Implementing mHealth for Schizophrenia in Community Mental Health Settings
Phase: NA
Conditions: Schizophrenia
Sponsor: University of Washington

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
Implemented 02/29/2024  Version 3.1 - Page 1 of 2
IRB CONTINUING REVIEW APPROVAL 
October 7, 2024
Dear Dror  Ben-Zeev:
On 10/7/2024, University of Washington IRB Committee J reviewed the following application:
Type of Review:
Continuing Review
Title of Study:
Implementing mHealth for Schizophrenia in Community 
Mental Health Settings
Investigator:
Dror  Ben-Zeev
STUDY ID
STUDY00006141
CR ID:
CR00008895
Funding:
Name: National Institute of Mental Health (NIMH), Grant 
Office ID: A132489, Funding Source ID: R01MH116057-
01A1 
IND, IDE, or HDE:
None
Relying Sites:
IRB Approval
Under FWA #00006878, the IRB renewed approval for your activity from 10/7/2024 to 10/6/2025. 

Your application qualified for expedited review (minimal risk; Category 5 and 7).

Tracking IRB approval periods and preventing a lapse is the researchers responsibility. 
However, the Zipline system sends automated courtesy reminders prior to expiration of 
approval. If a renewal application or study closure is not received within 90 days of 
expiration, HSD may administratively close the study. In some circumstances, HSD may 
refuse to review additional submissions from the researcher until a status report is 
received, lapsed IRB approval may be considered continuing non-compliance, and the study 
may be terminated by the IRB.

Your study has a federal Certificate of Confidentiality (CoC). See this INFORMATION SHEET 
for a description of the CoC protections and responsibilities.

If you plan to continue data collection past the expiration of the CoC, contact the Human 
Subjects Division prior to expiration. We will help you determine whether you need to 
apply for a CoC extension. 
Thank you for your commitment to ethical and responsible research. We wish you great success!
Sincerely,
Kelly McPherson
IRB Administrator, Team J
206-221-6422
Kellymc3@uw.edu 

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
Implemented 02/29/2024  Version 3.0- Page 2 of 2

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
ZIPLINE APPLICATION: IRB Protocol 
 
 
 
INSTRUCTIONS 
• If you are requesting a determination about whether your activity is human subjects research or 
qualifies for exempt status, you may skip all questions except those marked with a          . For example 
1.1  must be answered. 
• Answer all questions. If a question is not applicable to your research or if you believe you have already 
answered a question elsewhere in the application, state <NA= (and if applicable, refer to the question 
where you provided the information). If you do not answer a question, the IRB does not know whether 
the question was overlooked or whether it is not applicable. This may result in unnecessary <back and 
forth= for clarification. Use non-technical language as much as possible.  
• To check a box, place an <X= in the box. To fill in a text box, make sure your cursor is within the gray text 
box bar before typing or pasting text. 
• The word <you= refers to the researcher and all members of the research team, unless otherwise 
specified.  
• For collaborative research, describe only the information that is relevant to you unless you are 
requesting that the UW IRB provide the review and oversight for your collaborators as well.  
• You may reference other documents (such as a grant application) if they provide the requested 
information in non-technical language. Be sure to provide the document name, page(s), and specific 
sections, and upload it to Zipline. Also, describe any changes that may have occurred since the 
document was written (for example, changes that you9ve made during or after the grant review 
process). In some cases, you may need to provide additional details in the answer space as well as 
referencing a document.  
• If you are using this form on paper, attach the PAPER SUPPLEMENT: IRB Protocol on Paper 
 
 
INDEX 
1 Overview 
6 Children (Minors) and Parental 
Permission 
10 Risk / Benefit Assessment 
2 Participants 
7 Assent of Children (Minors) 
11 Economic Burden to 
Participants 
3 International Research Setting 
8 Consent of Adults 
12 Resources 
4 Recruiting and Screening 
Participants 
9 Privacy and Confidentiality 
13 Other Approvals, Permissions, 
and Regulatory Issues 
5 Procedures 
 
 
 
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
1 OVERVIEW 
Study Title: 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 
1.1 Home institution. Identify the home institution of the lead researcher as listed on the IRB application. 
Provide any helpful explanatory information.   
In general, the home institution is the institution (1) that provides the researcher9s paycheck and that 
considers him/her to be a paid employee, or (2) at which the researcher is a matriculated student. 
Scholars, faculty, fellows, and students who are visiting the UW and who are the lead researcher: 
identify your home institution and describe the purpose and duration of your UW visit, as well as the UW 
department/center with which you are affiliated while at the UW. 
 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria 
described in the POLICY: Use of the UW IRB. 
 
The University of Washington 
1.2 Consultation history. Have you consulted with anyone at HSD about this study? 
It is not necessary to obtain advance consultation. If you have: answering this question will help ensure 
that the IRB is aware of and considers the advice and guidance you were provided.   
 
 No 
 
 
x Yes 
→ If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by 
email, phone call, in-person meeting). 
 
 
 
 
I have consulted with Amanda Guyton on Nov 5th and 8th, 2018.  
1.3 Similar and/or related studies. Are there any related IRB applications that provide context for the 
proposed activities? 
Examples of studies for which there is likely to be a related IRB application: Using samples or data 
collected by another study; recruiting subjects from a registry established by a colleague9s research 
activity; conducting Phase 2 of a multi-part project, or conducting a continuation of another study; 
serving as the data coordinating center for a multi-site study that includes a UW site. 
 
Providing this information (if relevant) may significantly improve the efficiency and consistency of the 
IRB9s review. 
 
x No 
 
 
 
Yes 
→ If yes, briefly describe the other studies or applications and how they relate to the 
proposed activities. If the other applications were reviewed by the UW IRB, please also 
provide: the UW IRB number, the study title, and the lead researcher9s name. 
 
 
 
      

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency 
that affect your proposed activity? 
HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To 
ensure fairness, it is HSD policy to review applications in the order in which they are received. However, 
HSD will assign a higher priority to research with externally-imposed urgency that is beyond the control 
of the researcher. Researchers are encouraged to communicate as soon as possible with their HSD staff 
contact person when there is an urgent situation (in other words, before submitting the IRB application). 
Examples: a researcher plans to test an experimental vaccine that has just been developed for a newly 
emerging epidemic; a researcher has an unexpected opportunity to collect data from students when the 
end of the school year is only four weeks away.  
 
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be 
requested to compensate for a researcher9s failure to prepare an IRB application in a timely manner. 
Note that IRB review requires a certain minimum amount of time; without sufficient time, the IRB may 
not be able to review and approve an application by a deadline.  
 
 
No 
 
 
x Ye
s 
→ If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
IRB approval is required for this study prior to the National Institutes of Health issuing the 
notice of award (NOA). IRB review is requested as soon as possible to avoid delays in 
funding. 
 
Regarding our modification submission on 2.10.20: We plan to start enrolling participants 
in early March. If this could be a prioritized review we would be very grateful. Thank you! 
 
1.5 Objectives Using lay language, describe the purpose, specific aims, or objectives that will be met by this 
specific project. If hypotheses are being tested, describe them.   
 
If your application involves the use of a HUD <humanitarian= device: describe whether the use is for <on-
label= clinical patient care, <off-label= clinical patient care, and/or research (collecting safety and/or 
effectiveness data). 
 
The proposed study: We propose to conduct a multi-site site hybrid type III 
effectiveness/implementation study in Washington State. The study involves a systematic head-to-head 
comparison between EF and IF implementation models applied to the FOCUS mHealth intervention.  
Specifically, we aim to: 
 
Aim 1. Evaluate and compare implementation outcomes. We will measure and compare FOCUS 
penetration among providers, acceptability within agencies, cost and cost effectiveness associated with 
FOCUS within CMHCs using EF or IF implementation approaches. 
Aim 2. Examine moderators and mediators of implementation effects. We will examine the extent to 
which CMHC characteristics (i.e., readiness for change, organizational culture, urban vs. rural setting) 
moderate implementation outcomes. Consistent with the NIMH experimental therapeutics approach, 
we will evaluate mechanisms of action and examine whether absorptive capacity (practitioner–level 
target) mediates the effect of EF and IF on implementation outcomes. 
Aim 3. Evaluate and compare patient outcomes. We will measure and compare whether the 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
implementation strategies differentially affect FOCUS patients9 psychiatric symptom severity, recovery, 
and illness management capacity. We will also examine whether mHealth engagement (patient-level 
target) mediates the effects of EF and IF on patient outcomes. 
 
1.6 Study design. Provide a one-sentence description of the general study design and/or type of 
methodology.   
Your answer will help HSD in assigning applications to reviewers and in managing workload. Examples: a 
longitudinal observational study; a double-blind, placebo-controlled randomized study; ethnographic 
interviews; web scraping from a convenience sample of blogs; medical record review; coordinating 
center for a multi-site study. 
 
multi-site site hybrid type III effectiveness/implementation study 
1.7 Intent. Check all the descriptors that apply to your activity. You must place an <X= in at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each 
option carefully. 
 
Descriptor 
 
 
1. Class project or other activity whose purpose is to provide an educational experience for the 
researcher (for example, to learn about the process or methods of doing research). 
 
 
 
 
 
 
2. Part of an institution, organization, or program9s own internal operational monitoring. 
 
 
 
 
 
 
3. Improve the quality of service provided by a specific institution, organization, or program. 
 
 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, 
and produce results that: 
• Are expected to be applicable to a larger population beyond the site of data collection or 
the specific subjects studied, or 
• Are intended to be used to develop, test, or support theories, principles, and statements of 
relationships, or to inform policy beyond the study. 
 
x 
 
 
 
 
5. Develop information about a drug or device through its prospective use and assignment to 
subjects, which will then be submitted to the Food and Drug Administration (FDA) in support of a 
marketing or research application for an investigational drug or device, or for changes to the 
purpose, population, or dose for an already-approved drug or device. 
 
 
 
 
 
 
6. Focus directly on the specific individuals about whom the information or biospecimens are 
collected through oral history, journalism, biography, or historical scholarship activities, to 
provide an accurate and evidence-based portrayal of the individuals. 
 
 
 
 
 
 
7. A quality improvement or program improvement activity conducted to improve the 
implementation (delivery or quality) of an accepted practice, or to collect data about the 
implementation of the practice for clinical, practical, or administrative purposes. This does not 
include the evaluation of the efficacy of different accepted practices, or a comparison of their 
efficacy. 
 
x 
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
8. Public health surveillance activities conducted, requested, or authorized by a public health 
authority for the sole purpose of identifying or investigating potential public health signals or 
timely awareness and priority setting during a situation that threatens public health. 
 
 
 
 
 
 
9. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, 
or reliability/validation testing of a questionnaire) 
 
 
 
 
 
 
10. Expanded access use of a drug or device not yet approved for this purpose 
 
 
 
 
 
 
11. Use of a Humanitarian Use Device 
 
 
 
 
 
 
12. Other. Explain: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if your proposed activity has 
one or more of the following characteristics. The purpose of this question is to provide the IRB with 
information that is relevant to its risk/benefit analysis. 
• Involves more than minimal risk (physical or non-physical) 
• Is a clinical trial, or 
• Involves having the subjects use a drug, biological, botanical, nutritional supplement, or 
medical device. 
<Minimal risk= means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests. 
 
a. Background. Provide the rationale and the scientific or scholarly background for your proposed 
activity, based on existing literature (or clinical knowledge). Describe the gaps in current knowledge 
that your project is intended to address. 
 
Do not provide scholarly citations. Limit your answer to less than one page, or refer to an attached 
document with background information that is no more than three pages long. 
 
Poorly managed, schizophrenia-spectrum disorders (SSD) are a major public health concern. SSD 
develop in approximately 1.5% of the world9s population and are ranked as one of the leading 
causes of disability and government expenditure on healthcare. 1 In the U.S. direct treatment costs 
associated with SSD are estimated at approximately $25 billion annually. 2 Poor management of 
SSD leads to symptom exacerbation and functional deterioration which often result in devastating 
outcomes including psychiatric hospitalizations, profound social isolation, unemployment, 
homelessness, victimization, self-injury, and suicide. 3-5 There are several evidence-based illness 
management interventions that have been shown to prolong the recovery periods and improve the 
outcomes of people with SSD. 6-8 Unfortunately, because they are time intensive and require the 
skills of trained providers who are often in short-supply, these interventions are seldom available at 
community mental health clinics (CMHCs) where many individuals with SSD receive care. 9-11 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
Widely available technologies can help overcome the capacity constraints of brick-and mortar 
CMHCs, expand the reach of evidence-based mental healthcare, and provide much needed illness 
management skills and resources for people with SSD, wherever they may be. 12-14 People with 
SSD use smartphones and are interested in mHealth. Access and use of mobile technology is one of 
the few areas where gaps between people with SSD and the general population are narrow. In part 
due to the Federal Lifeline Assistance Program and the perpetually dropping costs of mobile phones 
and data plans, people with SSD in the U.S. now have broad access to mobile devices. 15 A recent 
meta-analysis found mobile phone penetration rates of 82% among people with SSD over the last 
three years with over a third owning smartphones.16 Survey research shows that the majority of 
people with SSD are open to receiving services and illness management support via their personal 
mobile devices and to sharing the information captured by technologies with their providers to 
support their care. 17-19 Evidence-based mobile health (mHealth) for SSD. mHealth interventions 
have emerged in all areas of healthcare including treatment and rehabilitation of people with 
severe psychiatric conditions. 20-22 Recent studies have demonstrated that a range of mHealth 
approaches, including clinical texting support, 23-25 behavioral sensing, 26, 27 and illness self-
management apps, 28-30 are feasible, acceptable, and clinically promising for people with SSD. 
With funding from the NIMH, PCORI, and CMMI, our group developed and tested FOCUS--a multi-
modal smartphone illness self-management system for people with SSD. A series of studies 
conducted with over 500 participants across ten US states has shown that FOCUS is feasible, usable, 
highly engaging, and effective among people with SSD 28, 31-37 (see Pilot Work for more details). 
Independent reviews of mHealth in Psychiatry have identified FOCUS to be one of the most carefully 
designed, optimized, comprehensive, and patient-centered mobile interventions for a defined 
clinical population. 37 FOCUS is ready for deployment in community mental health centers, 
however, optimal methods for providing mHealth treatment of SSD in real world practice settings 
are largely unexplored. Merely making digital health tools accessible (i.e., passive diffusion) will 
produce limited uptake and reach.Using targeted implementation strategies to engage CMHC 
providers will be crucial to integration of FOCUS in standard practice.38,39 Practice facilitation is an 
evidence-based implementation strategy, but one that has not yet been applied systematically to 
mHealth in CMHC settings. Practice Facilitation refers to the use of an individual (internal or 
external to a clinical setting) who carries out a specific role aimed at helping integrate evidence 
based interventions into practice. Practice facilitators work with providers and clinical organizations 
to make changes designed to improve patient outcomes. 40-42 A meta-analysis of 23 studies 
provides strong support for practice facilitation in primary care settings. 43 The Agency for 
Healthcare Research and Quality (AHRQ) has endorsed practice facilitation as an evidence-based 
approach. AHRQ notes that practice facilitators serve as key assets for innovation implementation in 
<Safety Net Practices= providing services to patients with chronic illness (defined by the Institute of 
Medicine as clinics that deliver healthcare and other services to uninsured, Medicaid and other 
vulnerable patients). 44 Safety Net Practices and CMHCs have multiple commonalities. We adapted 
core practice facilitation functions outlined in AHRQ9s comprehensive practice facilitation 
curriculum 45 to develop two mHealth implementation models for CMHCs: External Facilitation (EF) 
(i.e., led by specialists who are not members of CMHC treatment teams), and Internal Facilitation 
(IF) (i.e., led by CMHC-embedded facilitators). Early versions of these models for implementation of 
FOCUS were shown to be feasible and acceptable to patients (see pilot work). The real-world 
implementation viability of these strategies to change the behavior of providers who work in 
CMHCs has not been evaluated. On the one hand, a few highly-trained and well-supervised external 
facilitators may be sufficient to engage many sites, creating opportunities for lowcost 
implementation on a large scale (e.g., hub-and-spoke model). On the other hand, there may be 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
return on investment considerations that would make the addition of an internal facilitator more 
appealing and contextually appropriate. There may be benefits in using recognized members of the 
clinical setting who can capitalize on existing relationships and awareness of workflows and practice 
processes, have legitimacy and trust, have access to patient records, engage in clinical team 
meetings, and conduct facilitation activities with CMHC staff in person, thus enhancing penetration. 
We propose to use IF and EF to engage providers and compare the effects of both models on 
patient and implementation outcomes. Key implementation variables. A host of implementation 
research outcomes have been articulated for studies focused on improving the quality of health 
services. 46 The promise of mHealth rests largely in its ability to efficiently transform contemporary 
healthcare at a large scale. 47, 48 Therefore, examining the impact of the implementation strategy 
on penetration of a practice within a service setting, acceptability (perception that an innovation is 
agreeable, palatable, or satisfactory), cost-effectiveness (value for money of alternative approaches) 
and affordability (i.e., the expense of the particular intervention) are particularly critical. 
Organizational factors are critical to effective implementation: With growing recognition that <bad 
systems trump good programs,= 49 the role of organizational influences on implementation has 
become widely recognized. 50-52 Critical factors influencing implementation success include the 
extent to which an organization is ready to engage in a change effort. 53 Organizational readiness 
for change varies depending on how much members of an organization determine task demands, 
resource availability, and situational factors to be favorable. A strong organizational culture (i.e., 
shared assumptions, values, and beliefs that govern how people behave in an organization) has 
repeatedly been found to predict positive implementation and service quality outcomes.52, 54, 55 
We will directly examine whether our implementation strategies have a differential impact on 
implementation outcomes depending on an organization9s culture and readiness for change. 
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that 
you or your team have that supports the feasibility and/or safety of this study.   
 
It is not necessary to summarize all discussion that has led to the development of the study protocol. 
The IRB is interested only in short summaries about experiences or preliminary work that suggest the 
study is feasible and that risks are reasonable relative to the benefits. Examples: You have already 
conducted a Phase 1 study of an experimental drug which supports the Phase 2 study you are now 
proposing to do; you have already done a small pilot study showing that the reading skills 
intervention you plan to use is feasible in an after-school program with classroom aides; you have 
experience with the type of surgery that is required to implant the study device; you have a study 
coordinator who is experienced in working with subjects who have significant cognitive impairment. 
 
 
The FOCUS mHealth intervention has undergone an extensive process of development and 
evaluation in partnership with CMHC patients with SSD and provider stakeholders. 
A. FOCUS: Design and usability. The intervention was developed to provide automated real-
time/realplace illness management support to individuals with SSD (R34MH100195). Patients 
provided ongoing feedback on the look, feel, and content of the intervention throughout the 
development process. 28 Through a series of focus groups and individual interviews, patient and 
CMHC providers helped determine treatment targets and even selected the intervention name. To 
maximize usability, FOCUS was developed in accordance with design principles for electronic 
resources for people with serious mental illness and cognitive impairment. 56 Several iterative 
cycles of usability testing with patients helped inform improvements and hone the system so that it 
would be appropriate for people who may have cognitive deficits, low literacy levels, and limited 
experience with technology. Once installed, FOCUS can be semi-tailored to each user (e.g., name, 
preferred treatment targets, prompting schedule).  

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
Description of the mHealth intervention. FOCUS has three elements:28, 33 1) FOCUS application 
(app): The system includes pre-programmed daily self-assessment prompts as well as on-demand 
functions that can be accessed 24 hours a day. Self-management content was adapted from 
psychosocial intervention strategies targeting five broad domains: 28 Voices (i.e., coping with 
auditory hallucinations via cognitive restructuring, distraction, guided hypothesis testing), Mood 
(i.e., anaging depression and anxiety via behavioral activation, relaxation techniques, supportive 
content), Sleep (i.e., sleep hygiene, relaxation, health and wellness psychoeducation), Social (i.e., 
cognitive restructuring of persecutory ideation, anger management, activity scheduling, skills 
training), and Medication (i.e., behavioral tailoring, reminders, psychoeducation). The system uses 
audio prompts, video content, cartoons, and written text to deliver coping strategies in the form of 
interactive questions, suggestions, and guided demonstrations. Content can be accessed as either 
brief video or audio clips or sequences of digital screens with written material coupled with visual 
displays; 2) Clinician dashboard: FOCUS users9 responses to daily self-assessments are securely 
transmitted to a remote server. The information is processed and displayed on an online dashboard 
with a real-time summary of engagement, module selection, and reported symptom severity over 
the last 7 days, that is accessible to authorized staff who use it to inform and enhance their clinical 
services. If, dashboard data suggest a patient requires additional assistance, staff call to assess 
further and provide consultation ; 3) mHealth support personnel: FOCUS patients are engaged 
throughout the treatment period by trained individuals to encourage their adherence to FOCUS by 
assisting them in all technical and clinical aspects of the intervention. 
 
B. FOCUS: Feasibility, acceptability, and efficacy. FOCUS was deployed among individuals with SSD 
(n=43) receiving services from CMHCs in Illinois 33 and Vermont. 31 FOCUS feasibility, acceptability, 
satisfaction, and efficacy outcomes were very promising. Results: Participants learned to use the 
intervention with ease. On average, participants used FOCUS 4.8 times a day, 6 days a week. Across 
both trials, approximately 60% of FOCUS use was self-initiated by patients (<on-demand= functions). 
This finding is important, given that participants were not incentivized to engage, and their access 
to other smartphone resources was not dependent on their use of FOCUS. Approximately 90% of 
participants rated the intervention as highly acceptable, usable, and engaging. The smartphone 
multi-media elements proved to be highly engaging to participants (e.g., as reported in qualitative 
interviews: <[The intervention] was like having a friend check in with you. When I watched the 
videos it made it feel more personal]=.31 Baseline levels of cognitive functioning, negative 
symptoms, and persecutory ideation did not impede participants9 use of FOCUS. Efficacy: 
FOCUS use led to statistically significant and clinically meaningful reductions in psychotic symptoms 
(PANSS positive symptom scale, Cohen9s d=.70), depression (BDI-II Cohen9s d=.50), and general 
psychopathology (PANSS psychopathology scale, Cohen9s d=.73). Relevance for implementation: 
Although FOCUS demonstrated strong usability, feasibility, and efficacy in trials where our research 
staff identified, recruited, and monitored (via the clinician dashboard) study participants from 
CMHCs, there are substantial opportunities to increase reach and impact of the intervention by 
helping CMHC clinical staff and administrators integrate FOCUS into their routine care regimen for 
patients with SSD. In our field trials FOCUS was a siloed research activity—CMHC clinicians did not 
have access to their patients9 data and were not <in the loop= of intervention activity. Engaging 
CMHC providers in the mHealth intervention would create opportunities to integrate FOCUS 
into practice and make meaningful use of their patients9 data (i.e. inform in person services, better 
understand their illness profile and needs, encourage FOCUS engagement), which in turn may 
enhance mHealth implementation. 57 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
C. FOCUS: Effectiveness and readiness for implementation (pilot EF). We conducted a comparative 
effectiveness trial (RCT) 35 comparing FOCUS to a widely used an evidence-based group 
intervention (WRAP) in community mental health settings (n=163) (PCORI CER140311403). Results: 
FOCUS participants had better treatment commencement (90% vs. 58%), better continuous full 
engagement in treatment, equivalent (high) treatment satisfaction, and equivalent significant 
improvement in clinical outcomes: general psychopathology (SCL-9 Cohen9s d=.44) depression (BDI-
2 Cohen9s d=.31), and recovery (RAS Cohen9s d=.38). These moderate/large effects are clinically 
meaningful and comparable to more time/labor/resource intensive clinic based interventions.36 
Patients rated the FOCUS intervention supported by EF as highly acceptable. Dropout in the FOCUS 
arm was very low (3.5%). Engagement was associated with clinical outcomes: more weeks of full 
engagement (defined as 5+ days of weekly use) were significantly associated with larger increases in 
recovery scores post-treatment. Patients who completed at least 8+ <fully engaged= weeks showed 
greater improvements in general psychopathology, depression, and recovery than those who did 
not. Relevance for implementation: CMHC providers and organizational leaders indicated a strong 
acceptability and interest in adoption and integration of mHealth in their programs. These findings 
were supported by responses to implementation survey items (rated 1-<Not at all= to 5-<Very 
Much=): I would be supportive of incorporating FOCUS into standard practice at my agency: M= 4.9; 
Connecting with clients through their smartphones would improve their quality of care: M=3.9; 
Connecting with clients through smartphone intervention would make me more effective in my job: 
M=4.25). Relevance for implementation: The FOCUS intervention required training and supervision 
of a single external facilitator who engaged with 
patients and supported and trained CMHC providers from a centralized location. The EF was not 
part of the CMHC clinical staff but hired and trained specifically for this role. 58 The clinical training 
materials and supervision structure was adapted and refined over the course of the 3-year study. 
The EF served as the point of contact, FOCUS trainer, and mHealth supporter for patients and staff. 
The facilitator met with participants at the beginning of the intervention to build rapport and to 
provide smartphone and FOCUS training. All other interactions were conducted remotely, 
successfully. 
D. FOCUS: Multi-site deployment (pilot IF). With funding from the Center for Medicare and 
Medicaid Innovation (C1MS331052) FOCUS was used in conjunction with a treatment offered to 
people with SSD who were recently discharged from a psychiatric hospitalization. 59 This effort was 
conducted in partnership with CMHCs in eight states and constitutes the largest deployment of an 
mHealth intervention for people with SSD to date (n=342). 33 Clinical staff members at each site 
were selected and trained as internal practice facilitators to serve as the primary point of contact 
for patients, provided technical troubleshooting and smartphone configuration services, and served 
as the local mHealth champion and resource for treatment teams. 59, 60 
Results were promising: Participants engaged with FOCUS on 82% of the weeks they had the 
smartphone and 44% used the intervention over 5-6 months, on average 4.3 days a week. 
Relevance for implementation: All study sites were able to identify personnel to serve as internal 
facilitators, all facilitators successfully completed training with our study team before commencing 
IF activities at their agencies, CMHC staff were able to log on, understand, and use the FOCUS 
clinical dashboard successfully. Notably, on-site CMHC personnel identified FOCUS candidates, and 
the vast majority of patients in the relapse prevention program who were offered FOCUS agreed to 
use it (92%). While the uptake and patient engagement findings were encouraging in terms of 
feasibility of the IF model, it was not structured as a controlled experimental study; there was no 
implementation comparator arm, it was impossible to isolate the mHealth-specific facilitator costs, 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
or to determine the relative impact of more resource-intensive internal facilitation on patient 
outcomes relative to EF. 
1.9 Supplements. Check all boxes that apply, to identify Supplements you should complete and upload to 
the Supporting Documents SmartForm in Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this 
IRB Protocol form that you will need to provide in these Supplements. 
 
Check all 
That 
Apply 
Type of Research 
Supplement Name 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, 
data, or personnel. 
ZIPLINE 
SUPPLEMENT: 
Department of 
Defense 
 
 
 
 
 
 
 
 
PAPER SUPPLEMENT 
Department of 
Defense 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, 
data, or personnel. 
ZIPLINE and PAPER 
SUPPLEMENT: 
Department of 
Energy 
 
 
 
 
 
 
 
 
 
 
 
 
Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of your research 
ZIPLINE 
SUPPLEMENT: Drugs 
 
 
 
 
 
 
 
 
PAPER SUPPLEMENT: 
Drugs 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research 
involving more than minimal risk 
ZIPLINE 
SUPPLEMENT: 
Exception from 
Informed Consent for 
Emergency Research 
(EFIC) 
 
 
 
 
 
 
 
 
 
 
 
 
Genomic data sharing 
Genomic data are being collected and will be deposited in an 
external database (such as the NIH dbGaP database) for sharing 
with other researchers 
ZIPLINE 
SUPPLEMENT: 
Genomic Data 
Sharing 
 
 
 
 
 
 
 
 
PAPER SUPPLEMENT: 
Genomic Data 
Sharing 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the 
device is not the focus of your research, except when the device is 
FDA-approved and is being used through a clinical facility in the 
manner for which it is approved 
ZIPLINE 
SUPPLEMENT: 
Devices 
 
 
 
 
PAPER SUPPLEMENT: 
Devices 
 
 
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
 
 
Multi-site study 
(You are asking the UW IRB to review one or more sites in a multi-
site study.) 
ZIPLINE 
SUPPLEMENT: 
Participating Site in 
Multi-Site Research 
 
 
 
 
 
 
 
 
 
 
 
 
Participant results sharing 
Individual research results will be shared with subjects. 
ZIPLINE 
SUPPLEMENT: 
Participant Results 
Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
x 
 
 
 
 
 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
Patient participants will all be over the age of 18, include all genders, use English, own a smartphone 
with data plan has a diagnosis of schizophrenia-spectrum disorders and receive services from a 
participating clinic.   
2.2 Inclusion and exclusion criteria. Describe the criteria you will use to decide who will be included in your 
study from among interested or potential subjects. Define any technical terms in lay language. 
 
Patient inclusion criteria: a) Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, 
schizotypal disorder, delusional disorder, or schizophreniform disorder; b) 18 years or older; c) English-
speaking; d) Own a smartphone that can support FOCUS and active data plan.  
 
Patient exclusion criteria: 1) Used FOCUS in the past; 2) Plan to move or discontinue CMHC services in 
the upcoming 6 months.  
 
CMHC staff will be asked to complete an online survey evaluating implementation outcomes and clinic 
characteristics.  Staff from CMHC administration/budget/finance offices will also help inform costing 
through the use of de-identified data.  
 
Staff inclusion criteria: a) Staff members at a participating study site; b) 18 years or older.  
 
 
2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not 
an intended target population. 
a. Do you intend to deliberately recruit prisoners or obtain prisoner data/specimens? 
See the WORKSHEET: Prisoners for the definition of <prisoner=.   
 
x No 
 
 
 
Ye
s 
→ If yes, describe the type of prisoners, and which prisons/jails. 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
      
 
b. Is your research likely to have subjects who become prisoners while participating in your study?   
For example, a longitudinal study of youth with drug problems is likely to have subjects who will be 
prisoners at some point during the study. 
 
x No 
 
 
 
Yes 
→ If yes, if a subject becomes a prisoner while participating in your study, will you 
continue the study procedures and/or data collection while the subject is a prisoner? 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe the procedures and/or data collection you will continue 
with prisoner subjects 
 
 
 
      
2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check 
the boxes for any of these populations that you will purposefully include in your research. (In other 
words, being a part of the population is an inclusion criterion for your study.) 
The WORKSHEETS describe the criteria for approval.   
 
Population 
Worksheet 
 
 
Children 
WORKSHEET: Children 
 
 
 
 
 
 
Children who are wards 
WORKSHEET: Children 
 
 
 
 
 
 
Cognitively impaired adults 
 
 
 
 
 
 
 
Fetuses in utero 
WORKSHEET: Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET: Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET: Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET: Pregnant Women 
 
 
 
 
<Children= are defined as individuals who have not attained the legal age for consent to treatments or 
procedures involved in the research and its specific setting. This will vary according to the location of the 
research (that is, for different states and countries). 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
a. If you check any of the boxes above, use this space to provide any information you think may be 
relevant for the IRB to consider.  
 
 
2.5 Native Americans or non U.S. indigenous populations. Will you actively recruit from Native American or 
non-U.S. indigenous populations through a tribe, tribe-focused organization, or similar community-based 
organization? 
Indigenous people are defined in international or national legislation as having a set of specific rights 
based on their historical ties to a particular territory and their cultural or historical distinctiveness from 
other populations that are often politically dominant.  
 
Examples:  a reservation school or health clinic; recruiting during a tribal community gathering 
 
x 
No  
 
 
Ye
s 
→ If yes, name the tribe, tribal-focused organization, or similar community based 
organization. The UW IRB expects that you will obtain tribal/indigenous approval before 
beginning your research. 
 
 
 
 
      
2.6 Third party subjects. Will you collect private identifiable information about other individuals from your 
subjects? Common examples include: collecting medical history information or contact information 
about family members, friends, co-workers. 
<Identifiable= means any direct or indirect identifier that, alone or in combination, would allow you or 
another member of your research team to readily identify the person. For example, suppose that you 
are studying immigration history. If you ask your subjects several questions about their grandparents but 
you do not obtain names or other information that would allow you to readily identify the grandparents, 
then you are not collecting private identifiable information about the grandparents.  
 
x 
No 
 
 
 
Yes 
→ If yes, these individuals are considered human subjects in your study. Describe them and 
what data you will collect about them. 
 
 
 
 
      

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
2.7 Number of subjects. Can you predict or describe the maximum number of subjects (or subject units) you 
need to complete your study, for each subject group? 
Subject units mean units within a group. For most research studies, a group will consist of individuals. 
However, the unit of interest in some research is not the individual. Examples:   
• Dyads such as caregiver-and-Alzheimer9s patient, or parent and child 
• Families 
• Other units, such as student-parent-teacher 
Subject group means categories of subjects that are meaningful for your research. Some research has 
only one subject group – for example, all UW students taking Introductory Psychology. Some common 
ways in which subjects are grouped include: 
• By intervention – for example, an intervention group and a control group. 
• By subject population or setting – for example, urban versus rural families 
• By age – for example, children who are 6, 10, or 14 years old.  
 
The IRB reviews the number of subjects you plan to study in the context of risks and benefits. You may 
submit a Modification to increase this number at any time after you receive IRB approval. If the IRB 
determines that your research involves no more than minimal risk: you may exceed the approved 
number and it will not be considered non-compliance. If your research involves more than minimal risk: 
exceeding the approved number will be considered non-compliance.  
 
 
No → If no, provide your rationale in the box below. Also, provide any information you can about 
the scope/size of the research. You do not need to complete the table. 
 
 
 
 
Example: you may not be able to predict the number of subjects who will complete an 
online survey advertised through Craigslist, but you can state that you will post your survey 
for two weeks and the number who respond is the number who will be in your study. 
 
 
      
 
x Yes → If yes, for each subject group, use the table below to provide your estimate of the 
maximum desired number of individuals (or other subject unit, such as families) who will 
complete the research. 
 
 
 
Group name/description 
Maximum desired number of individuals (or 
other subject unit, such as families) who will 
complete the research 
*For clinical trials: provide numbers for your 
site and for the study-wide total number 
 
Patients with SSD  
300 
 
Staff 
200 
 
 
 
 
      
      
 
      
      
 
      
       
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
3 INTERNATIONAL RESEARCH SETTING 
Answer the questions in this section ONLY if your research will occur at sites outside of the United 
States 
3.1 Reason for sites. Describe the reason(s) why you selected the sites where you will conduct the research. 
 
N/A 
3.2 Local context. Culturally-appropriate procedures and an understanding of local context are an important 
part of protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may 
affect your research or how it is conducted. 
Examples: It would be culturally inappropriate in some international settings for a woman to be directly 
contacted by a male researcher; instead, the researcher may need to ask a male family member for 
permission before the woman can be approached. It may be appropriate to obtain permission from 
community leaders prior to obtaining consent from individual members of a group. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  
 
N/A 
3.3 Site-specific laws. Describe any local laws that may affect your research (especially the research design 
and consent procedures). The most common examples are laws about: 
• Specimens – for example, some countries will not allow biospecimens to be taken out of the 
country. 
• Age of consent – laws about when an individual is considered old enough to be able to provide 
consent vary across states, and across countries.   
• Legally authorized representative – laws about who can serve as a legally authorized representative 
(and who has priority when more than one person is available) vary across states and countries. 
• Use of healthcare records – many states (including Washington State) have laws that are similar to 
the federal HIPAA law but that have additional requirements. 
 
N/A 
3.4 Site-specific administrative or ethical requirements. Describe local administrative or ethical 
requirements that affect your research.  
Example: A school district may require you to obtain permission from the head district office as well as 
school principals before approaching teachers or students; a factory in China may allow you to interview 
factory workers but not allow you to pay them.  
 
N/A 
 
 
4 RECRUITING and SCREENING PARTICIPANTS 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
4.1 Procedures. Describe how you will identify, recruit, and screen subjects. Include information about: 
how, when, where, and in what setting. Identify who (by position or role, not name) will approach and 
recruit subjects, and who will screen them for eligibility.   
 
Mental health providers will describe the study to their patients to gauge interest- clinicians will  obtain 
interest and will pass along contact information to the research team from interested patients or will 
provide the study URL (hosted by Qualtrics) for patient9s to enter their contact, express interest and 
assess eligibility.  
 
Patient Participants will be identified based on a protocol previously used by the Washington State 
CMHC implementation effort.  
 
The protocol entails coordinating with middle managers and IT staff at each agency to audit Electronic 
Health Records (EHRs) by diagnosis. This procedure generates a list of active patients who meet 
diagnostic inclusion criteria. <Active status= is defined by the research team as seen in the CMHC for 
services within the several months. For agencies that lack the capability to execute a search by 
diagnosis among active patients, caseload audits are delegated to the treatment teams.  
 
Once the <active status= list has been generated, it will then be given to care coordinators or treatment 
team leaders along with a script to introduce the study to eligible individuals, provide a brief verbal 
introduction to the study along with a 1-page handout prepared by the research team.  
 
Patients can indicate their interest through accessing a secure study webpage (hosted by Qualtrics) or 
by giving permission to their clinician to pass along their contact information to the research team. On 
the study webpage they will be asked for their first and last name, phone number, the clinic they 
currently receive care from and to answer 3 inclusion questions + interest in future studies; 1. If they 
have a smartphone with data plan that can support the FOCUS app, 2. If they have ever used FOCUS 
before, and 3. If they plan to leave treatment in the next 6 months. 4. If they are interested in being 
informed about future research studies.  
 
Consent forms will be available to potential participants in one of three ways; 1. They can pick up a 
printed form at the participating clinic, and/or 2. A copy can be downloaded from the study webpage, 
and/or 3. Emailed/texted to the potential participant before research staff reach out via phone.  
 
After receiving interest of a potential participant and consent form has been received researchers 
would then reach out via phone call to provide a more comprehensive description of the project, 
screening, and informed consent. Participants will be fully informed that they are free to stop their 
participation at any time. Candidates will need to pass a brief quiz testing their understanding that 
participation is completely voluntary. Participants will be required to answer questions demonstrating 
that they understand what type of data will and will not be collected from them over the upcoming 
months (self-report and FOCUS use data). Each question will need to be answered correctly before 
individuals can proceed to provide consent. Individuals who commence the study will be assigned to 
their sites practice facilitator (external or internal). Randomization will occur at the site level with equal 
representation of urban and rural settings in each implementation arm. 
 
Staff Participants who will participate in on-site data collection evaluating implementation outcomes 
and clinic characteristics will be purposively selected from CMHC (both study arms) and from CMHC 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
administration/budget/finance offices (for costing). The assessment evaluating implementation 
outcomes will be fully explained to staff participants via webpage (hosted by Qualtrics), where staff can 
check a box to indicate they are willing to participate. Assessments time points will be at 0M (prior to 
their patient beginning treatment), then at roughly 3M (time-point after the patient completes 
treatment). The confidential survey takes 20-30 minutes to complete (questions are included in the 
supportive documents) and staff will be compensated $20 in the form of an Amazon gift card for their 
time.  Staff key informants will complete interviews with a trained member of the research team 
related to costing, including questions about services and effort put towards the study. Key informant 
interviews will last approximately 60 minutes and be audio-recorded, and later transcribed. Numbers 
will be provided at aggregate levels, or if treatments were specified, would not identify the individual.  
4.2 Recruitment materials.  
 
a. What materials (if any) will you use to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; 
social media messages; written materials such as letters, flyers for posting, brochures, or printed 
advertisements; questionnaires filled out by potential subjects. 
 
 
1-page handout summarizing the study (included) 
 
 
b. Upload descriptions of each type of material (or the materials themselves) to the Consent Forms and 
Recruitment Materials SmartForm of Zipline. If you will send letters to the subjects, the letter should 
include a statement about how you obtained the subject9s name, contact information, and any other 
subject-specific information (such as a health condition) that is mentioned in the letter.  
HSD encourages researchers to consider uploading descriptions of most recruitment and screening 
materials instead of the materials themselves. The goal is to provide the researchers with the flexibility 
to change some information on the materials without submitting a Modification for IRB approval of the 
changes. Examples: 
• You could provide a list of talking points that will be used for phone or in-person conversations 
instead of a script.   
• For the description of a flyer, you might include the information that it will provide the study 
phone number and the name of a study contact person (without providing the actual phone 
number or name). In doing so, you would not need to submit a Modification if/when the study 
phone number or contact person changes. Also, instead of listing the inclusion/exclusion criteria, 
you might state that the flyer will list one or a few of the major inclusion/exclusion criteria. 
• For the description of a video or a website, you might include a description of the possible visual 
elements and a list of the content (e.g., study phone number; study contact person; top three 
inclusion/exclusion criteria; payment of $50; study name; UW researcher).  
4.3 Relationship with participant population. Do any members of the study team have an existing 
relationship with the study population(s)?  
Examples: a study team member may have a dual role with the study population (for example, being 
their clinical care provider, teacher, laboratory directory or tribal leader in addition to recruiting them for 
his/her research). 
 
x No 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
Ye
s 
→ If yes, describe the nature of the relationship. 
 
 
 
 
4.4 Payment to participants. Describe any payment you will provide, including: 
• The total amount/value 
• Whether payment will be <pro-rated= so that participants who are unable to complete the research 
may still receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include 
information about the number and amount of payments, and especially the time when subjects can 
expect to receive payment. One of the most frequent complaints received by HSD is from subjects who 
expected to receive cash or a check on the day that they completed a study and who were angry or 
disappointed when payment took 6-8 weeks to reach them.  
 
Do not include a description of any expenses that will be reimbursed.  
Patient baseline assessment $30+$10 travel or data plan 
Patient post-trial assessment $30+ $10 travel or data plan 
Patient follow-up assessment $30+ $10 travel or data plan 
Staff assessment: $20 
 
 
4.5 Non-monetary compensation. Describe any non-monetary compensation you will provide. Example: 
extra credit for students; a toy for a child. If you will be offering class credit to students, you must 
provide (and describe) an alternate way for the students to earn the extra credit without participating in 
your research.  
N/A. 
4.6 Consent for recruiting and screening. Will you obtain consent for any of the recruiting and screening 
procedures? (Section 8: Consent of Adults asks about consent for the main study procedures). 
<Consent= includes: consent from individuals for their own participation; parental permission; assent 
from children; consent from a legally authorized representative for adult individuals who are unable to 
provide consent. 
 
Examples:   
• For a study in which names and contact information will be obtained from a registry: the registry 
should have consent from the registry participants to release their names and contact 
information to researchers. 
• For a study in which possible subjects are identified by screening records: there will be no 
consent process.  
• For a study in which individuals respond to an announcement and call into a study phone line: the 
study team person talking to the individual may obtain non-written consent to ask eligibility 
questions over the phone.  
 
 
No 
→ If no, you must still answer question 4.7 below. 
 
x Yes 
→ If yes, describe the consent process. 
 
 
 
Eligibility criteria may be obtained over the phone by a study staff member, referred to 
the research team from clinical staff or through the online webpage after the potential 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
participant has been referred to the study. Information includes: name, contact 
information, age, if they own a smartphone / data plan, used FOCUS in the past, or plan to 
discontinue services over the next 6 months. For staff: age, confirmation they work for a 
participating study site.  
 
a. Documentation of consent. Will you obtain a written or verifiable electronic signature 
from the subject on a consent form to document consent for the recruiting and 
screening procedures? 
 
x No 
→ If no, describe the information you will provide during the consent process 
 
 
 
 
It would be impossible to obtain written screening consent with 
potential participants over the phone. We request a waiver of consent 
for the screening process.  
 
 
Yes → If yes, upload the consent form to the Consent Forms and Recruitment 
Materials page of Zipline. 
 
 
 
4.7 Data and specimens. For studies where you will obtain consent, describe any data and/or specimens 
(including any PHI) you will obtain prior to obtaining consent and whether you will retain it as part of the 
study.  
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice 
recording, etc.) for research purposes and to retain for any length of time. 
 
Examples: names and contact information; the information gathered from records that were screened; 
results of screening questionnaires or screening blood tests; Protected Health Information (PHI) from 
screening medical records to identify possible subjects. 
 
A list of active participants will be generated either through culling EMR data or talking with clinical 
teams that will serve as the primary list for their clinical teams to approach to describe the study and 
gauge interest.  
 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including 
the sequence, intervention or manipulation (if any), time required, and setting/location. If it is available 
and you think it would be helpful to the IRB: Upload a study flow sheet or table to the Supporting 
Documents SmartForm in Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. 
See UW IRB POLICY: Risks of Harm from Standard Care and the draft guidance from the federal Office of 
Human Research Protections, <Guidance on Disclosing Reasonably Foreseeable Risks in Research 
Evaluating Standards of Care=; October 20, 2014. 
 
About the study: 
This study is a multi-site site hybrid type III effectiveness/implementation study. The intention of this 
study is to examine the delivery of FOCUS within two treatment models. One, where the app is 
delivered through an internal facilitator embedded within a mental health clinic (study site), the other, 
involves an external facilitator delivering the intervention (staff at UW). Both facilitators help 
participants install, use, and incorporate the app9s strategies into their own coping skillset.  
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
The project will involve recruiting outpatients with schizophrenia spectrum disorder who receive 
mental health services at CMHCs in WA for participation in a randomized controlled trial (15 at each 
CMHC; n=300). Patient participants will engage in a 3-month long mHealth intervention called FOCUS 
which involves use of a smartphone system in their own environment and weekly phones calls with a 
practice facilitator that is based at the UW (EF model) or the CMHC where they receive care (IF model). 
Participants enrolled in the IF arm may also have in-person meetings with their agency-facilitator at 
their CMHC or in the community.  
 
 
Arm I: All the same research procedures as ARM II, FOCUS delivery to participants is through an Internal 
Facilitator (staff member of study site who is identified and trained to serve as a navigator to the FOCUS 
app (technology, program use and application of strategies to their treatment plan)).  
 
Arm II: All the same research procedures as ARM I, FOCUS delivery to participants is through an External 
Facilitator (UW staff who will be trained to serve as a navigator to the FOCUS app (technology, program 
use and application of strategies to their treatment plan)).  
 
 
Description of the mHealth intervention: 
FOCUS has three elements: 1) FOCUS application (app): The system includes pre-programmed daily self-
assessment prompts as well as on-demand functions that can be accessed 24 hours a day. Self-
management content was adapted from psychosocial intervention strategies targeting five broad 
domains:  Voices (i.e., coping with auditory hallucinations via cognitive restructuring, distraction, guided 
hypothesis testing), Mood (i.e., anaging depression and anxiety via behavioral activation, relaxation 
techniques, supportive content), Sleep (i.e., sleep hygiene, relaxation, health and wellness 
psychoeducation), Social (i.e., cognitive restructuring of persecutory ideation, anger management, 
activity scheduling, skills training), and Medication (i.e., behavioral tailoring, reminders, 
psychoeducation). The system uses audio prompts, video content, cartoons, and written text to deliver 
coping strategies in the form of interactive questions, suggestions, and guided demonstrations. Content 
can be accessed as either brief video or audio clips or sequences of digital screens with written material 
coupled with visual displays; 2) Clinician dashboard: FOCUS users9 responses to daily self-assessments 
are securely transmitted to a remote server. The information is processed and displayed on an online 
dashboard with a real-time summary of engagement, module selection, and reported symptom severity 
over the last 30 days, that is accessible to authorized staff who use it to inform and enhance their 
clinical services. If, dashboard data suggest a patient requires additional assistance, staff call to assess 
further and provide consultation ; 3) mHealth support personnel: FOCUS patients are engaged 
throughout the treatment period by trained individuals to encourage their adherence to FOCUS by 
assisting them in all technical and clinical aspects of the intervention. 
 
FOCUS data will be used directly by the IF / EF to inform their weekly calls with participants. A summary 
of FOCUS data use may also be shared with their clinicians to inform their care / treatment plans. 
Weekly phone calls will be used to assess if there are any technical issues experienced by the 
participant, along with resolving that issue. IF/EF9s will also talk about the FOCUS app use over the 
previous week and how they can use the tips/ strategies to support their goals. Each weekly call should 
last approx. 10-15 minutes.  
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
Study Sites 
Randomization will occur at the level of the clinic and will be balanced within study arm by number of 
patients served and rural/urban designation. Study sites (k=20) will vary in staffing and services 
capacity. Sites will either be randomized to have an internal facilitator (IF) or external facilitator (EF). 
The internal and external facilitators will work to engage participating organizations, practitioners, and 
patients throughout the study which includes sending email and placing phone calls with participating 
organizations, practitioners and patients in order to conduct the study (i.e., schedule appointments, 
request materials, etc.). They will provide updates about study progress and will maintain and request 
data from the study sites.  
 
 
Patient Participants 
 
After consenting into the study, patient participants will receive a phone call prior to each assessment 
(0M, 3M, 6M) letting them know they will receive a text or email (for those who have identified trouble 
receiving text messages) with the assessment URL and to provide instructions for how to complete the 
assessment (ensure they are in a private place, have reliable data for transmission, will take aprox. 20-
30 minutes to complete, etc). Participants will then receive the web-based baseline assessment via text 
and will be asked to complete it in a private and quiet space.  For those who have expressed difficulty 
completing the assessment through the web-based assessment, a phone call can be conducted with 
trained assessor to ask questions directly over the phone. Afterward, they will be asked to meet with 
their assigned facilitator (IF/ EF) to install the FOCUS app on their phone, describe how to use it and set 
up a time for their weekly calls. This may be done via phone call, or video call, whichever is preferred by 
the participant.  Participants will continue to use the program for 3 months in their own environments, 
along with participating in weekly calls to discuss what they9ve learned in the FOCUS app and how those 
strategies can help support their symptom coping strategies.  
 
The FOCUS application uninstalls at 3 months and then the 3 month web-based outcome assessment 
will be sent via text and will ask participants to complete it in a private and quiet space. Once again 
those who express difficulty completing the assessment through the web-based platform can request a 
call with an assessor on the research team. Participants who complete treatment will be mailed out a 
certificate of completion to their home address or clinic (based on participant9s choice). They will no 
longer have access to the app, nor will participate in weekly calls for the next 3 months. They would 
then be sent another assessment at 6 months to complete.  
 
Patient Participant Assessment: 
Patient participants will receive a text from researchers just before their assessment date providing 
instructions on how to complete the online assessment. They will then be invited to conduct 
assessments at 0, 3, and 6 months via embedded link to a secure study portal (Qualtrics).  For 
participants who need additional assistance, they can come into the participating clinic to complete on 
a tablet provided by the research team. Patient participants will receive $30 compensation for each 
completed assessment (estimated completion time < 45 minutes) for a maximum of $90 compensation 
(Plus additional $10 each assessment to compensate data transmission or travel to site if more 
assistance is necessary). All participants will be paid for each assessment, but they will not be 
compensated for engagement in the intervention; assessments are administered to everyone enrolled 
in the study regardless of how/whether they engaged in FOCUS (note: all patient participants own 
working smartphones as part of inclusion criteria).  

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
Assessments include questions about psychiatric treatment and hospitalizations, along with other 
measures of mental health including depression, anxiety, hearing voices, and recovery: 
 
• Demographics and other characteristics 
• PhQ9 
• GAD-7 
• Hospitalization- days hospitalized, no identifiers will be captured. 
• ISI: Insomnia Severity Index 
• Green Paranoid Thoughts Scale 
• Symptom Checklist SCL-9Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)  
• Recovery Assessment Scale (RAS)  
• Illness Management Recovery Scale (IMRS) 
• Working Alliance Inventory (3M only) 
• mHealth Mastery Measure (3M only) 
• AIM 
• Satisfaction  
 
Information we plan to collect from EMR data: 
 
• A list of active participants will be generated either through culling EMR data or talking with 
clinical teams that will serve as the primary list for their clinical teams to approach to describe 
the study and gauge interest. 
• Services billed- no identifiers will be shared with the research team 
 
 
 
Mental Health Provider Participants:  
Select mental health providers will be invited to complete an online assessment with the research 
team. Staff participants will be invited to complete a confidential online survey. This includes exposure 
to the FOCUS app, if strategies or the program was incorporated into their treatment plans, and 
perceptions of how the program was adopted and implemented at their clinic.  
 
       Mental Health Provider Assessment:  
 
Providers who receive FOCUS data 
• Offered mHealth, i.e., the percent of each practitioner9s eligible patients who are offered FOCUS 
• Treatment Initiation, i.e., percent of consenting patients who followed their practitioner9s 
guidance and went on to download FOCUS onto their smartphone and interact with the system 
at least once. Dashboard Use, i.e., the average number of times each practitioner logs on to the 
online FOCUS dashboard to view their individual patients9 uploaded FOCUS data 
 
The following will be captured via online confidential** survey (Qualtrics): 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
• The perception among practitioners that an innovation is agreeable, palatable, or satisfactory. 
(Measured via AIM / IAM / FIM). 
• ORIC: Organizational Readiness for Implementing Change 
 
Providers at the clinic who may not have been directly involved with the FOCUS Intervention (to provide 
contextual factors) through online confidential survey (Qualtrics): 
• Organizational Readiness to Change Assessment (ORCA) 
o CMHC staff participants will complete 23 items using a 5-point bipolar rating scale (1-
Strongly agree to 5-Strongly disagree). Constructs evaluated include clinical cooperation 
within the practice, clarity in patient care goals and process, level of support (e.g., 
training, budget, staffing) and typical receptivity to guidance (staff) and feedback 
(leadership). 
• Absorptive capacity will be measured among CMHC practitioners who were engaged in IF or EF 
implementation at 0, 3, and 6 months using the 14-item ACAP Scale.  
o The ACAP Scale evaluates dimensions of absorptive capacity including  
▪ Acquiring (e.g., searching for new information, motivation to use information) 
▪ Assimilating (e.g., communication of new ideas and concepts across stakeholders, 
cross departmental sharing of information) 
▪ Transforming (e.g. ability to structure and use collected information, linking 
existing knowledge with new insights, applying new knowledge to practical work), 
and  
▪ Exploiting new knowledge in practice (e.g., adapting practices according to new 
knowledge, working more effectively by adopting new technologies) 
• IF/EF self-report: Clinicians will report the number of access points to the clinician dashboard, 
distribution of weekly reports to the clinical team, and correspondence of data derived from the 
dashboard to treatment targets. 
 
• **IP addresses are collected by Qualtrics which may or may not be potentially identifiable, but 
will not be used by the research team as data.  
 
Key informant interviews related to costing procedures will also be completed at a select number of study 
locations. Interviews will be conducted remotely by a trained research team member. Questions will be related 
to time, effort, and resources dedicated to the study. Interviews will last approximately 60 minutes, and be 
audio-recorded and later transcribed. 
 
5.2 Data sources. For all types of data that you will access or collect for this research: Identify whether you 
are obtaining the data from the subjects (or subjects9 specimens) or whether you are obtaining the data 
from some other source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information 
here. 
 
 
1) Self-report and interview-based measures obtained directly from CMHC staff participants by trained 
evaluators about services billed for and time allocation (for costing only). 
2) mHealth engagement data recorded by the FOCUS system and uploaded to a secure server.  

24 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
3) Self report symptom and self-management ratings obtained via Qualtrics survey. 
4) Confidential staff questionnaire responses via Qualtrics. 
• **IP addresses are collected by Qualtrics which may or may not be potentially identifiable, but 
will not be used by the research team as data.  
 
 
5.3 Retrospective/prospective. For all types of data and specimens that you will access or collect for this 
research: Describe which data are: 
• Retrospecitve (i.e., exist at the time this application is sent to HSD) 
• Prospective (do not yet exist) 
• Both retrospective and prospective (for example, past and future school records) 
 
Retrospective Only: 
- patient care status (still receiving services at study site).  
 
Prospective Only: 
- Assessment measures 
- FOCUS app use data 
 
5.4 Identifiability of data and specimens. Answer these questions carefully and completely. This will allow 
HSD to accurately determine the type of review that is required and to assist you in identifying relevant 
compliance requirements. Review the following definitions before answering the questions: 
Access means to view or perceive data, but not to possess or record it. See, in contrast, the definition of 
<obtain=. 
Identifiable means that the identify of an individual is or may be readily (1) ascertained by the 
researcher or any other member of the study team from specific data variables or from a combination of 
data variables, or (2) associated with the information.  
Direct identifiers are direct links between a subject and data/specimens. Examples include (but are not 
limited to): name, date of birth, medical record number, email or IP address, pathology or surgery 
accession number, student number, or a collection of your data that is (when taken together) 
identifiable.  
Indirect identifiers are information that links between direct identifiers and data/specimens. Examples: 
a subject code or pseudonym.   
Key refers to a single place where direct identifiers and indirect identifiers are linked together so that, 
for example, coded data can be identified as relating to a specific person. Example: a master list that 
contains the data code and the identifiers linked to the codes. 
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice 
recording, etc.) for research purposes and to retain for any length of time. This is different from 
accessing, which means to view or perceive data.  
a. Will you or any members of your team have access to any direct or indirect identifiers? 
 
x 
Yes 
→ If yes, describe which identifiers and for which data/specimens.  
 
 
 
The research team will have access to the following direct identifiers: participant 
names, contact information (phone number, address, email), emergency family 

25 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
member contact information. The research team will also have access to the key 
and study identifiers. 
 
We will collect audio recordings of costing interviews with key informants (select 
study site staff). The recordings will include the voice of the key informant and 
may contain their name and place of work in the course of the interview. After 
transcribing the audio recordings, the recordings will be destroyed. 
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not have 
access to direct or indirect identifiers. 
 
 
 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before you have 
access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the 
identifiers (or key) that prohibits the release of the identifiers (or key) to you 
under any circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. Examples: 
a Data Use Agreement, Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying 
link). This includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or 
key to you. Describe them below.   
 
 
 
 
 
 
      
b. Will you obtain any direct or indirect identifiers? 
 
x 
Yes 
→ If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
The research team will obtain the following direct identifiers: participant names, 
contact information (phone number, address, email), emergency family 
member contact information, . The research team will also have access to the 
key and study identifiers. 
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not have 
access to direct or indirect identifiers. 
 
 
 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before you have 
access.  
 
 
 
 
 
 

26 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
You have (or will have) entered into an agreement with the holder of the 
identifiers (or key) that prohibits the release of the identifiers (or key) to you 
under any circumstances.   
 
 
 
 
You should be able to produce this agreement for IRB upon request. Examples: 
a Data Use Agreement, Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying 
link). This includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or 
key to you. Describe them below.   
 
 
 
 
 
 
      
c. If you obtain any identifiers, indicate how the identifiers will be stored (and for which data). 
 
 
You will store the identifiers with the data. Describe the data to which this 
applies: 
 
x 
 
 
 
 
Identifiers (First and last name, phone number, email address and IP address) 
will be obtained through the study eligibility page (hosted by Qualtrics). Here, 
identifiers will be captured and stored with eligibility criteria (1. If over 18, 2. 
Has a phone with data plan that can support FOCUS, 3. Has never used FOCUS 
before, 4. Confirmation of location they receive services (to verify if a 
participating clinic). The eligibility screener data will be stored separately from 
assessment data (0M, 3M, 6M data).  
 
 
You will store identifiers and study data separately but you will maintain a link 
between the identifiers and the study data (for example, through the use of a 
code). Describe the data to which this applies: 
 
x 
 
 
 
 
Contact information; including name, phone number, family contact 
information, mailing and email addresses will be collected at the time of 
screening and will be stored in a key with study identifiers.  
 
 
These will be stored on secured servers behind firewalls in encrypted 
documents on secured University of Washington computers.   
 
Unidentifiable data collected through the FOCUS app and Qualtrics assessment 
(0M, 3M, 6M) will be stored separately from identifiable data and will be 
identified by study ID or other ID.  
 
 
You will store identifiers separately from the study data, with no link between 
the identifiers and the study data. Describe the data to which this applies: 
 
 
 
 
 
 
 

27 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
d. Research collaboration. Will individuals who provide coded information or specimens for your 
research also collaborate on other activities for this research? If yes, identify the activities and 
provide the name of the collaborator9s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that 
results from the coded information or specimens; and (2) authorship on presentations or 
manuscripts related to this work. 
No 
5.5 Newborn dried blood spots. Will you use newborn dried bloodspots collected in the United States on or 
after March 18, 2015? 
 
x 
No  
 
 
Ye
s 
→ If yes, is this research supported by any federal funding (including any fellowship or career 
development award that provides salary support)? 
 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will ensure that the bloodspots were collected with 
parental permission (in compliance with a 2015 law that applies to federal-
funded research). 
 
 
 
      
5.6 Protected Health Information (PHI). Will you access, obtain, use, or disclose a participant9s identifiable 
PHI for any reason (for example, to identify or screen potential subjects, to obtain study data or 
specimens, for study follow-up) that does not involve the creation or obtaining of a Limited Data Set? 
 
 
No 
→ If no, skip the rest of this question; go to question 5.7 
 
X Yes 
→ If yes, answer all of the questions below. 
 
 
a. Describe the PHI you will access or obtain, and the reason for obtaining it. Be specific. 
 
We will collect participant names, contact information (mailing address, phone number, 
email), and family member contact information (if available- or other emergency 
contact),  
 
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
x 
Yes 
 
c. Describe how you will access or obtain the PHI. Be specific. 
 
We will obtain PHI via study site through phone or video conference, or encrypted 
documents.    

28 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
d. For which PHI will you obtain HIPAA authorization from the subjects by having them sign 
a HIPAA Authorization form, before obtaining and using the PHI?  
 
We no longer plan to capture PHI that would require a signed HIPAA authorization form.  
 
Confirm by checking the box that you will use the UW Medicine HIPAA Authorization 
form maintained on the HSD website if you will access, obtain, use, or disclose UW 
Medicine PHI. 
 
x Confirmed 
 
 
e. For which PHI will you NOT obtain HIPAA authorization from the subjects? 
 
Name, contact information (mailing address, phone number, email), family emergency 
contact, and if they9re still actively receiving services at the study site.  
 
Provide the following assurances by checking the boxes. 
 
 
The PHI will not be reused or disclosed to any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other research 
for which the use or disclosure of PHI would be permitted. 
 
x 
 
 
 
 
You will fulfill the HIPAA <accounting for disclosures= requirement. See UW Medicine 
Privacy Policy #25. THIS IS ONLY FOR UW RECORDS. 
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or 
indirectly, any patient in any report of the research. 
 
 
 
x 
 
 
 
 
5.7 Genomic data sharing. Will you obtain or generate genomic data, as defined by the National Institutes 
of Health (NIH)? See https://gds.nih.gov/13faqs_gds.html. 
 
x No 
 
 
 
Yes 
→ If yes, answer the question below. 
 
a. Is this research funded by NIH through a grant or contract application submitted to NIH 
on or after January 25, 2015? 
 
 
No 
 
 
 
Yes 
→ If yes, you must comply with the NIH Genomic Data Sharing policy. 
Complete the ZIPLINE SUPPLEMENT Genomic Data Sharing and upload it 
to the Supporting Documents SmartForm of Zipline. 
 
 
5.8 Data and specimen sharing/banking. Do you plan to share some or all of the data, specimens, or subject 
contact information with other researchers or a repository/database, or to bank them for your own 
future unspecified research uses? You are strongly encouraged to consider the broadest possible future 
plans you might have, and whether you will obtain consent now from the subjects for future sharing 
or unspecified uses. Answer NO if your only sharing will be through the NIH Genomic Data Sharing 
described in question 5.7. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and 
many journals require data sharing as a condition of publication. <Sharing= may include: informal 
arrangements to share your banked data/specimens with other investigators; establishing a repository 
from which you formally share with others through written agreements; or sending your data/specimens 

29 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
to a third party repository/archive/entity such as the NIH dbGaP database, the Social Science Open 
Access Repository (SSOAR), or the UCLA Ethnomusicology Archive.   
 
 
No  
 
x Ye
s 
→ If yes, answer all of the questions below. 
 
a. Describe what will be stored, including whether any direct or indirect (e.g., subject 
codes) identifiers will be stored.  
 
We will bank all unidentifiable data on UW secured computers. A list of potential 
participants who want to participate in future research studies will be stored in a 
password protected file on secured computers along with participant contact 
information and a few screening variables (age, previous phone use, gender, etc- a 
copy of this information is attached with this submission: <future contact for 
research=).  
 
b. Describe what will be shared, including whether direct identifiers will be shared and (for 
specimens) what data will be released with the specimens.  
 
Direct identifiers will not be shared with anyone outside of the research team. 
Unidentifiable data may be shared with the research community.  
 
c. Describe the possible future uses, including limitations or restrictions (if any) on future 
uses or users. As stated above, consider the broadest possible uses. 
 
Examples: data will be used only for cardiovascular research; data will not be used for 
research on population origins. 
 
Potential future uses of de-identified data:  
- 
Data that could inform future interventions 
- 
Recruitment for future studies 
- 
Data to support grant proposals for future research 
 
d. Consent. Will you obtain consent now from subjects for the banking and/or future 
sharing?  
 
 
No 
 
 
x 
Yes → If yes, be sure to include the information about this consent process in 
the consent form (if there is one) and in your answers to the consent 
questions in Section 6. 
 
 
 
e. Withdrawal. Will subjects be able to withdraw their data/specimens from banking or 
sharing?  
 
x No 
 
 
 
Yes 
→ If yes, describe how, and whether there are any limitations on 
withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be 
retrieved after they are released. 
 
      

30 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
f. Agreements for sharing or release. Confirm by checking the box that you will comply 
with UW (and, if applicable, UW Medicine) policies that require a formal agreement 
between you and the recipient for release of data or specimens to individuals or 
entities other than federal databases.   
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer 
Agreements are used for specimens (or specimens plus data. Do not attach your 
template agreement forms; the IRB neither reviews nor approves them 
 
x Confirmed  
5.9 Communication with subjects during the study. Describe the types of communication (if any) you will 
have with already-enrolled subjects during the study. Provide a description instead of the actual 
materials themselves.   
Examples: email, texts, phone, or letter reminders about appointments or about returning study 
materials such as a questionnaire; requests to confirm contact information.  
 
If technical issues are identified or if participants have gone 8dark9 (missing data over a period of time) 
we will provide a text message or call checking in with the participant. Based on their response (i.e. 
express needing technical support, or non-response), an RA will contact the participant to ensure their 
phone is working and to assess if they are still interested in participating. If a participant has gone dark 
for in extended period of time and are unable to be reached by phone, a letter will be sent to their 
mailing address (email or physical mailing address: copy of letter attached). PHI will not be transmitted 
in text messages or emails.  
5.10 Future contact with subjects. Do you plan to retain contact information for your subjects so that they 
can be contacted in the future? 
 
 
No 
 
 
x Yes 
→ If yes, describe the purpose of the future contact, and whether use of the contact 
information will be limited to your team; if not, describe who else could be provided with 
the contact information. Describe your criteria for approving requests for the information. 
 
 
 
Examples: inform subjects about other studies; ask subjects for additional information or 
medical record access that is not currently part of the study proposed in this application; 
obtain another sample. 
 
Future contact would be limited to our research team and would be for the purpose of 
recruitment in new studies our team would be conducting.  
5.11 Alternatives to participation. Are there any alternative procedures or treatments that might be 
advantageous to the subjects? 
If there are no alternative procedures or treatments, select <No=. Examples of advantageous 
alternatives: earning extra class credit in some time-equivalent way other than research participation; 
obtaining supportive care or a standard clinical treatment from a health care provider instead of 
participating in research with an experimental drug.  
 
x No 
 
 
 
Ye
s 
→ If yes, describe the alternatives. 
 
 
 
 

31 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
5.12 Upload to the Supporting Documents SmartForm of Zipline all data collection forms that will be 
directly used by or with the subjects, and any scripts/talking points you will use to collect the data. Do 
not include data collection forms that will be used to abstract data from other sources (such as medical 
or academic records, or video recordings. 
• Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• Translations must be included. However, you may wait to provide them until you know that the IRB 
will approve the English versions, especially if the translations will cost money. 
• For materials that cannot be uploaded: upload screenshots or written descriptions that are 
sufficient to enable the IRB to understand the types of data that will be collected and the nature of 
the experience for the participant. You may also provide URLs (website addresses) or written 
descriptions below. Examples of materials that usually cannot be uploaded: mobile apps; computer-
administered test; licensed and restricted standardized tests. 
• For data that will be gathered in an evolving way: This refers to data collection/questions that are 
not pre-determined but rather are shaped during interactions with participants in response to 
observations and responses made during those interactions. If this applies to your research, provide 
a description of the process by which you will establish the data collection/questions as you interact 
with subjects, how you will document your data collection/questions, the topics you plan to address, 
the most sensitive type of information you will plan to gather, and the limitations (if any) on topics 
you will raise or pursue. 
Use this text box (if desired) to provide short written descriptions of materials that cannot be uploaded, 
such as URLs, and/or a description of the process you will use for data that will be gathered in an 
evolving way. 
 
      
5.13 Send HSD a Confidentiality Agreement if you will obtain or use any private identifiable UW records 
without subject consent (for example, screening medical records or class grades to identify possible 
subjects). 
The Confidentiality Agreement form must be completed, printed, signed, and mailed to the Human 
Subjects Division at Box 359470. Your IRB application cannot be approved until we receive the 
Confidentiality Agreement. 
 
 
6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does your research include minors (children)?     
Minor or child means someone who has not yet attained the legal age for consent for the research 
procedures, as described in the applicable laws of the jurisdiction in which the research will be 
conducted. This may or may not be the same as the definition used by funding agencies such as the 
National Institutes of Health. 
• In Washington State the generic age of consent is 18, meaning that anyone under the age of 
18 is considered a child.  
• There are some procedures for which the age of consent is much lower in Washington State. 
See the WORKSHEET: Children for details.   
• The generic age of consent may be different in other states, and in other countries.  
 
x 
No 
→ If no, go to Section 8. 

32 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
Ye
s 
→ If yes, provide the age range of the minor subjects for this study and the legal age for 
consent in your population(s). If there is more than one answer, explain.   
 
 
 
 
      
 
 
Don’t 
know 
→This means is it not possible to know the age of your subjects. For example, this 
may be true for some research involving social media, the Internet, or a dataset 
that you obtain from another researcher or from a government agency. Go to 
Section 8. 
 
 
6.2 Parental permission. Parental permission means actively obtaining the permission of the parents. This is 
not the same as <passive= or <opt out= permission where it is assumed that parents are allowing their 
children to participate because they have been provided with information about the research and have 
not objected or returned a form indicating they don9t want their children to participate. 
a. Will you obtain parental permission for: 
 
 
All of your research procedures 
→ Go to question 6.2b. 
 
 
 
 
 
 
None of your research procedures 
→ Use the table below to provide your justification, and skip 
question 6.2b. 
 
 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which 
you will not obtain written documentation of consent from 
your adult subjects. <All= is an acceptable answer for some 
studies. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and 
sharing/banking of data and specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which there will be NO parental 
permission 
Reason why you will not 
obtain parental 
permissions 
Will you inform 
them about the 
research?2 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 

33 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across 
the groups and/or procedures. 
2. Will you inform them about the research beforehand even though you are not obtaining active 
permission? 
b. Indicate by checking the appropriate box(es) your plan for obtaining parental permission 
 
 
Both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available; 
or when only one parent has legal responsibility for the care and custody of the child 
 
 
 
 
 
 
One parent, even if the other parent is alive, known, competent, reasonably available, and shares 
legal responsibility for the care and custody of the child.  
 
 
 
 
 
 
This is all that is required for minimal risk research. 
 
If you checked both boxes, explain: 
 
      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, 
or entity? 
 
 
No 
 
 
 
Ye
s 
→ If yes, an advocate must be appointed for each child who is a ward. The advocate must be 
in addition to any other individual acting on behalf of the child as guardian or in loco 
parentis. The same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). Your answer must address the following points: 
• Background and experience 
• Willingness to act in the best interests of the child for the duration of the research 
• Independence of the research, research team, and any guardian organization 
 
      
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
7.1 Assent of children (minors). Though children do not have the legal capacity to <consent= to participate 
in research, they should be involved in the process if they are able to <assent= by having a study 
explained to them and/or by reading a simple form about the study, and then giving their verbal choice 
about whether they want to participate. They may also provide a written assent if they are older. See 
WORKSHEET: Children for circumstances in which a child9s assent may be unnecessary or inappropriate.   

34 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
a. Will you obtain assent for: 
 
 
All of your research procedures and child groups 
→ Go to question 7.2. 
 
 
 
 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then skip to question 7.5. 
 
 
 
 
 
 
Some of your research procedures and child groups 
→ Use the table below to identify the 
procedures for which you will not obtain 
assent. <All= is an acceptable answer for 
some studies. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and 
sharing/banking of data and specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which assent will NOT be obtained 
Reason why you will not obtain assent 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across 
the groups and/or procedures. 
7.2 Assent process. Describe how you will obtain assent, for each child group. If your research involves 
children of different ages, answer separately for each group. If the children are non-English speakers, 
include a description of how you will ensure that they comprehend the information you provide. 
 
      
7.3 Dissent or resistance. Describe how you will identify a child9s objection or resistance to participation 
(including non-verbal indications) during the research, and what you will do in response.  
 
      
7.4 Documentation of assent.  Which of the following statements describes whether you will obtain 
documentation of assent? 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then go to question 7.4.a. 
 
 
 
 
 
 
All of your research procedures and child groups 
→ Go to question 7.4.a, do not complete the 
table 
 
 
 
 
 
 

35 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
Some of your research procedures and/or child 
groups 
→ Complete the table below and then to go 
question 7.4.a 
 
 
Children 
Group1 
Describe the procedures or data/specimen 
collection (if any) for which assent will 
NOT be documented 
Reason why you will not document assent 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across 
the groups and/or procedures. 
 
a. Describe how you will document assent. If the children are functionally illiterate or are not fluent in 
English, include a description of what you will do. 
 
 
      
 
b. Upload all assent materials (talking points, videos, forms, etc.) to the Consent Form and 
Recruitment Materials SmartForm of Zipline. Assent materials are not required to provide all of the 
standard elements of adult consent; the information should be appropriate to the age, population, 
and research procedures.  
7.5 Children who reach the legal age of consent during participation in longitudinal research.  
Children who were enrolled at a young age and continue for many years: It is best practice to re-obtain 
assent (or to obtain it for the first time, if you did not at the beginning of their participation).  
Children who reach the legal age of consent: You must obtain informed consent from the now-adult 
subject for (1) any ongoing interactions or interventions with the subjects, or (2) the continued analysis 
of specimens or data for which the subject9s identify is readily identifiable to the researcher, unless the 
IRB waives this requirement.  
 
a. Describe your plans (if any) to re-obtain assent from children.  
 
      
 
b. Describe your plans (if any) to obtain consent for children who reach the legal age of consent.  
• If you plan to obtain consent, describe what you will do about now-adult subjects whom you are 
unable to contact.   
• If you do not plan to obtain consent or think that you will be unable to do so, explain why.  
 
      
7.6 Other regulatory requirements. (This is for your information only; no answer or response is required.) 
Researchers are responsible for determining whether their research conducted in schools, with student 
records, or over the Internet comply with permission, consent, and inspection requirements of the 
following federal regulations: 
• PPRA – Protection of Pupil Rights Amendment 
• FERPA – Family Education Rights and Privacy Act 

36 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
• COPPA – Children9s Online Privacy Protection Act 
 
 
8 CONSENT OF ADULTS 
Review the following definitions before answering the questions in this section. 
CONSENT 
is the process of informing potential subjects about the research and asking 
them whether they want to participate. It usually (but not always) includes 
an opportunity for subjects to ask questions. It does not necessarily include 
the signing of a consent form. This question is about the consent process. 
CONSENT DOCUMENTATION 
refers to how a subject9s decision to participate in the research is 
documented. This is typically obtained by having the subject sign a consent 
form. 
CONSENT FORM is a document signed by subjects, by which they agree to participate in the 
research as described in the consent form and in the consent process. 
ELEMENTS OF CONSENT are specific information that is required to be provided to subjects. 
PARENTAL PERMISSION 
is the parent9s active permission for the child to participate in the research.  
Parental permission is subject to the same requirements as consent, 
including written documentation of permission and required elements. 
SHORT FORM CONSENT 
is an alternative way of obtaining written documentation of consent that is 
most commonly used with individuals who are illiterate or whose language 
is one for which translated consent forms are not available. 
WAIVER OF CONSENT means there is IRB approval for not obtaining consent or for not including 
some of the elements of consent in the consent process. 
WAIVER OF 
DOCUMENTATION OF 
CONSENT 
means that there is IRB approval for not obtaining written documentation 
of consent. 
8.1 Groups Identify the groups to which your answers in this section apply. 
 
x Adult subjects 
 
 
Parents who are providing permission for their children to participate in research 
 
→ If you selected PARENTS, the word <consent= below should also be interpreted as applying to 
parental permission and <subjects= should also be interpreted as applying to the parents. 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
8.2 The consent process. This series of questions is about whether you will obtain consent for all procedures 
except recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.6. You do not need 
to repeat your answer to question 4.6. 
 
a. Are there any procedures for which you will not obtain consent? 
 
x No 
 
 
 
Yes 
→ If yes, use the table below to identify the procedures for which you will not obtain 
consent. <All= is an acceptable answer for some studies. 
 
 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of 
data and specimens for future work. 
Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which there will be NO 
consent process 
Reason why you will not obtain 
consent 
Will you 
provide them 
with info about 
the research 
after they 
finish? 
 
 
 
YES 
NO 
 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all groups you can collapse your answer across the groups and/or 
procedures. 

38 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
b. Describe the consent process, if you will obtain consent for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• The location/setting where consent will be obtained 
• Who will obtain consent (refer to positions, roles, or titles, not names).  
• Whether/how you will provide an opportunity for questions 
• How you will provide an adequate opportunity for the subjects to consider all options 
 
CMHC staff will describe the study to patient participants and request permission to forward their 
name to research staff or will provide their patient9s with the study URL to express their interest in 
participating and enter eligibility criteria.  
 
Patient Participants: 
A copy of the consent is available on the study website and can either be mailed (email or text) or 
picked up by the participant at their participating site. Research staff will then contact potential 
participants to describe informed consent and limitations to privacy. Participants will be fully 
informed that they are free to stop their participation at any time. Candidates will need to pass a 
brief quiz testing their understanding that participation is completely voluntary. Participants will be 
required to answer questions demonstrating that they understand what type of data will and will not 
be collected from them over the upcoming months (self-report and FOCUS use data). Each question 
will need to be answered correctly before individuals can proceed to provide consent verbally over 
the phone (we request a waiver of written consent).  
 
Staff Participants: 
Eligible staff from participating clinics will be asked to complete a confidential survey online prior to 
their patient starting treatment, then again after their participant completed the intervention 
(roughly 3 months later). 
 
 
We would like to request a waiver for the stamp in order to make the form9s contact information 
modifiable (highlighted text in both consent forms).  
 
Costing Interview Key Informants: 
Key informants will be selected from selected study sites to complete a costing interview via 
videoconferencing. Prior to initiating the audio-recorded interview, key informants will review the 
consent form and provide verbal consent which will be audio-recorded. 
 
c. Comprehension. Describe how you will ensure or test the subjects9 understanding of the information 
during the consent process. 
 
Candidates will need to pass a brief quiz testing their understanding that participation is 
completely voluntary, how long the research study is and what confidentiality means. Participants 
will be required to answer questions demonstrating that they understand what type of data will and 
will not be collected from them.  

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
d. Influence. Does your research involve any subject groups that might find it difficult to say <no= to your 
research because of the setting or their relationship with you, even if you don9t pressure them to 
participate?   
Examples: Student participants being recruited into their teacher9s research; patients being recruited 
into their healthcare provider9s research, study team members who are participants; outpatients 
recruited from an outpatient surgery waiting room just prior to their surgery. 
 
x No 
 
 
 
Yes 
→ If yes, describe what you will do, for each of these subject groups, to reduce any effect 
of the setting or relationship on their decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects9 physician; 
the researcher will not know which subjects agreed to participate; subjects will have 
two days to decide after hearing about the study. 
 
      
e. Ongoing process. For research that involves multiple or continued interaction with subjects over time, 
describe the opportunities (if any) you will give subjects to ask questions or to change their minds 
about participating. 
 
      
8.3 Written documentation of consent. Which of the statements below describe whether you will obtain 
documentation of consent? NOTE: This question does not apply to screening and recruiting procedures 
which have already been addressed in question 4.6. 
Documentation of consent that is obtained electronically is not considered written consent unless it is 
obtained by a method that allows verification of the individual9s signature. In other words, saying <yes= 
by email is rarely considered to be written documentation of consent 
a. Are you obtaining written documentation of consent for: 
 
 
None of your research procedures  → Use the table below to provide your justification then go to 
question 8.4. 
 
x 
 
 
 
 
All of your research procedures  
→ Do not complete the table; go to question 8.3.b. 
 
 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which 
you will not obtain written documentation of consent from 
your adult subjects. <All= is an acceptable answer for some 
studies. 
 
 
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
Adult subject 
group1 
Describe the procedures or 
data/specimen collection (if 
any) for which there will be NO 
documentation of consent 
Reason why you will not obtain 
documentation of consent 
Will you 
provide them 
with info about 
the research 
after they 
finish? 
 
 
 
YES 
NO 
Patient 
Participants 
FOCUS Intervention 
Due to logistical complexities of 
remotely enrolling participants 
across k=20 sites we are requesting 
a waiver to written documentation 
of consent. No trained research 
staff will be on site to obtain written 
documented consent.  
 
 
 
 
 
 
 
 
 
 
x  
 
 
 
 
 
 
Staff 
Participants 
Online assessment 
Written documentation of consent 
will be extremely difficult to obtain 
and due to the low-risk nature of 
the confidential survey, we are 
requesting this waiver. 
 
 
 
 
 
 
 
 
 
 
x  
 
 
 
 
 
 
Staff Key 
Informant 
Interviews 
Interviews regarding costing 
 Interviews will be conducted via 
videoconference. Consent will be 
obtained verbally and recorded. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all adult groups or all procedures, you can collapse your answer across the 
groups and/or procedures. 
 
b. Barriers to written documentation of consent. There are many possible barriers to obtaining written 
documentation of consent. Consider, for example, individuals who are functionally illiterate; do not 
read English well; or have sensory or motor impairments that may impede the ability to read and 
sign a consent form. 
 
b.1 Describe your plans (if any) for obtaining written documentation of consent from potential 
subjects who may have difficulty with the standard documentation process (that is, reading 
and signing a consent form). Skip this question if you are not obtaining written 
documentation of consent for any part of your research.  
 
Examples of solutions: Translated consent forms; use of the Short Form consent process; 
reading the form to the person; excluding individuals who cannot read and understand the 
consent form.   
 
 
We are requesting a waiver for signed documentation of consent for patient and staff 
participants.   

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
8.4 Non-English-speaking or -reading adult subjects. Will you enroll adult subjects who do not speak English 
or who lack fluency or literacy in English? 
 
x 
No 
 
 
 
Ye
s 
→ If yes, describe the process you will use to ensure that the oral and written information 
provided to them during the consent process and throughout the study will be in a 
language readily understandable to them and (for written materials such as consent forms 
or questionnaires) at an appropriate reading/comprehension level. 
 
 
 
      
 
a. Interpretation. Describe how you will provide interpretation and when. Also, describe 
the qualifications of the interpreter(s) – for example, background, experience, language 
proficiency in English and in the other language, certification, other credentials, 
familiarity with the research-related vocabulary in English and the target language.  
 
      
 
b. Translations. Describe how you will obtain translations of all study materials (not just 
consent forms) and how you will ensure that the translations meet the UW IRB9s 
requirement that translated documents will be linguistically accurate, at an appropriate 
reading level for the participant population, and culturally sensitive for the locale in 
which they will be used.  
 
      
8.5 Deception. Will you deliberately withhold information or provide false information to any of the 
subjects? 
 
x No 
 
 
 
Yes 
→ If yes, describe what information and why. 
 
 
Example:  you may wish to deceive subjects about the purpose of the study. 
 
      
 
a. Will you debrief the subjects later? (Note: this is not required.) 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will debrief the subjects. Upload any debriefing 
materials, including talking points or a script, to the Consent Form and 
Recruitment Materials SmartForm of Zipline. 
 
 
 
      
8.6 Cognitively impaired adults, and other adults unable to consent. 
 
a. Target population. Do you plan to intentionally include cognitively impaired adults in your research? 
 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, 
or who are significantly intoxicated. 
 
 
No 
→ If no, go to question 8.8. 
 
x 
Yes 
→ If yes, answer the following questions. 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
a.1. Rationale. Provide your rationale for including this population in your research.  
 
We would like to extend the opportunity to participate to those with legal 
guardians. Previous research we have conducted using this intervention has 
been found to be effective with those with more severe symptoms and the PI 
feels this could be also beneficial for those who fit criteria with legal guardians.  
 
a.2. Capacity for consent / decision making capacity. Describe the process you will use 
to determine whether a cognitively impaired individual is capable of consent 
decision making with respect to your research protocol and setting.  If you will 
have repeated interactions with the impaired subjects over a time period when 
cognitive capacity could increase or diminish, also describe how (if at all) you will 
re-assess decision-making capacity and consent during that time. 
 
 
We will continue to implement our current protocol of providing a competency 
screener, which consists of summarizing the study in their own words (we probe 
about length of study, what the study involves (i.e., smartphone app, calls with 
mHSS, questionnaires), reciting back three content areas the questionnaires will 
cover (health, mood and symptoms), and to define what voluntary participation 
means. Any participant, legal guardian or not, will not be enrolled into the trial if 
they are unable to answer these questions correctly. 
 
a.3. Permission (surrogate consent). If you will include adults who cannot consent for 
themselves, describe your process for obtaining permission (<surrogate consent=) 
from a legally authorized representative (LAR).   
 
For research conducted in Washington State, see the SOP: Legally Authorized 
Representative to learn which individuals meet the state definition of <legally 
authorized representative=. 
 
 
A researcher will make a call to the legal guardian and will outline the study just 
as the current protocol for patient-participants outlines. We will also administer 
the competency screener so we can confirm they understand the basic 
requirements for the study.  
 
a.4. Assent. Describe whether assent will be required of all, some, or none of the 
subjects. If some, indicate which subjects will be required to assent and which will 
not (and why not). Describe any process you will use to obtain and document 
assent from the subjects.  
 
 
A researcher will make a call to the potential participant (with LAR) and will 
outline the study just as the current protocol for patient-participants outlines. 
We will also administer the competency screener so we can confirm they 
understand the basic requirements for the study. 
 
a.5. Dissent or resistance. Describe how you will identify the subject9s objection or 
resistance to participation (including non-verbal) during the research, and what 
you will do in response. 
 
 
      

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
8.7 Consent-related materials. Upload to the Consent Forms and Recruitment Materials SmartForm of 
Zipline all consent scripts/talking points, consent forms, debriefing statements, Information Statements, 
Short Form consent forms, parental permission forms, and any other consent-related materials you will 
use. 
• Translations must be included. However, you are strongly encouraged to wait to provide them until 
you know that the IRB will approve the English versions. 
• Combination forms: It may be appropriate to combine parental permission with consent, if parents 
are subjects as well as providing permission for the participation of their children. Similarly, a 
consent form may be appropriately considered an assent form for older children.  
• For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient 
to enable the IRB to understand the types of data that will be collected and the nature of the 
experience for the participant. You may also provide URLs (website addresses) or written 
descriptions below. Examples of materials that usually cannot be uploaded: mobile apps; computer-
administered test; licensed and restricted standardized tests. 
 
 
9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Is this research likely to leave subjects with a concern that their privacy is being/has 
been invaded? 
Privacy refers to the sense of being in control of access that others have to ourselves. This can be an 
issue with respect to recruiting, consenting, sensitivity of the data being collected, and the method of 
data collection. 
Examples:  
• Many subjects will feel a violation of privacy if they receive a letter asking them to participate in a 
study because they have ____ medical condition, when their name, contact information, and 
medical condition were drawn from medical records without their consent. Example: the IRB 
expects that <cold call= recruitment letters will inform the subject about how their information 
was obtained. 
• Recruiting subjects immediately prior to a sensitive or invasive procedures (e.g., in an outpatient 
surgery waiting room) will feel like an invasion of privacy to some individuals. 
• Asking subjects about sensitive topics (e.g. details about sexual behavior) may feel like an 
invasion of privacy to some individuals. 
 
 
No 
 
 
x Ye
s 
→ If yes, describe the steps you will take, if any, to protect the privacy of subjects and 
potential subjects.  
 
 
 
 
 
Participants may feel uncomfortable answering questions about their symptoms during 
assessments. Participants will be reminded that they are able to skip questions, take a 
break at any time, or let research staff know they no longer want to participate in the 
study. We can connect patient participants to their clinical staff if needed. 
 
 
  

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
9.2 Identification of individuals in publications and presentations. Do you plan to use potentially 
identifiable information about subjects in publications and presentations, or is it possible that individual 
identities could be inferred from what you plan to publish or present?  
 
x No  
 
 
Ye
s 
→ If yes, will you obtain subject consent for this use? 
 
 
Yes 
 
 
 
No 
→ If no, describe the steps you will take to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
      
9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to 
report some kinds of abuse, and medical conditions that are under public health surveillance. These 
include: 
• Child abuse 
• Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• Sexual assault 
• Serious physical assault 
• Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of your research team likely to learn of any of the above events or circumstances 
while conducting your research AND feel obligated to report it to state authorities? 
 
x No 
 
 
 
Ye
s 
→ If yes, the UW IRB expects you to inform subjects of this possibility in the consent form or 
during the consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers. Check the box below to indicate your assurance that you will not destroy any 
identifiers (or links between identifiers and data/specimens) that are part of your research records until 
after the end of the applicable records retention requirements (e.g. Washington State; funding agency or 
sponsor; Food and Drug Administration) for your research. 
See the <Research Data= sections of the following website for UW Records management for the 
Washington State research rectords retention schedules that apply in general to the UW (not involving 
UW Medicine data): 
http://f2.washington.edu/fm/recmgt/retentionschedules/gs/general/uwgsResearch#R  
 
See the <Research Data and Records= information in Section 8 of this document for the retention 
schedules for UW Medicine Records: http://www.uwmedicine.org/about/Documents/UWMRRS-
1.5.pdf 
 
x 
Confirm 
9.5 Certificates of Confidentiality. Do you have or, are you planning to obtain, a federal Certificate of 
Confidentiality for your research data? 
 
x No 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
Ye
s 
 
9.6 Data and specimen security protections. Identify your data classifications and the security protections 
you will provide, referring to the ZIPLINE GUIDANCE: Data and Security Protections for the minimum 
requirements for each data classification level. 
<Risk of harm= refers to the risk of harm that would occur with a breach of the unprotected or breached 
data. 
 
Level 
Data Classification 
 
1 
Very low risk of harm if disclosed 
These data have very little or no sensitivity. Disclosure of these data would have very little 
or no risk of physical, psychological, social, economic, legal, or educational advancement 
harm to the subjects. 
 
Examples: De-identified, anonymous, or publicly available data, data for which subjects 
have consented to allow public access (e.g., a museum archive), opinions of individuals 
about non-sensitive issues or performance on non- sensitive tasks. 
 
2 
Some risk of minor harm to individuals if disclosed 
These data have relatively little sensitivity except possibly short-term embarrassment or 
psychological discomfort if the data were disclosed. 
 
Examples: Performance of individuals on non-sensitive tasks in a competitive situation, 
genetic information about individuals9 metabolism of medical drugs such as statins. 
 
3 
Could cause risk of material harm to individuals if disclosed 
These data could result in harm that can have genuine impact, but the magnitude and/or 
duration are generally not serious, long-lasting, and/or irreversible. 
 
Examples: Non-sensitive Personal Health Information. 
 
4 
Would likely cause serious harm to individuals if disclosed 
These data could result in serious harm, if disclosed. 
 
Examples: Sensitive Personal Health Information, such as the history of cancer or other 
significant conditions which could (for example) affect employability or insurability. 
 
5 
Extremely sensitive; could cause severe harm to individuals if disclosed 
These data could result in serious and long-lasting harm, if disclosed. 
 
Examples: Information about subjects9 illegal behavior, very sensitive Personal Health 
Information such as the diagnosis of HIV/AIDS in some cultures, or a diagnosis of leprosy. 
 
a. Which level of protections will you apply to your data and specimens? If you will use more than one 
level, describe which level will apply to which data and which specimens. 
 
 
3 
 
b. Use this space to provide additional information, details, or to describe protections that do not fit 
into one of the levels. 
 
 
      

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
10 RISK / BENEFIT ASSESSMENT 
10.1 Anticipated risks. Describe the reasonably foreseeable risks of harm, discomforts, and hazards to the 
subjects and others of the research procedures. For each harm, discomfort, or hazard: 
• Describe the magnitude, probability, duration, and/or reversibility of the harm, discomfort, or 
hazard, AND 
• Describe how you will manage or reduce the risks. 
• Consider physical, psychological, social, legal, and economic risks, including risks to financial 
standing, employability, insurability, educational advancement or reputation. 
• Examples of <others=: embryo, fetus, or nursing child; family members; a specific group.  
• Do not include the risks of non-research procedures that are already being performed.  
• If the study design specifies that subjects will be assigned to a specific condition or intervention, then 
the condition or intervention is a research procedure - even if it is a standard of care.  
• Examples of mitigation strategies: inclusion/exclusion criteria; applying appropriate data security 
measures to prevent unauthorized access to individually identifiable data; coding data; taking blood 
samples to monitor something that indicates drug toxicity. 
• As with all questions on this application, you may refer to uploaded documents. 
 
There are minimal risks associated with participation in this study. Any potential risks that might exist 
fall into three categories: (1) risks associated with the intervention; (2) risks associated with research 
assessments (3) risks associated with potential loss of confidentiality. We address each in turn below.  
 
1. Risks of the intervention. mHealth interventions for people with SSD have not been shown to cause 
harm in any of our mHealth studies or in research reported in the published literature. Our extensive 
line of FOCUS research in similar CMHC settings suggests it is a highly acceptable and safe intervention 
in this environment. We have deployed FOCUS for periods ranging five days to seven months and have 
not had any adverse events reported. PI Ben-Zeev is currently conducting a separate smartphone 
intervention study with more high-risk participants who were recently discharged from the hospital as 
part of a relapse prevention program for schizophrenia (R01MH103148). The four-year study is 
concluding in July 2017; participants with SSD have been using a smartphone system (CrossCheck) that 
is deployed for a period that is four times longer than what is proposed for the current study. The 
CrossCheck platform is much more elaborate and technologically complex than the FOCUS intervention 
we propose to use here. Similar to the FOUCS line of research, we have not had any adverse events 
reported. 
 
Participants in FOCUS research choose if/ when to engage. The main risk is engaging in intervention 
content while engaged in other activities that require participants9 full attention (e.g., driving, crossing 
streets, operating machinery or appliances, caring for a child). Participants will be instructed to use the 
smartphone only when it is completely safe to do so. Participants will be socialized to the intervention 
model and advised that research staff and project personnel (i.e., facilitators) will not see their 
intervention use content or messages in any time-sensitive manner and that these forms of 
communication should not be used for an emergency. 
 
2. Risks associated with research assessments. Research assessments include questions about 
functioning, psychiatric symptoms, other emotional or social problems, and illness management and 
recovery skills (patients) as well as evaluation of FOCUS usefulness and assessment of its strengths and 
limitations in the context of CMHC workflow (for staff). Responding to these items may cause 
discomfort or distress in some. CMHC staff may feel apprehensive about offering feedback that may be 
viewed as critical of FOCUS intervention. Individuals may also endorse suicidal ideation when 
completing measures or bring this up during screenings or debriefings. 
 
3. Risks associated with potential loss of confidentiality. Whenever healthcare information is relayed 
outside of the physical clinic it creates new patient privacy and data security challenges. Potential risks 

47 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
include loss, theft, or inadequate disposal of a mobile phone that contains health information, 
unauthorized access to information while it is stored on the device or transmitted (intentionally or 
inadvertently). There is also the remote possibility that research records will be subpoenaed for civil or 
criminal proceedings. All of these potential losses of confidentiality will be disclosed in the informed 
consent documents 
 
4. Risks associated with disclosure of harm to self or others. There is a possibility of participants 
disclosing harmful intentions. If participants disclose suicidal or homicidal intention, research staff will 
probe for more details (i.e. if they have a plan, date, person of interest), and will deliberate with the 
lead PI (a trained clinical psychologist) the level of risk and if there is a need for clinical response. 
Unless there is an overt need for immediate care (i.e., participant said they would immediately hurt 
themselves or others, admitted to overdosing prior to meeting with research staff, etc). If elevation is 
deemed necessary by the research team, a member of the research staff would then reach out to their 
clinical team to proceed with the outlined protocol procedures of the local site (mental health clinic 
serving as a study site). If participants indicate a 1 or higher on Q9 of the PhQ9 Scale (<Thoughts that 
you would be better off dead, or of hurting yourself=), will be sent an email providing additional 
resources (please see 8Email for PHQ99 attachment in this modification).  
 
 
10.2 Unforeseeable risks. Are there any research procedures that may have risks that are currently 
unforeseeable?   
Example: using a drug that hasn9t been used before in this subject population. 
 
x No 
 
 
 
Ye
s 
→ If yes, identify the procedures. 
 
 
 
      
10.3 Subjects who will be under regional or general anesthesiology. Will any research procedures occur 
while subjects-patients are under general or regional anesthesia, or during the 3 hours preceding 
general or regional anesthesia (supplied for non-research reasons)? 
 
x No 
 
 
 
Yes → If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research 
purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be 
removed during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 

48 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If you checked any of the boxes: 
You must provide the name and institutional affiliation of a physician anesthesiologist 
who is a member of your research team or who will serve as a safety consultant about 
the interactions between your research procedures and the general or regional 
anesthesia of the subject-patients. If your procedures will be performed at a UW 
Medicine facility or affiliate, the anesthesiologist must be a UW faculty member.  
 
 
      
 
 
** If you checked the box about radio-isotopes: you are responsible for informing in 
advance all appropriate clinical personnel (e.g., nurses, technicians, 
anesthesiologists, surgeons) about the administration and use of the radio-isotope, 
to ensure that any personal safety issues (e.g., pregnancy) can be appropriately 
addressed. This is a condition of IRB approval. 
10.4 Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as 
defined by NIH), and for studies funded by or involving the Department of Justice. If required for your 
research, upload your DSMP to the Supporting Documents SmartForm in Zipline. If it is embedded in 
another document you are uploading (for example, a Study Protocol, use the text box below to name 
the document that has the DSMP. 
 
We plan to use a Data Safety and Monitoring Board (DSMB) to review problems when reported, and 
then in aggregate for this project on an annual basis.  These procedures will protect the safety of our 
research participants and ensure that our study procedures are not harmful in any way.  Serious, 
unexpected adverse events related to mHealth intervention research participation are very rare in 
studies that are conducted by our group.  The PI, in consultation with co-investigators and others as 
needed, will review Adverse Event reports. They will gather other information to investigate the event 
and determine the need for subsequent action including reporting to the IRB and if determined an 
adverse event by the IRB, will then be reported to the DSMB.   
10.5 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or you do 
not know the group to which the participant is assigned: describe the circumstances under which un-
blinding would be necessary, and to whom the un-blinded information would be provided. 
 
N/A 
10.6 Withdrawal of participants. If applicable, describe the anticipated circumstances under which 
participants will be withdrawn from the research without their consent. Also, describe any procedures 
for orderly withdrawal of a participant, regardless of the reason, including whether it will involve partial 
withdrawal from procedures and any intervention but continued data collection or long-term follow-up. 
 
Participants will be withdrawn if we find they have previously enrolled in the study, used FOCUS or if 
they become unavailable for data collection over the 6 month participation (i.e. hospitalized or 
incarcerated). 

49 
Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
10.7 Anticipated direct benefits to participants. If there are any direct research-related benefits that some 
or all individual participants are likely to experience from taking part in the research, describe them 
below: 
Do not include benefits to society or others, and do not include subject payment (if any). Examples: 
medical benefits such as laboratory tests (if subjects receive the results); psychological resources made 
available to participants; training or education that is provided.  
 
Participants may experience improvement in their illness management, psychosocial functioning, 
reduction in distress associated with psychiatric symptoms, and enhanced recovery. The potential 
benefit to future patients is that the study may provide data on effective implementation methods for 
improving outpatient illness management via mHealth. Community mental health stakeholders may 
benefit from the introduction of a new treatment approach that may improve patient outcomes, 
increase their access to timely and relevant information, and perhaps reduce the burden linked with 
in-person/clinic based care. Considering the minimal risks of the proposed research to outpatient and 
staff participants, and the potential benefit, the benefits of the research seem to far outweigh the 
risks. 
10.8 Individual subjects findings.   
 
a. Is it likely that your research will discover unintentionally discover a previously unknown condition 
such as a disease, suicidal intentions, or genetic predisposition? 
 
 
No 
 
 
x Ye
s 
→ If yes, explain whether and how you would share the information with the subject. 
 
 
 
There is a possibility of participants disclosing harmful intentions. If participants 
disclose suicidal or homicidal intention, research staff will probe for more details (i.e. 
if they have a plan, date, person of interest), and will deliberate with the lead PI (a 
trained clinical psychologist) the level of risk and if there is a need for clinical 
response. Unless there is an overt need for immediate care (i.e., participant said they 
would immediately hurt themselves or others, admitted to overdosing prior to 
meeting with research staff, etc). If elevation is deemed necessary by the research 
team, a member of the research staff would then reach out to their clinical team to 
proceed with the outlined protocol procedures of the local site (mental health clinic 
serving as a study site). If participants indicate a 1 or higher on Q9 of the PhQ9 Scale 
(<Thoughts that you would be better off dead, or of hurting yourself=), will be sent an 
email providing additional resources (please see 8Email for PHQ99 attachment in this 
modification). 
 
 
 
b. Do you plan to routinely share the individual results of your study procedures with the subjects – 
such as genetic test results, laboratory tests, etc.? 
 
x No 
 
 
 
Ye
s 
→ If yes, complete and upload the SUPPLEMENT: Participant Results Sharing to the 
Supporting Documents SmartForm of Zipline 
 
 
10.9 Commercial products or patents. If a commercial product or patent could result from this study, 
describe whether subjects might receive any remuneration/compensation and, if yes, how the amount 
will be determined: 
 
Participants would not receive any compensation if a commercial product or patent were created. This 
is clearly stated in the consent form.  
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
 
11 ECONOMIC BURDEN TO PARTICIPANTS 
11.1 Financial responsibility for research-related injuries. Answer this question only if the lead researcher is 
not a UW student, staff member, or faculty member whose primary paid appointment is at the UW.  
 
Describe who will be financially responsible for research-related injuries experienced by subjects, and 
any limitations. Describe the process (if any) by which participants may obtain 
treatment/compensation.   
 
The lead researcher is a UW faculty member 
11.2 Costs to subjects. Describe any research-related costs for which subjects may be responsible (e.g., CT 
scan required for research eligibility screening; co-pays; cost of a device). 
 
N/A 
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel 
expenses).   
 
N/A 
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following 
information about your faculty advisor.  
• Advisor9s name 
• Your relationship with your advisor (for example: graduate advisor; course instructor) 
• Your plans for communication/consultation with your advisor about progress, problems, and 
changes.  
 
N/A 
12.2 Study team communication. Describe how you will ensure that each study team member is adequately 
trained and informed about the research procedures and requirements (including any changes) as well 
as their research-related duties and functions. 
 
 
There is no study team. 
 
 
 
 
At the beginning of the study the team will meet to discuss the study, deliverables and 
implementation. Printed study protocols will outline study procedures in detail to ensure proper and 
consistent implementation. Trainings will be conducted with study staff to ensure they understand the 
protocols and provide the opportunity to ask questions / give feedback. Weekly team meetings will 
provide opportunities to discuss any changes in procedures or requirements. Audits of study materials, 
trackers and databases will take place monthly or quarterly basis with additional training provided if 
necessary.  
 
 

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Implementing mHealth for Schizophrenia in Community Mental Health Settings 10.15.20 
 
13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Other regulatory approvals. Identify any other regulatory approvals that are required for this research, 
by checking applicable boxes 
Do not attach the approvals unless requested by the IRB.   
 
Approval 
Research for which this is required 
 
 
Radiation Safety 
Procedures involving the use of radioactive materials or an ionizing 
radiation producing machine radiation, if they are conducted for 
research rather than clinical purposes. Approvals need to be 
attached to the Supporting Documents page in Zipline. 
 
 
 
 
 
 
Institutional Biosafety 
Procedures involving the transfer/administration of recombinant 
DNA, DNA/RNA derived from recombinant DNA, or synthetic DNA. 
 
 
 
 
 
 
RDRC 
Procedures involving a radioactive drug or biological product that is 
not approved by the FDA for the research purpose and that is being 
used without an IND, for basic science research (not to determine 
safety and effectiveness, or for immediate therapeutic or diagnostic 
purposes). 
 
 
 
 
 
 
ESCRO 
Procedures involving the use of some types of human embryonic 
stem cells. 
 
 
 
 
13.2 Approvals and permissions. Identify any other approvals or permissions that will be obtained.  For 
example:  from a school, external site/organization, funding agency, employee union, UW Medicine 
clinical unit.   
Do not attach the approvals and permissions unless requested by the IRB. 
 
We received approval from UW Medicine Harborview clinic leadership. 
13.3 Financial Conflict of Interest. Does any member of the team have a Financial Conflict of Interest (FCOI) 
in this research, as defined by UW policy GIM 10?    
 
x No 
 
 
 
Yes → If yes, upload the Conflict Management Plan for every team member who has a FCOI with 
respect to this research, to the Supporting Documents page of Zipline. If it is not yet 
available, use the text box to describe whether the Significant Financial Interest has been 
disclosed already to the UW Office of Research.