form
 
:
To continue working on the Study Application
Click on the section you need to edit in the left-hand menu. Remember to save through 
the entire Study Application after making changes.
 
:
If you are done working on the Study Application
Before proceeding, please go back to Section 4.0 Initial Screening 
Important: 
Questions and 
 through the form to make sure all the relevant 
Save and Continue
sections and questions have been included. If you've changed any answers since you 
started, the branching may have changed. Your application will be incomplete and it will 
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
. If this is a new 
Save and Continue
study, you will automatically enter the 
, 
Initial Review Submission Packet Form
where you can attach 
or other 
. Review the 
consent forms 
study documents
Initial 
 for a list of required attachments.
Review Submission Checklist
 
Answer all questions and attach all required documents to speed up your 
approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to 
answer a 
 about the application form.
survey

Statistical Design and Power 
 
Preliminary Data Analysis 
 
At the beginning of the project, Dr. Hoang will work with the research team, including the 
postdoctoral fellow overseeing quantitative data collection, to create data reporting tables. 
These data reporting tables will allow ongoing monitoring of demographic variables, to facilitate 
reporting to the DSM, and to support statistical analysis when data collection is completed. An 
example of a shell table is provided below.  
 
We will screen the collected data using graphs and descriptive statistics to ensure data are 
within expected ranges, to check for outliers and abnormal values, and to ascertain variable 
distributions meet the assumptions of the statistical tests to be used. Using t-tests and chi-
squared, we will test that random assignment was not compromised and that participants 
assigned to conditions are equivalent on important baseline demographics and outcome 
variables including age, gender, acculturation, technology literacy, and baseline depression 
(PHQ-9 and GAD-7). If any effects are found, we will adjust for them using the confounding 
variable as a covariate in model testing or as a stratification variable and will take the use of 
these statistical techniques into account in interpretation of the outcome. We will test to 
determine if there is differential attrition between conditions and will use the appropriate missing 
data strategies described in more detail below. 
 
In all analyses using continuous predictors we will assess the linearity assumption by fitting 
higher-order polynomial terms and, for continuous outcomes, plotting residuals versus 
predictors. If the continuous predictor cannot be accommodated in simple form (e.g., linear and 
quadratic), it will be treated as categorical.  
 
Summary of demographic and clinical characteristics of the study patients 
Characteristics 
 
Peer-supported 
(N=) 
Unsupported 
(N=) 
P-value 
Demographics 
Age (mean, SD) 
 
 
 
Gender (%) 
   Male 
   Female 
 
 
 
Education 
 
 
 
Acculturation 
 
 
 
Technological literacy 
 
 
 
Previous use of mental health services 
 
 
 
Baseline clinical characteristics 
Depression  
  PHQ-9 score (mean, SD) 
 
 
 
Anxiety  
   GAD-7 score (mean, SD) 
 
 
 
Comorbidities 
 
 
 
Current use of antidepression 
medication 
 
 
 
 
 
 
Contact PD/PI: Schueller, Stephen Matthew 
Statistical Design and Power
Page 144

Missing Data within Questionnaires  
 
All self-report questionnaires will be administrated in Spanish via a secure web assessment 
platform (REDCap), which can immediately identify questions that have not been answered and 
prompt the participant to either answer the question or indicate that it was intentionally left 
blank. If missing data are identified, the study team will be alerted and will attempt to obtain the 
missing data from the participant. This includes providing a follow-up reminder via email and a 
follow-up phone call to determine if participants would rather answer assessments questions 
over the phone. These procedures minimize missing items and data. If a measure of scale is 
missing less than 20% of the data points that are needed to construct a scale, multiple 
imputation107 will be used to infer the values based on the other elements of the scale that are 
not missing. If a scale or subscale is missing 20% or more of the data, that scale of subscale will 
be determined to be missing.  
 
Missing Data Points  
 
We note that based upon our previous work, we expect to obtain complete follow-up data on the 
majority of patients, including those discontinuing treatment.72,73 Participants who drop out of 
treatment will be retained and we will continue to contact for assessment data, unless they 
withdraw consent. Completion of surveys will be promoted through the use of monetary 
incentives and consistent monitoring of study data. Participants who do not complete online 
assessments within a one-week window will be contacted by our research staff and provided the 
option to complete follow-up measures over the telephone. We do not expect the loss-to-follow 
up rates to differ across treatment arms. However, to be safe, in our analyses of longitudinal 
data we will build a logistic regression model for missing data, with the outcome being 
conditional missing data at a particular time point (conditional on participation up to that point) 
and will include possible predictors of missing data (i.e., gender, age, socio-economic factors, 
primary care clinic, etc). Loss-to-follow up rates at any point can then be calculated as the 
product of the conditional probabilities.108 We will also conduct sensitivity analyses that consider 
any patients with missing data points as a separate group and see if missing data change the 
results (e.g., we will compare models of three groups of gender: male, female, and missing 
data). 
 
Aim 1:  
 
Quantitative:  
 
Effectiveness: The primary outcome is the change in PHQ-9 and GAD-7 scores from baseline to 
8-weeks (which this study is powered on). We will compare PHQ-9 and GAD-7 scores between 
the conditions using mixed-effect models adjusting for the intra-clinic correlation. Mixed-effect 
models generally require three time points, which is why we include a post-treatment 
assessment at 3-months. Although every effort will be made to avoid missing data (e.g., as 
described above e-mail/text/phone reminders for assessments, financial incentives 
for completing assessments), mixed-effect models are robust to missing data as they do 
not require complete case data (i.e., at every time point); thus, even participants with missing 
data at some assessments are included in the analysis and results are modeled on the basis of 
the available data. In the case of missing data, we will also analyze if missing data is related to 
any observable characteristics. Secondary clinical outcomes for this trial will consist of the 
PROMIS Social Health and clinical outcome data collected from the SilverCloud platform.  
 
Contact PD/PI: Schueller, Stephen Matthew 
Statistical Design and Power
Page 145

The mixed-effects models will analyze change in outcome variables and determine whether this 
change differs by condition (peer-supported vs. unsupported). Because randomization for the 
intervention will occur at the patient-level models will have patients nested by provider nested by 
clinic.  
 
Use of Platform: A secondary outcome measure will be engagement with the SilverCloud 
platform as defined by total time on platform. “Total time” on platform was chosen as the 
outcome measure rather than logins or other measures of frequency of engagement because 
differences in the length of each login may represent important differences in participant 
engagement. Additionally, we will collect additional measures of use including (participants use 
each feature, number of peer coach interactions, and number of weeks that participants meet 
the expected use criteria of 3 logins per week).  
 
All analyses will be conducted based on intention-to-treat principles. Additionally, we will include 
participant characteristics including sex, age, education, type of Latinx subgroup, acculturation, 
technology literacy, and previous use of mental health services as covariates. We will also 
explore baseline severity of symptoms of depression and anxiety as well as peer-supporter 
(e.g., to determine if certain peer supporters resulted in superior outcomes) as potential 
moderators of treatment response. The mixed-effect models will analyze whether patient 
outcomes across condition vary while including peer supporter along with other moderating 
factors.  
 
Mediational analysis: We will also explore whether use of the platform mediates changes in 
clinical symptoms. Mediation will be examined using a bootstrapping procedure. This procedure 
produces bias-corrected and accelerated bootstrapped confidence intervals of the product of the 
direct pathways between condition and the mediator (a), the mediator and the outcome (b), and 
an estimate of the indirect effect (ab). To reduce potential bias resulting from multiple tests, 
mediation of use will be examined first using a composite of overall use of the intervention 
platform. A significant mediator of benefit, we will then proceed to examine frequency of 
different types of activities (e.g., time spent on platform, posting of content, reading of content, 
messages sent). We will compute different models for activity from users of the platform as well 
as by supporters of the platform. 
 
Power analysis:  The sample size was determined based on comparisons between intervention 
conditions (peer-supported vs. unsupported) regarding effectiveness. We used meta-analytic 
estimates of changes in depression and anxiety scores in digital interventions including both 
supported and unsupported dCBT. Conservatively, we estimated the sample size needed to 
detect a two-point difference in change on the PHQ-9 or GAD-7 between the peer-supported 
and unsupported arms. At an α = .05 we would need 300 participants (150 per condition) to 
achieve power of 90%. Based on meta-analytic data, we estimate that attrition rates will be 25% 
in the supported arm and 29% in the peer-supported arm. Therefore, we increased our 
proposed sample size to adjust for estimated attrition resulting in estimates of 390 
patient participants needed (195 per arm to maintain equivalent arms at baseline) to 
achieve excellent power on Aim 1. We indicate an example of this estimation using the PHQ-
9 in the table below using the baseline values from the PHQ-9 value from our patient registry at 
ZSFG.  
 
PHQ-9 
Baseline 
End 
Pre-post 
N 
N + % attrition 
Supported 
15.1  
8.1  
-7.0  
150 
190 (25% attrition) 
Unsupported 
15.1 
10.1 
-5.0 
150 
195 (29% attrition) 
 
Contact PD/PI: Schueller, Stephen Matthew 
Statistical Design and Power
Page 146

 
Aim 2:  
 
Quantitative: Guided by the RE-AIM framework, we will measure the impact on the primary care 
clinics including reach, adoption, and implementation. The primary outcome will be adoption. 
Adoption will be defined as the percent of providers with at least one enrolled patient with 
comparisons made across block of providers within each primary care clinics. We will also 
compare characteristics of providers with at least one enrolled patient on available data such as 
degree, specialty, and years practice. Reach will be defined as (a) the number of patients 
contacted via phone or brochure/text across the inreach and outreach arms and (b) the number 
of patients who create a login for SilverCloud, over the number of people determined to be 
eligible. Patient costs will include any time associated with engagement in treatment, including 
time spent on calls, messages, or on the dCBT site. Patient time in treatment will be captured 
through passive data collection estimating time on site and time of any phone calls that will be 
audiotaped. Self-reported salary will be used to estimate patient time cost. Peers will track time 
allocated to all support activities, including scheduling, messages, etc. Any scheduled phone 
sessions missed without 24-hour notice will be counted as having occurred as this is a cost 
incurred. dCBT costs will also include technical costs, including website maintenance and 
technical support. These costs will be calculated based on hourly rates for peers and payment 
made to SilverCloud for technical costs.  
 
We will compare the proportion of patients referred, initiating, and completing treatment within 
each of the clinic blocks assigned to each implementation strategy using mixed-effects models 
using these outcomes represented as proportions as continuous outcome variables. These 
models will allow us to control for intraclinic clustering of providers as well as patient 
characteristics at each clinic (e.g., number of patients, percentage of Latinx patients). The two 
primary care clinics at ZSFG, consist of 166 FTE providers, 78 providers in the RFPC and 88 
providers in the FHC. For randomization purposes we will create four blocks of providers (2 per 
clinic) consisting of approximately 40 providers each. Model comparisons will then compare 
blocks assigned to inreach vs. blocks assigned to outreach.   
 
Aim 3: We will conduct a mixed-methods evaluation consisting of surveys, interviews, and focus 
groups. 
 
Quantitative: For survey questions, we will use one-way ANOVAs to compare relative 
acceptability, appropriateness, and feasibility among the 2 treatment conditions. Any items that 
produce averages below the scale midpoint (3 = neither agree not disagree) will be addressed 
through analysis of the focus group and interview data to explore if we can determine aspects of 
the intervention or the patient or supporter experience that would correspond to those 
unfavorable ratings. We will compare peer-supported and unsupported using t-tests at each 
time point. We will also complete mediational analyses to determine if relational or technique 
factors mediate changes in depression. 
 
Qualitative: We will conduct semi-structured interviews to ask patients and peers to assess 
attitudes towards the intervention, support component, cultural relevance and CBT mechanisms 
of use of cognitive and behavioral skills. We will also interview clinic leadership and providers to 
assess climate, clinic readiness, and attitudes towards the intervention. 
 
For qualitative analysis we will use thematic analysis as described by Braun and Clarke.98,99,103 
This six-step analytical approach facilitates the process of becoming familiar with the data, 
systematically identifying individual codes, grouping those codes into preliminary themes, 
Contact PD/PI: Schueller, Stephen Matthew 
Statistical Design and Power
Page 147

defining and naming the final themes that commonly occurred across the entire data set, and 
then selecting examples from the data to accurately illustrate each theme. In thematic analysis, 
current theories or prior research can be used as initial categories as starting points for the data 
analysis. We will use Grol and Wensing’s104 multilevel model of barriers and facilitators as initial 
themes. These themes will include specific barriers and facilitators at the level of innovation, 
individual professional, patient, social context, organizational, and economic and political 
context. We will use a qualitative software analysis tool such as ATLAS.ti105 to code the data. 
We will use guidelines for establishing reliability and validity in qualitative research which focus 
on ensuring the coherence, distinctness, and credibility of themes and subthemes.106 We will 
use consensus to ensure that the analytic narrative represents the data, in relation to the 
research questions. In our consensus process, all reviewers will independently code all of the 
transcripts and meet to compare their coding to arrive at consensus judgments through open 
dialogue.109-111 Consensus coding is designed to capture data complexity, avoid errors, reduce 
groupthink, and circumvent some research biases. 
 
Contact PD/PI: Schueller, Stephen Matthew 
Statistical Design and Power
Page 148