Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
Phase: NA
Conditions: Depression
Sponsor: Northwestern University

Evaluating Technology Enabled Services in Perinatal Depression 
NCT05525689 
11.2.23 

STU#:00211815 
Version Date: 10.18.23
Page 1 of 20
HRP-593 / v03152019
PROTOCOL TITLE:  Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to 
Treat Perinatal Depression
SHORT TITLE: Evaluating Technology Enabled Services in COMPASS 
PRINCIPAL INVESTIGATORS:
Emily Miller, MD, MPH
Division Director of Maternal-Fetal Medicine
Women and Infants Hospital
Associate Professor, Department of Obstetrics and Gynecology
Warren Alpert Medical School of Brown University
Women and Infants Health, Care New England
111 Brewster Street, Building B
Pawtucket, RI 02861
David C. Mohr, PhD
Feinberg School of Medicine
Department of Preventive Medicine
312-503-1403
d-mohr@northwestern.edu
VERSION DATE: 10.18.2023
 
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
IND / IDE / HDE # 
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
85
Funding Source
National Institutes of Health
Indicate the type of consent to 
be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related Radiation 
Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
OBJECTIVES
The aim of this study is to test a Technology Enabled Service (TES) to support the treatment of 
depression in the context of a collaborative care service (called COMPASS) in the Northwestern Medical 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 2 of 20
HRP-593 / v03152019
obstetrics clinics. The TES consists of digital technologies that connect patients to Care Managers 
remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital 
intervention. 
We will compare the TES to an eTreatment As Usual (eTAU) consisting of current care plus access to a 
website [http://compass-care.northwestern.edu/] that will provide content specific to perinatal depression. 
We will utilize a randomized clinical trial (RCT) to compare a technology enabled service (TES) 
intervention to enhanced treatment as usual (eTAU) within antenatal and postpartum women. 
Randomization will occur at the patient level. It is not feasible to mask participants or providers.
The primary effectiveness outcome is depression severity. Secondary outcomes are anxiety, and 
satisfaction with care. 
Aims
Aim 1: Conduct a pilot Optimization-Effectiveness-Implementation (OEI) hybrid trial of a Technology 
Enabled Service (TES) for the treatment of depression compared to enhanced treatment as usual 
(eTAU).
Aim 2: Experimental therapeutics aims. Analyses will explore the mediating effects of the CM dashboard 
features that support the CM’s treatment activities and workflow, including tracking symptom response, 
managing the stepped care processes, and communicating care plans. We will also explore the 
moderating effects of race, ethnicity, income, age, anxiety symptom severity, and mobile phone 
competence on the depression outcome. 
BACKGROUND
Note: The “Background” section has been significantly reduced to create a more succinct protocol 
document. The original grant submission with the full background information is available upon request.
1. Perinatal depression is common and associated with adverse maternal and child outcomes.1-5
Glossary of Terms:
a.
Perinatal: relating to the time, usually a number of weeks, immediately before and after birth.
a.
Antenatal: before birth; prenatal.
b.
Postpartum: The period just after delivery, as with postpartum depression. 
Postpartum refers to the mother, and postnatal to the baby.
2. Myriad barriers to effective treatment exist.6-11 
3. Collaborative Care (CC) represents an innovative health systems approach to depression 
treatment.12-20 
4. Perinatal Depression poses unique care challenges.21-22 
5. Significant gaps exist in Perinatal CC implementation.23-26
6. Technology enabled services (TES) may offer a solution for effective Perinatal CC delivery. 
TESs can (a) include dashboards/interfaces to automate Care Manager (CM) tasks and streamline CM 
workflows for population-based case review; (b) connect the CM to both patients and providers, 
facilitating communication about stepped care among the entire care team; and (c) directly deliver digital 
treatments to people who are unable to engage in person due to logistical barriers common in the 
Perinatal period. Smartphones are broadly available among reproductive aged people and are owned by 
94% of Americans under age 30 and 89% ages 31-49.27-29 Several RCTs have shown that digital 
interventions delivered through smartphones are effective in reducing Postpartum Depression.30 As such, 
a TES can integrate a seamless service in which adherence to the core tenets of CC are facilitated by 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 3 of 20
HRP-593 / v03152019
digital technologies, but this novel application of TES has not been previously studied.
STUDY ENDPOINTS
We will utilize a pragmatic, RCT based on our OEI hybrid trial design.53-55 A total of 85 people (75 from 
Northwestern and 10 from Women and Infants Hospital) will be randomized to either TES or enhanced 
treatment as usual (eTAU).  Descriptions of the TES and eTAU interventions appear in the next section 
labeled “Study Intervention(s)/ Investigational Agent(s).”  Depressive symptoms and other outcomes will 
be measured at baseline and at 6 and 12 weeks. Beyond 12 weeks,  participants will be allowed to 
continue use of the TES app and the eTAU website for the duration of the grant-funded budget period. 
App and website use will be tracked for the entire study duration.
STUDY INTERVENTION(S)  / INVESTIGATIONAL AGENT(S)
Participants will be assigned to receive one of two study interventions: (1) a Technology Enabled Service, 
or (2) Enhanced Treatment as Usual. The design of the TES and eTAU interventions were determined 
through the design study (STU# STU00211314) and negotiations with our software development 
contractor (Adaptive Health).
Technology-Enabled Service (TES)
The TES will be based on Adaptive Health’s IntelliCare platform (described below). The TES will permit 
use of text message communication.  Text message content will meet HIPAA standards, and will not 
contain information that might identify the patient as being in treatment for depression. Text message 
communication may be used to encourage IntelliCare app use or arrange phone calls to avoid risk of loss 
of confidentiality.
IntelliCare
The IntelliCare intervention consists of 2 components: (1) a patient-facing app for assessment and self-
management of depression, (2) a Care Manager dashboard. A brief description of each component 
appears below:
1.
Patient-facing app: The patient-facing app contains the following tools for the assessment and 
self-management of depression: 

Assessment: Within the IntelliCare App, participants will be prompted to complete an 
assessment of current (within the prior 2 weeks) depressive and anxiety symptoms.

Self-management: IntelliCare depression and anxiety self-management modules will be used 
in the trial. Each module represents a single behavioral strategy (e.g., scheduling positive 
behaviors, thought restructuring, goal setting), and takes only a few seconds to use. The 
modules address specific treatment goals, and may include instructional content as well as 
interactional components (e.g., activity scheduling/monitoring, thought records) that support 
behavior change. All participants will download the main app onto their own phones and will 
be encouraged to use the modules as directed by the CM throughout the study period.
2.
Care Manager Dashboard: The CM dashboard displays which modules are being used by which 
patients, supporting efficient triage and clinical decision making. The dashboard also includes 
mental health assessment scores, a place to document notes about patient interactions, and a 
text messaging interface.
Enhanced Treatment as Usual (eTAU)
The eTAU will consist of current care plus access to a website (compass-care.northwestern.edu) that will 
provide content specific to perinatal depression.  Patients randomized to eTAU will communicate with 
their Care Managers using phone or MyChart, which is consistent with standard clinical practice.  
PROCEDURES INVOLVED
This is a multi-pronged prospective investigation of a TES to improve collaborative care service delivery 
to people with perinatal depression. Participants will be enrolled in a pragmatic RCT with outcome 
assessments at baseline, 6 and 12 weeks. 
Data will be gathered from study participants as outlined in the table below. We have described how data 
collection methods differ by randomization assignment where applicable.
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 4 of 20
HRP-593 / v03152019
Table 1. Effectiveness Measures
Outcome/Construct
Measure Name
Method
Timing 
Depressive and suicidality 
symptoms 
PHQ-9 with BDI 
TES: data gathered via 
IntelliCare and REDCap
eTAU: data gathered routinely 
for COMPASS clinical care 
CMs or research team will 
enter these data in the study 
database.
Continuous
Anxiety symptoms
GAD-7
TES: data gathered via 
IntelliCare and REDCap
eTAU: data gathered routinely 
for COMPASS clinical care 
CMs or research team will 
enter these data in the study 
database.
Continuous
Suicidal ideation
Columbia Suicide Risk 
Assessment
Data gathered routinely for 
COMPASS clinical care by 
Care Managers or research 
team and entered in the study 
database by the CM or 
research team
As needed
Demographics
Demographics 
Questionnaire
Participant self-report survey
0w
Health status
SF-36 (3 items)
Participant self-report survey
0w
Other mental health 
treatment
“Other Mental Health 
Treatment” 
Questionnaire*
Participant self-report survey
0w, 6w, 12w
Technology engagement, 
usability, usefulness, and 
satisfaction
TWEETS
Participant self-report survey
6w, 12w
Mobile phone competence
Mobile Phone 
Competence
Participant self-report survey
0w
Bond between patient and 
CMs
Working Alliance 
Inventory / Short 
Revised (WAI-SR); 
(BOND ONLY)
Participant self-report survey,
Care Manager data entry
6w, 12w
Supportiveness of CMs
Supportive 
Accountability Inventory
Participant self-report survey
6w, 12w
Satisfaction with services
SIMH
Participant self-report survey
6w, 12w
Coaching user feedback 
survey
TES only: Participant self-
report survey
6w
Coaching user feedback
Coaching user feedback 
interview
TES only: Optional participant 
telephone interview
6w
Usability Interview
Usability Interview
TES only: Optional participant 
telephone interview
2w, 4w, 6w
Alcohol and Substance 
Use
Substance use 
information in the EMR
Medical records
Continuous
Comorbidities
Diagnoses from the 
EMR
Medical records
Continuous
Obstetrics information
Actual delivery date, 
complications in 
pregnancy, gestational 
age at delivery
Medical records
Continuous
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 5 of 20
HRP-593 / v03152019
Adherence
App/website usage, 
communication with CM
TES: app usage and text 
message data gathered by 
IntelliCare and transferred to 
the study team  
eTAU: website usage data 
gathered via website analytics 
tools
Continuous
Execution of Stepped 
Care
Each time the PHQ-9 
score is documented, 
the CM or the research 
team will indicate 
whether the stepped 
care protocol was 
executed in response to 
PHQ-9 total score.
Data gathered routinely for 
COMPASS clinical care. 
CMs will enter these data in 
the study database when 
documenting PHQ-9 scores.
Continuous
Self-report surveys and Care Mzanager data entry forms have been uploaded to the eIRB+ system for 
review. Please see the data handling section for a description of the procedures that will be used to 
obtain data from self-report surveys, interviews, CM data entry, medical record data extraction, IntelliCare 
data, and COMPASS website usage data.
DATA AND SPECIMEN BANKING
Deidentified data will be stored indefinitely for secondary analyses. 
STUDY TIMELINES
Enrollment Timeline
Recruitment for the clinical trial will occur outside the context of usual Care Manager (CM) activities and 
will be managed by the research team with support from the Care Managers (CM). All patients judged as 
meeting perinatal depression or anxiety criteria by the research team who are at least 18 years of age will 
be offered participation and will be screened verbally by the research team and/or Care Managers (CM). 
If participants screen eligible, they will be directed to a digital version of the consent form, as described on 
Pg. 12. The research team will record the results of all recruitment contacts.  We expect to enroll 100 
participants through March 2024.
Timeline of Participant Activities
Active participation will last 12 weeks for each study participant.  Participants will use the study 
interventions during the 12-week period and complete assessments according to the schedule laid out in 
table 2 below:
Table 2. Participant Activities
Method
Week 
0
Week 2
Week 4
Week 6
Mid-
Treatment
Week 12
End of 
Treatment
Self-report Survey
x
x
x
Usability Interview (optional)*
x
x
x
Coaching User Feedback Interview  
(optional)*
x
App and Website Usage
Continuous, unobtrusive
Communication with Care Manager
Continuous, unobtrusive
Medical Record Data
Continuous, unobtrusive
 
* Optional Usability/User-Feedback Interviews (2w, 4w, 6w)
Participants will be informed during the informed consent process that they may be invited to complete 
optional interviews.  All interviews will be conducted by telephone.  At the end of week 1, participants will 
be asked if they would like to provide additional feedback about their experience using the IntelliCare app 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 6 of 20
HRP-593 / v03152019
and working with the study coach via paid interviews.  Participants who express interest in providing 
feedback will be contacted by study staff to schedule the optional interview session(s).  More information 
about the nature and timing of the optional interviews is provided below.
IntelliCare app usability interviews (2w, 4w, 6w)
As we begin enrolling the clinical trial, we will invite the first participants randomized to the TES condition 
to provide feedback on the usefulness and usability of the IntelliCare application.  These optional 
interviews will be administered to approximately 10 participants.  
The app usability interview guide has been uploaded to the eirb+ portal for review.
Coaching user feedback interviews (6w)
All participants randomized to the TES condition will be invited to share additional user feedback about 
their experience working with the Care Manager/coach at the week 6 (mid-treatment) timepoint.  
The coaching user feedback interview guide has been uploaded to the eirb+ portal for review.
The anticipated completion date for primary analyses is March 31st, 2025.
INCLUSION AND EXCLUSION CRITERIA:
Eligibility will be assessed by the research team and Care Managers (CM) via a verbal screening survey. 
The screening survey has been uploaded to the eIRB+ system. All patients ages 18 years or older with a 
smartphone who are referred or eligible to receive COMPASS care management for mental health care 
while pregnant or within 3 months of delivery will be offered study participation.
Inclusion Criteria: US Citizen/Resident (for payment purposes), English speaking, 18 years or older, 
referred to COMPASS for mental health care, currently pregnant and currently parenting or within 3 
months of delivery, has mild to severe perinatal depression (defined as a PHQ-9 screen >5) or moderate 
to severe anxiety (defined as GAD-7 screen > 5), owns a smartphone, has used smartphone in last 7 
days
Exclusion Criteria: Has experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index 
pregnancy)*, has severe suicidality (as defined by the presence of a plan and intent to act on that plan), 
not parenting their child (i.e. adoption, foster care, etc.), anyone not meeting the inclusion criteria 
described above
*If a participant experiences a pregnancy loss during the trial, they will remain in the COMPASS program 
but they will be asked to stop using the app.
VULNERABLE POPULATIONS
This research will not impact the course of the pregnancy or health of the fetus. Our
interview questions and assessments will not ask about the health or viability of the fetus, nor about 
decisions the client must make related to the health or viability of the fetus.
RECRUITMENT METHODS
Recruitment for the clinical trial will occur outside the context of usual Care Manager (CM) activities and 
once a participant is randomized, it will be fit into normal processes of care, to make the results as 
generalizable as possible. Patients may be identified a) during regular CM visits or b) through rosters 
pulled using Electronic Medical Records. All patients judged as being either pregnant or within 3 months 
of delivery who are at least 18 years of age will be given an electronic or verbal description of the study 
by the Care Manager or research team and screened for eligibility.  Some patients may be given a 
flier/sent an email/sent a MyChart message with more information about the study before initiating the 
verbal screening procedure. CMs and the research team will record the results of all recruitment contacts. 
All recruitment advertising materials have been uploaded to the eIRB+ system for review. 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
We will reimburse all trial participants for completing research assessments.  
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 7 of 20
HRP-593 / v03152019
All subjects can earn up to $100 for completing online study assessments. Reimbursement for each 
completed assessment is outlined in table 3 below. 
Table 3. Compensation for Completion of Online Surveys (All Participants)
Method
Week 0
Week 6
Week 12
Total
Self-report Survey
$20
$30
$50
$100
Week 0 will be paid after randomization and welcome call. Week 6 and week 12 will be paid upon survey 
completion. 
Subjects randomized to the TES arm can earn additional compensation if they are interested in 
completing the optional user feedback interviews.  Compensation for each interview completed is outlined 
in table 4 below.
Table 4. Compensation for Completion of Optional Interviews (TES Arm Only)
Method
Week 2
Week 4
Week 6
Total
App Usability Interview
$25
$25
$25
$75
Coaching Feedback 
Interview
$25
$25
Total
$25
$25
$50
$100
Depending on Northwestern University payment guidelines and availability at the time of participation, 
payments to participants will be issued in one of the following ways:

Gift card: The following gift card payment methods are available to participants earning no more 
than $100 per calendar year: 

Amazon.com gift card: Participants will be sent a code via email that will allow them to 
redeem an Amazon.com gift card. Gift Cards may only be redeemed toward the purchase of 
eligible goods and services provided by Amazon.com. Participants must create an account 
with Amazon to use the card. No fees apply to Amazon Gift Cards and the balance will not 
expire. 

PNC Stored Value (Visa) Card: If participants do not have an Amazon account or do not wish 
to be compensated through Amazon, they may request a Stored Value (Visa) Card instead. 
The cards may be virtual or physical as per participant preference.

Check: Participants earning more than $100 per calendar year must be paid by check. Checks 
require a signed W9 form. The check may be mailed to the participant’s address.

Through Northwestern University (NU) Payroll if the participant is an NU employee
Participants will be informed that it will take approximately 2-4 weeks for payment to be processed.  
WITHDRAWAL OF PARTICIPANTS
Patients can discontinue the TES and/or study at any time at their own request, or they may be withdrawn 
at the discretion of the investigator for safety, behavioral or administrative reasons. The reason(s) for 
discontinuation will be documented and may include:
Patient voluntarily withdraws from treatment (follow-up permitted); 
Patient withdraws consent (termination of treatment and follow-up);
Patient is unable to comply with protocol requirements; (termination of treatment and follow-up);
Patient demonstrates disease progression (termination of treatment and follow-up);
Note: Care Managers regularly monitor depressive symptoms as part of routine care. They will 
make a referral for additional mental health treatments as needed. Most patients remain in 
collaborative care as a means to support and coordinate their ongoing mental health care. 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 8 of 20
HRP-593 / v03152019
However, if a patient requires psychiatric hospitalization, a partial hospitalization program (PHP), 
or an intensive outpatient program (IOP), they are taken out of the collaborative care program. 
Aligning with this standard clinical care, study participation will end if a patient requires 
hospitalization, PHP, or IOP care. The study team will continue to utilize the data previously 
collected for analysis purposes. 
Patient experiences a pregnancy loss during the trial (follow-up permitted).
RISKS TO PARTICIPANTS
Potential Risks
The proposed study poses minimal risks. All potential risks associated with participation in this study will 
be disclosed in consent documents. Any potential risks that might exist fall into four categories: (a) risks 
associated with the intervention; (b) risks associated with research assessments, consisting of questions 
about depression, anxiety, and personal functioning, and other mental and emotional problems; (c) risks 
associated with potential loss of confidentiality; and (d) risks of worsening mental or emotional state.  We 
address each in turn below.
Risks of the intervention: TES intervention programs generally have not been shown to cause any harm. 
The primary risk of the intervention is participants being distracted by their mobile phones while engaged 
in activities that demand their complete attention. Participants occasionally try to use mobile apps while 
driving motor vehicles, and therefore will be instructed during the intervention onboarding process to 
never to use the mobile phone while driving. Participants will be made aware of the physical, financial, 
and legal risks associated with using the phone while driving. If the research team becomes aware of a 
participant engaging in this behavior, the PIs will consult to determine the most appropriate way to 
eliminate this risk. 
Risks associated with research assessments: Research assessments include questions about depression 
and other mental and emotional problems. Participants will give voluntary responses to interview 
questions; they are told that they can decline to answer any questions that they choose. The instruments 
and methodologies are well tested and are not known to cause problems or distress on the part of the 
participants. All research interview based assessments are audio-recorded, for the purpose of review to 
ensure quality assurance ratings of assessment performance, including ensuring that patients are 
comfortable with the interview procedures. Audiotapes will be maintained on a secure server with no 
identifying information in the labels for the duration of the funded study, unless other arrangements are 
made. On occasion patients may request that audio files be deleted before the end of the study, in which 
case we will comply.
Risks associated with potential loss of confidentiality. There is a slight risk of loss of confidentiality. While 
communication occurs within Adaptive Health’s secure messaging platform, there is some possibility that 
others may see the participant’s open webpage or smartphone. There is also a small possibility that 
databases may be hacked, even though they are behind secure firewalls. Measures to protect security in 
these instances are described below. Confidentiality may be broken by research staff to ensure the 
patient’s safety if there is an imminent threat to self or others. There is also the remote possibility that 
research records will be subpoenaed by a court of law. All of these potential losses of confidentiality will 
be disclosed in the consent documents.  
Risk of Suicide: The development of suicidal ideation during the study remains the most serious risk. 
However, this risk is inherent in the population and would occur whether or not participants were enrolled 
in the study. It is not believed that this risk, or other adverse outcomes are increased as a function of 
being enrolled in this study.
All potential risks associated with participation in this study will be disclosed in consent documents. All 
patient participants will continue to receive all care through their obstetric and collaborative care providers 
within Northwestern Medicine. Thus, the full range of available treatment options are available to 
participants, including antidepressant medications, psychotherapy, electroconvulsive therapy, or inpatient 
treatment. The benefits of these alternatives are that they are evidence-based, more intensive and 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 9 of 20
HRP-593 / v03152019
specialized. This study imposes no restrictions on the participant in terms the use of other treatments. As 
this is a pragmatic study, all treatments available to the individual in the Northwestern Medicine system 
will remain available during study participation.
Protection Against Risks
Loss of Confidentiality: No data will be collected until staff has completed human subjects training and 
IRB approvals have been obtained. Aside from on the written informed consent, names of participants will 
not appear on any written records, including interview forms, survey forms, and checklists. All research 
data will be electronically recorded and stored in Research Electronic Data Capture (REDCap) tools 
hosted at Northwestern University.  REDCap is a secure, web-based application designed to support data 
capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external sources. 
Data communication between data entry computers and database servers will be encrypted via a VPN 
client. Access to the VPN connection will require user authentication via username and password. 
Firewall software will restrict communication to the database server that is absolutely critical for 
conducting research. The databases and all data entry procedures will be designed to maintain the 
confidentiality of patients enrolled into the study. Numbers will be used to identify all written study 
materials, and no personal identifiers will be on such materials. Hard copy files will be stored in a secure 
double-locked room accessible only to the study team. Audio and video data will be stored on secure 
servers and will only be available for coding by study staff. Adaptive Health, the software vendor involved 
in this project, will follow data security guidelines as specified in the Master Service Agreement between 
Northwestern University and Adaptive Health.  
To reduce the risk of loss of confidentiality through the participant’s device, we will instruct patient 
participants on how to add a PIN to their phone to prevent unwanted access. We will clearly inform the 
patient participants of the risk of data insecurity.
Additionally, Dr. Miller and all members of the research team have been fully trained in research conduct, 
including completing the NIH-required Good Clinical Practice Training. 
Emotional Discomfort: Participants will be informed that their participation in the study is entirely voluntary 
and that they may stop at any time without affecting their access to medical care. Participants will be told 
that they may decline to answer any questions or complete any procedures. 
Plans for Ensuring Safety and Suicide Prevention: The development of suicidal ideation during the study 
remains the most serious risk. Patient safety always takes precedence over study protocol. All suicidality 
procedures are managed directly by the patient’s care management team or through research staff 
including Joshua Santiago, Nathan Winquist, and Shannon Smith. The CMs are licensed clinical social 
workers who have completed Mental Health First Aid trainings and have been trained in suicide risk 
management as part of their regular job duties. CMs are buttressed by the COMPASS psychiatrists, the 
obstetricians, and the Asher Center (see Letter of Support from Dr. Wisner) who are available for clinical 
support. Research staff are trained in suicide risk management as part of their regular job duties. 
Research staff are buttressed by clinical psychologists and are available for clinical support. 
There are a number of pathways through which suicidal risk can be detected.  During the trial phases, 
suicidality is detected through automated PHQ-9 self-report assessments, direct communications with the 
Care Managers via phone or messaging (email, text, etc.), or direct communication with research staff 
during user feedback interviews. In each of these instances, the goal is to rapidly acquire additional 
information that can trigger safety procedures if necessary. When suicidality is expressed by the 
participant directly to the research staff in a usability interview or other direct communication, the research 
staff follows up to conduct a risk assessment based on the Columbia Suicide Severity Rating Scale and 
engage the participant in risk management procedures based on their risk status.
All participants in the trial or pre-enrollment receive automated self-report assessments. If a participant 
rates Question 9 of the Patient Health Questionnaire-9 (i.e., “Over the last 2 weeks, how often have you 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 10 of 20
HRP-593 / v03152019
been bothered by thoughts that you would be better off dead or of hurting yourself in some way”) a 1 or 
higher, a second suicidality question from the Beck Depression Inventory (BDI) is administered that is 
more specific in identifying suicide risk.  Participants who indicate that they would like to kill themselves, 
or would kill themselves are considered “at risk.”  All CMs are notified via an alert in the TES and/or by the 
research team directly via email within one business day. The first CM to receive the notification will call 
the patient for a risk assessment based on the Columbia-Suicide Severity Rating Scale by phone within 
one business day. If an acknowledgement is not made by a CM, a member from the research team or 
clinical supervisor will follow up with the CM. Once acknowledgement is made by the CM, the Columbia-
Suicide Severity Rating Scale is conducted as a routine part of clinical care. For patients who are at 
greater than low risk, the CM takes all necessary actions to ensure the safety of the patient, including 
considering the use of psychiatric hospitalization. If the patient does not respond to contact attempts from 
the CM, the patient’s medical emergency contact, on file for all COMPASS patients, is called to assist in 
contacting the patient.  In the rare event that contact cannot be made, CM’s may contact emergency 
services for a wellness check in accordance with COMPASS procedures. When suicidality is expressed 
by the patient directly to the CM, the CM similarly follows up to conduct an evaluation and perform safety 
procedures. Perinatal psychiatrists are available for consultation with CMs and for follow-up consultation 
with any patient perceived to be at risk. For patients who are not at immediate risk and who do not require 
hospitalization, an outpatient psychiatric evaluation may be coordinated by the CM. A member from the 
research team or the clinical supervisor will follow up if the CM does not within two business days.
We note that these are risks inherent in the population and would occur whether or not they were enrolled 
in the study. We do not believe that the risk of these depressive, suicidal, or other adverse outcomes are 
increased as a function of being enrolled in this study or receiving TES during the trial phases. All 
potential risks associated with participation in this study are disclosed in consent documents.
Limits on Confidentiality of Clinical Information: In accordance with standard of care practices in mental 
health, confidentiality is limited in cases when the participant presents as a danger to themselves or to 
others (e.g., situations of physical abuse, neglect, suicidality). If the participant reports imminent 
suicidality or homicidally during any portion of the trial, they will be hospitalized in the appropriate mental 
health facility with input from the perinatal collaborative care team (either voluntarily or involuntarily).
POTENTIAL BENEFITS TO PARTICIPANTS
There is no direct or immediate benefit to participants from whom data will be collected, although we 
anticipate some participants may receive perinatal depression support through the TES. The participants 
enrolled will receive a modest recognition of their time in accordance with their phase of participation. The 
risks to subjects are minimal in this observational study.
DATA MANAGEMENT AND CONFIDENTIALITY
Below, we describe the data management strategy for the range of data collection methods involved in 
this project. 
Self-Report Surveys (REDCap) 
All participant self-report survey data will be electronically recorded and stored in Research Electronic 
Data Capture (REDCap) tools hosted at Northwestern University.  REDCap is a secure, Web-based 
application designed to support data capture for research studies, providing 1) an intuitive interface for 
validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated 
export procedures for seamless data downloads to common statistical packages; and 4) procedures for 
importing data from external sources. Data communication between data entry computers and database 
servers will be encrypted via a VPN client. Access to the VPN connection will require user authentication 
via username and password. Firewall software will restrict communication to the database server that is 
absolutely critical for conducting research. The databases and all data entry procedures will be designed 
to maintain the confidentiality of patients enrolled into the study. 
Care Manager and Research Team Data Entry 
Care managers and the research team will be trained to routinely enter data from anxiety, depression, 
and suicidality assessments in the REDCap study database.  Care managers will only have access to 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 11 of 20
HRP-593 / v03152019
certain data entry forms in the database, and will not be able to access data from participant self-report 
surveys or interviews. 
Interview Data
Audio recordings of interviews will be stored on the secure FSM ResFiles server. Interview audio files 
may be transcribed by the following NU transcription vendor: GMR Transcription, 
https://www.gmrtranscription.com/
Audio files will be shared with GMR Transcription through the vendor’s proprietary web-based application 
for secure file management. The resulting transcripts will be stored on the secure FSM ResFiles server 
and accessed by study team members for coding purposes.  
Numbers will be used to identify any written study materials, such as interview notes, and no personal 
identifiers will be on such materials. 
TES Intervention Data Gathered by Adaptive Health 
All IntelliCare intervention data will be gathered and securely managed by Adaptive Health during the 
trial.  Per the terms of the Master Service Agreement that is in place between NU and Adaptive Health, at 
the end of the trial, Adaptive Health will transfer study data to the NU team and delete all identifying 
information. Table 5 below includes a description of the data elements that will be handled by Adaptive 
Health.
Table 5. Data Elements Handled by Adaptive Health
IntelliCare 
System 
Component
Data Elements Handled by Vendor
IntelliCare App 
Identifiers (e.g. email address) to generate user login and create a unique ID that will 
then follow each user, app use event data (e.g., number of logins, time spent 
reviewing written information in the app), survey responses (PHQ-9, GAD-7, and 
suicidality assessment questions), and patient-entered information (e.g. journal 
entries). 
IntelliCare Care 
Manager 
Dashboard
Dashboard usage use event data (e.g., number of CM logins, time spent reviewing 
records in the dashboard), CM notes about study participants (including a field to 
document participant names for accurate identification of patients in the dashboard).
Text Message 
Communication 
Phone number used to facilitate sending/receiving text messages between study 
coach and participant, log of messages exchanged between study coach and 
participant
Links to Adaptive Health’s privacy policy and terms and conditions are provided below:
https://www.adaptive-health.com/privacy
https://www.adaptive-health.com/terms
The NU research team will receive routine data exports from Adaptive Health as part of our data quality 
assurance strategy; exports will be received using secure data transfer methods and data from the 
exports may be stored on FSM servers and in NU’s instance of REDCap. 
eTAU Website Use Data 
The study team will use google analytics or a WordPress plugin to track website usage amongst 
participants assigned to the eTAU arm.  We may store email addresses in order to establish user 
accounts that would enable tracking of more granular website usage data (e.g. exactly which pages were 
visited and how long participants spent reviewing each page).  The website is hosted on the NU domain, 
and any plugins used to track usage would be enabled using NU’s instance of WordPress.  Only study 
team members who are granted access to the WordPress site or Google Analytics site will be able to 
access usage data. 
Medical Record Data
The study team will work with an EDW analyst to generate reports containing the following data elements:
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 12 of 20
HRP-593 / v03152019

Clinical Data

Medical history (including obstetric information)

Problem list (which may include things like HIV testing results, substance abuse information, 
and mental health information)

Records about medication or drugs

Mental Health information: mental health diagnoses and assessment information, and 
information about encounters with mental health providers.

Billing Data

Number of minutes billed for care management services during study period 
If we are not able to obtain this information via the EDW, a member of the study team with front end 
NMHC Epic access or backend Epic power user access may extract this information from participants’ 
medical records.
 
Deidentified information will be transferred into a study database. This de-identified information will be 
stored separately from any identifying information. 
Data Analysis Plan
Effectiveness analyses will use intention to treat methods. To compare overall effectiveness,  generalized 
linear mixed models (GLMM) will be used to determine if there are differences in effectiveness between 
individuals receiving TES and eTAU over time. Missing data will be examined for potential non-ignorable 
mechanisms, and will be managed through multiple imputation. Additional covariates will also be included 
to identify any substantive changes in the service, technologies, and/or implementation plan as a result of 
optimization. We will examine moderation of treatment arm by strata (postpartum or antenatal), and 
present results within each strata.
Moderation of TES on effectiveness. We will examine any moderation of the effect of treatment arm on 
depressive symptoms by race, ethnicity, age, health status, substance/alcohol use, mobile phone 
competence, or other mental health treatments, in individual GLM models, by estimating a treatment by 
moderator interaction in predicting end of treatment depression scores adjusting for baseline levels of 
depression.    
Power. Although a pilot study, we provide an estimate of effect that we can detect with 100 randomized 
participants, as well as within strata of 80 and 20. As power calculations for repeated measures involve 
correlations over time which are speculative at this point, we provide effect size estimates for 12 month 
PHQ-9 scores based on an independent t-test. We have 80% power to detect an effect size of 0.58 for 
the entire cohort – a difference in PHQ-9 scores between eTAU and TES of 2.9 assuming a SD of 5; and 
effect sizes of 1.41 and 0.65 in antenatal and postpartum populations, which correspond to differences of 
7.03 and 3.26 on the PHQ-9).  
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS
Data and safety monitoring of participants will be monitored by the Principal Investigator, Dr. Miller, who 
have primary responsibility for monitoring and will do so on a weekly basis during their planned meetings. 
Dr. Miller will regularly review all data and adverse events and will report all serious adverse events to the 
Northwestern University Institutional Review Board Requirements. Second, any reporting of significant 
mental or physical health-related symptoms by the participant to the study team will result in appropriate 
referrals to the participant’s clinician or other appropriate facilities.
The PIs, with the support of the entire research team, will follow procedures outlined under the “Protection 
of Human Subjects” document that will serve as part of the quality control process for data confidentiality. 
The PIs will engage with the study team and case managers on a regular basis to ensure data accuracy 
and protocol adherence. 
To ensure the validity and integrity of study data, the PIs, assisted by the Center statistical team, will 
oversee data management and data checking. Study data are accessible at all times for the PIs, the 
biostatistician, and all relevant Co-Is to review. The biostatistical team and study manager will conduct 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 13 of 20
HRP-593 / v03152019
analyses of accrual, drop-outs, protocol deviations on a monthly basis initially, which may drop to 
quarterly once we are confident that procedures are functioning adequately. 
Dr. Miller will review adverse events (AEs) and serious adverse events (SAEs) individually in real-time 
and in aggregate at each DSMB meeting (not less the annually). They will review the information and 
make judgments on whether the events were study-related and the severity of the adverse event. These 
events will be recorded on an Adverse Event Form. Depending on the consensus of the review, further 
action will be taken to revise the intervention to avoid future events or the study will be stopped if 
significant harm is anticipated. The PIs ensure all protocol deviations, AEs, and SAEs are reported to the 
IRB and the NIMH program officer according to the applicable regulatory requirements.
For this study, the following standard AE definitions are used:
Adverse event:  Any unfavorable and unintended sign or symptom temporally associated with the use of 
digital mental health interventions, regardless of whether it is considered related to intervention.
Serious Adverse Event:  Any AE that results in any of the following outcomes:
o
Death
o
Life-threatening situation 
o
Event requiring inpatient hospitalization or prolongation of existing hospitalization
o
Persistent or significant disability/incapacity
AEs are graded according to the following scale:
o
Mild:  An experience that is transient, and requires no special treatment or intervention.  The 
experience does not generally interfere with usual daily activities.  
o
Moderate:  An experience that is alleviated with simple therapeutic treatments.  The experience 
impacts usual daily activities.
o
Severe:  An experience that requires therapeutic intervention.  The experience interrupts usual 
daily activities. If hospitalization (or prolongation of hospitalization) is required for treatment it 
becomes an SAE.
The study uses the following AE attribution scale:
o
Not related:  The AE is clearly not related to the study procedures (i.e., another cause of the 
event is most plausible and/or a clinically plausible temporal sequence is inconsistent with the 
onset of the event).  
o
Possibly related:  An event that follows a reasonable temporal sequence from the initiation of 
study procedures, but that could readily have been produced by a number of other factors.
o
Related:  The AE is clearly related to the study procedures.  
SAEs and specific treatment-associated AEs are reported to the IRB and NIMH program officer within 24 
hours.
Data Safety Monitoring Board (DSMB)
The DSMB will be chaired by Greg Simon, MD, from Kaiser Permanente, Seattle.  Dr. Simon is a well-
respected mental health researcher.  As chair of the DSMB, Dr. Simon will appoint additional board 
members as needed and will determine the meeting schedule. That said, we expect that the DSMB will 
meet twice in the first year of the trial and once in the final year. The PIs, Ms. Kaiser, and Dr. Kwasny 
(biostatistician) will be present to facilitate the flow of information, however they will not be voting 
members.
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Potential participants will be identified by the CM. Prior to being consented, candidates will receive 
information about the study. Candidates who decline the consent procedure or who are screened out will 
have any identifying information removed from study records. Consent for the study will then be managed 
by research study personnel, rather than the CM. The study team will not release the identity of any 
participant to any non-authorized individual, except as is necessary for participant safety or regulatory 
review. 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 14 of 20
HRP-593 / v03152019
ECONOMIC BURDEN TO PARTICIPANTS
There will be no cost to participants to receive the TES.  It is possible that some participants might have 
very limited data plans, and the use of IntelliCare apps will cause them to exceed their data limit resulting 
in fees. IntelliCare apps do not use unusually large amounts of data, so this is an unlikely occurrence, and 
the study team asks about participant data plans and will inform participants of the expected data usage 
prior to downloading the apps. There are no procedures that will be billed to insurance. 
CONSENT PROCESS
Participants who are referred to the trial by their Care Manager will be verbally screened for eligibility.  If 
participants screen eligible, they will be directed to a digital version of the consent form. The consent form 
will be administered via Northwestern University’s instance of REDCap. Subjects will read through the 
consent form, answer a series of questions to assess comprehension, and agree to participate by 
checking a box, typing in their name, and signing electronically. Once the consent is submitted, study 
staff will review the participant’s digital file to ensure that the consent form was signed and the 
comprehension questions were answered correctly. If a participant answers any of the consent 
comprehension questions incorrectly, a research assistant will follow up to review that section of the 
consent form and explain the correct answer. After the consent process is finalized, the participant will be 
able to access a link to complete the baseline self-report measures along with Instructions for 
downloading the IntelliCare applications.
NON-ENGLISH SPEAKING PARTICIPANTS
Non-English speaking participants will not be enrolled. 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
HIPAA authorization language has been included in the study consent form.
The following PHI may be gathered from the patient’s medical record:

Medical history

Problem list (which may include things like HIV testing results, substance abuse information, 
and mental health information).

Records about medication or drugs

Mental Health information: mental health diagnoses and assessment information, and 
information about encounters with mental health providers.

Obstetrics info
Any data that is gathered through the patient’s electronic medical records (EMR) will be deidentified. We 
will store the EMR data separate from the self-report data with identifiers. 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
The research staff at CBITs have extensive experience conducting remote-delivered mental health 
interventions. Dr. Miller has experience with successful recruiting and retaining perinatal individuals in 
longitudinal research studies. With 90 perinatal individuals with PPD currently engaged in COMPASS 
care along with 30-50 patients referred to COMPASS monthly (conservatively 30% of whom have a 
primary diagnosis of PPD), successful recruitment into the pilot randomized trial is highly feasible. The 
COMPASS and CBITs staff have been working closely on the development of this project for several 
months, and are working to put the resources in place to conduct this study. The services being provided 
in this study are a supplement to standard care, and the CM will continue to provide all standard care 
services to patients who enroll in this study.
MULTI-SITE RESEARCH
 Table 6. Research Sites and Vendors
Site
Role
Approvals
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 15 of 20
HRP-593 / v03152019
Northwestern 
University (NU)
NU will serve as the lead site for this study.  Study 
team members will be responsible for maintaining 
current versions of the protocol, consent documents, 
and other IRB materials. NU study team members 
will be responsible for screening and consenting 
study participants, collecting outcome data, 
delivering and supervising the TES, disbursing 
subject payments, managing suicidality 
assessments, and analyzing study data. NU staff will 
facilitate regular project meetings with participating 
sites and will be responsible for communicating 
procedural changes, emergent issues, interim 
results, and study status updates.   NU will be 
responsible for ensuring that all sites involved in data 
handling have executed the appropriate agreements.
IRB protocol number STU00211815
Adaptive Health
Software Development/Maintenance: Adaptive  
Health established a Master Service Agreement with 
Northwestern University to make their IntelliCare 
platform available for use in delivery of the TES. 
Data Storage/Retention:  Adaptive will store data on 
their secure servers during the trial and transfer it to 
NU at the end of the trial. Upon termination of the 
study, Adaptive Health will erase participant 
identifiers and retain only de-identified data which will 
be used to improve the IntelliCare product (per 
section 19 of the Master Service Agreement). 
The following executed agreement 
between NU and Adaptive Health 
has been uploaded to the eirb+ 
portal:
Northwestern University and 
Adaptive Health Master Services 
Agreement_Fully_Executed.pdf
Women and 
Infants Hospital 
(WIH)
Dr. Emily Miller is moving from Northwestern 
University to Women and Infants Hospital (WIH) on 
6/8/22. Dr. Miller will retain her role as primary 
investigator at Women and Infants Hospital. 
Dr. Emily Miller has a faculty appointment at Brown 
University. However, her research is happening at 
WIH, thus this protocol reflects work that is being 
done at WIH.
One institution will act as external collaborating site: 
Women and Infants Hospital. Northwestern 
University will serve as the IRB of Record for each 
relying site. 
Site: Women and Infants Hospital
Site PI: Emily Miller, MD, MPH
Address: 
Women and Infants Hospital -- Care New England
111 Brewster Street, Building B
Pawtucket, RI 02861
Activities to be performing: full research protocol as 
listed in this protocol.  
Of note: No activities will occur at an external site 
until they obtain approval from their local IRB, or the 
NU IRB and external sites fully execute (complete 
and sign) a reliance agreement. External study 
12/19/2022: The study team 
received consultation from the IRB. 
The single IRB letter of support 
states Brown University, but it was 
clarified during the consultation that 
all research activities would take 
place at Women and Infants 
Hospital. The IRB has noted this in 
their files. 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 16 of 20
HRP-593 / v03152019
teams will obtain sign-offs or permissions per their 
local policies. We will provide IRB approval letters 
from external sites, documentation that IRB review at 
external sites is unnecessary, or fully executed 
reliance agreements when available with 
accompanying protocol updates via modification 
requests in eIRB+. We will report non-compliance 
with the study protocol or applicable requirements 
per local policy.

Is reliance mandated per federal guidelines 
or sponsor requirements?
o
Federal guidelines. 

If this research is federally funded, who is the 
prime awardee?
o
Women’s and Infant Health is the 
prime awardee. 

Who is the proposed IRB of Record for all 
participating sites?
o
Northwestern University.

What type of reliance agreement will be 
used?
o
IRB Authorization Agreement (IAA) 

When will institutions or individuals be 
onboarded? When NU is the proposed IRB 
of Record, we prefer to review the NU site 
and overall study scope first, and onboard 
institutions or individuals in subsequent 
modifications via fully executed reliance 
agreements. Onboarding during the initial 
review process may delay initial approval.
o
Institutions will be onboarded after 
this modification is approved. This 
IRB was initially an approved single-
site trial; then, a PI left to another 
institution (WIH) which is why this is 
now a multisite study. 

How will you communicate IRB approval of 
modifications to study procedures to relying 
institutions or individuals, and ensure 
approval before implementation? 
o
Joshua Santiago, Project Manager, 
will be updating relying sites directly. 
He has direct access to each relying 
site IRB system. 

How will you keep participating institutions or 
individuals abreast of any problems, interim 
results, or the eventual closure of the study?
o
Joshua Santiago, Project Manager, 
will be the project manager for the 
relying site and will oversee all 
research activities; thus, he will be 
the one providing updates as 
needed. 

How will you manage information to protect 
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 17 of 20
HRP-593 / v03152019
participants? All institutions and individuals 
must safeguard data, including the secure 
transmission of data, as required by 
applicable local information security policies, 
state laws, and federal regulations.
o
All participant data will be stored in 
Northwestern University REDCap 
and research systems. 
REFERENCES
1.
Gaynes BN, Gavin N, Meltzer-Brody S, et al. Perinatal depression: prevalence, screening 
accuracy, and screening outcomes. Evidence report/technology assessment. 2005(119):1-8.
2.
Wisner KL, Sit DK, McShea MC, et al. Onset timing, thoughts of self-harm, and diagnoses in 
postpartum women with screen-positive depression findings. JAMA psychiatry. 2013;70(5):490-
498.
3.
Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths 
From Suicide and Overdose in Colorado, 2004-2012. Obstetrics and gynecology. 
2016;128(6):1233-1240.
4.
Shakespeare J, Knight M. Maternal health in pregnancy: messages from the 2014 UK 
Confidential Enquiry into Maternal Death. Br J Gen Pract. 2015;65(638):444-445.
5.
Stein A, Pearson RM, Goodman SH, et al. Effects of perinatal mental disorders on the fetus and 
child. Lancet. 2014;384(9956):1800-1819.
6.
The American College of Obstetricians and Gynecologists Committee Opinion no. 630. Screening 
for perinatal depression. Obstetrics and gynecology. 2015;125(5):1268-1271.
7.
LaRocco-Cockburn A, Melville J, Bell M, Katon W. Depression screening attitudes and practices 
among obstetrician-gynecologists. Obstetrics and gynecology. 2003;101(5 Pt 1):892-898.
8.
Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health 
referral among pregnant and postpartum women with psychiatric distress. General hospital 
psychiatry. 2009;31(2):155-162.
9.
Kozhimannil KB, Trinacty CM, Busch AB, Huskamp HA, Adams AS. Racial and ethnic disparities 
in postpartum depression care among low-income women. Psychiatric services. 2011;62(6):619-
625.
10.
Louis JM, Menard MK, Gee RE. Racial and ethnic disparities in maternal morbidity and mortality. 
Obstetrics and gynecology. 2015;125(3):690-694.
11.
Jain JA, Temming LA, D'Alton ME, et al. SMFM Special Report: Putting the "M" back in MFM: 
Reducing racial and ethnic disparities in maternal morbidity and mortality: A call to action. 
American journal of obstetrics and gynecology. 2018;218(2):B9-b17.
12.
Huffman JC, Niazi SK, Rundell JR, Sharpe M, Katon WJ. Essential articles on collaborative care 
models for the treatment of psychiatric disorders in medical settings: a publication by the 
academy of psychosomatic medicine research and evidence-based practice committee. 
Psychosomatics. 2014;55(2):109-122.
13.
Archer J, Bower P, Gilbody S, et al. Collaborative care for depression and anxiety problems. The 
Cochrane database of systematic reviews. 2012;10:CD006525.
14.
Thota AB, Sipe TA, Byard GJ, et al. Collaborative care to improve the management of depressive 
disorders: a community guide systematic review and meta-analysis. American journal of 
preventive medicine. 2012;42(5):525-538.
15.
Grypma L, Haverkamp R, Little S, Unutzer J. Taking an evidence-based model of depression 
care from research to practice: making lemonade out of depression. General hospital psychiatry. 
2006;28(2):101-107.
16.
Reiss-Brennan B, Briot PC, Savitz LA, Cannon W, Staheli R. Cost and quality impact of 
Intermountain's mental health integration program. J Healthc Manag. 2010;55(2):97-113; 
discussion 113-114.
17.
Solberg LI, Glasgow RE, Unutzer J, et al. Partnership research: a practical trial design for 
evaluation of a natural experiment to improve depression care. Med Care. 2010;48(7):576-582.
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 18 of 20
HRP-593 / v03152019
18.
Zivin K, Pfeiffer PN, Szymanski BR, et al. Initiation of Primary Care-Mental Health Integration 
programs in the VA Health System: associations with psychiatric diagnoses in primary care. Med 
Care. 2010;48(9):843-851.
19.
Angstman KB, Phelan S, Myszkowski MR, et al. Minority Primary Care Patients With Depression: 
Outcome Disparities Improve With Collaborative Care Management. Med Care. 2015;53(1):32-
37.
20.
Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health disparities 
research within the health care system: a conceptual framework. Am J Public Health. 
2006;96(12):2113-2121.
21.
Bowen A, Bowen R, Butt P, Rahman K, Muhajarine N. Patterns of depression and treatment in 
pregnant and postpartum women. Canadian journal of psychiatry Revue canadienne de 
psychiatrie. 2012;57(3):161-167.
22.
Button S, Thornton A, Lee S, Shakespeare J, Ayers S. Seeking help for perinatal psychological 
distress: a meta-synthesis of women's experiences. Br J Gen Pract. 2017;67(663):e692-e699.
23.
Grote NK, Katon WJ, Russo JE, et al. Collaborative Care for Perinatal Depression in 
Socioeconomically Disadvantaged Women: A Randomized Trial. Depression and anxiety. 
2015;32(11):821-834.
24.
Melville JL, Reed SD, Russo J, et al. Improving care for depression in obstetrics and gynecology: 
a randomized controlled trial. Obstetrics and gynecology. 2014;123(6):1237-1246.
25.
Solberg LI, Crain AL, Jaeckels N, et al. The DIAMOND initiative: implementing collaborative care 
for depression in 75 primary care clinics. Implement Sci. 2013;8:135.
26.
Solberg LI, Crain AL, Maciosek MV, et al. A stepped-wedge evaluation of an initiative to spread 
the collaborative care model for depression in primary care. Ann Fam Med. 2015;13(5):412-420.
27.
Perrin A, Duggan M. Americans’ internet access: 2000–2015. Pew Research Center. 2015;26.
28.
Smith A. U.S. Smartphone Use in 2015. Pew Research Center: Internet, Science & Tech2015.
29.
Poushter J. Smartphone Ownership and Internet Usage Continues to Climb in Emerging 
Economies. [URL Removed per NIH guidelines].
30.
Lau Y, Htun TP, Wong SN, Tam WSW, Klainin-Yobas P. Therapist-Supported Internet-Based 
Cognitive Behavior Therapy for Stress, Anxiety, and Depressive Symptoms Among Postpartum 
Women: A Systematic Review and Meta-Analysis. J Med Internet Res. 2017;19(4):e138.
31.
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: 
the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health 
Questionnaire. JAMA : the journal of the American Medical Association. 1999;282(18):1737-1744.
32.
Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? 
Eff Clin Pract. 1998;1(1):2-4.
33.
Mohr DC, Tomasino KN, Lattie EG, et al. IntelliCare: An Eclectic, Skills-Based App Suite for the 
Treatment of Depression and Anxiety. J Med Internet Res. 2017;19(1):e10.
34.
Oulasvirta A, Tamminen S, Roto V, Kuorelahti J. Interaction in 4-Second Bursts: The Fragmented 
Nature of Attentional Resources in Mobile HCI. Paper presented at: SIGCHI Conference on 
Human Factors in Computing Systems2005; Portland, Oregon, USA.
35.
Vaish R, Wyngarden K, Chen J, Cheung B, Bernstein MS. Twitch Crowdsourcing: Crowd 
Contributions in Short Bursts of Time. SIGCHI Conference on Human Factors in Computing 
Systems; 2014; Toronto, ON, Canada.
36.
Institute of Medicine (IOM). Psychosocial Interventions for Mental and Substance Use Disorders: 
A Framework for Establishing Evidence-Based Standards. Washington DC: Institute of 
Medicine;2015.
37.
Lattie EG, Schueller SM, Sargent E, et al. Uptake and Usage of IntelliCare: A Publicly Available 
Suite of Mental Health and Well-Being Apps. Internet Interv. 2016;4(2):152-158.
38.
Noth KN, Bardsley L, Lattie EG, Mohr DC. IntelliCare Study Coaching Manual. In: Chicago, IL: 
Northwestern University; 2018: [URL Removed per NIH guidelines].
39.
Corden ME, Koucky EM, Brenner C, et al. MedLink: A mobile intervention to improve medication 
adherence and processes of care for treatment of depression in general medicine. Digital Health. 
2016;2:1-10.
40.
Mohr DC, Stiles-Shields C, Brenner C, et al. MedLink: A Mobile Intervention to Address Failure 
Points in the Treatment of Depression in General Medicine. Int Conf Pervasive Comput Technol 
Healthc. 2015;2015:100-107.
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 19 of 20
HRP-593 / v03152019
41.
Tentori M, Hayes GR, Reddy M. Pervasive Computing for Hospital, Chronic, and Preventive 
Care. Found Trends Hum-Comput Interact. 2012;5(1):1-95.
42.
Reddy MC, McDonald DW, Pratt W, Shabot MM. Technology, work, and information flows: 
lessons from the implementation of a wireless alert pager system. J of Biomedical Informatics. 
2005;38(3):229-238.
43.
Reddy M, Shabot M, Bradner E. Evaluating Collaborative Features of Critical Care Systems: a 
methodological study of information technology in surgical intensive care units. Journal of 
biomedical informatics. 2008;41:479-487.
44.
Reddy M, Pratt W, Dourish P, Shabot MM. Sociotechnical Requirements Analysis for Clinical 
Systems. Methods of Information in Medicine; 2003.
45.
Reddy M, Purao S, Kelly M. Developing IT Infrastructure for Rural Hospitals: a case study of 
benefits and challenges of hospital-to-hospital partnerships. J Am Med Inform Assoc. 
2008;15(554-558).
46.
Wallerstein N, Duran B. Community-based participatory research contributions to intervention 
research: the intersection of science and practice to improve health equity. Am J Public Health. 
2010;100(S1):S40-S46.
47.
Hill S. Balancing iterative design and planning for mobile games. 2015; [URL Removed per NIH 
guidelines]. Accessed Sept. 26, 2016.
48.
Nielsen J. Iterative user-interface design. Computer. 1993;26(11):32-41.
49.
Koo C CN, Kim HW. Examining explorative and exploitative uses of smartphones: a user 
competence perspective. Inform Technol Peopl. 2015;28(1):133-162.
50.
Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-
7.
51.
Faulkner L. Beyond the five-user assumption: Benefits of increased sample sizes in usability 
testing. Behavior Research Methods, Instruments, & Computers. 2003;35(3):379-383.
52.
Nielsen J. Severity ratings for usability problems. Papers and Essays. 1995;54.
53.
Brown CH, Ten Have TR, Jo B, et al. Adaptive designs for randomized trials in public health. 
Annu Rev Public Health. 2009;30:1-25.
54.
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res 
Methodol. 2006;6:54.
55.
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. 
Contemp Clin Trials. 2007;28(2):182-191.
56.
Tomasino KN, Lattie EG, Ho J, Palac HL, Kaiser SM, Mohr DC. Harnessing Peer Support in an 
Online Intervention for Older Adults with Depression. Am J Geriatr Psychiatry. 2017;25(10):1109-
1119.
57.
Lattie EG, Ho J, Sargent E, et al. Teens engaged in collaborative health: The feasibility and 
acceptability of an online skill-building intervention for adolescents at risk for depression. Internet 
Interventions. 2017;8:15-26.
58.
Mohr DC, Duffecy J, Jin L, et al. Multimodal e-mental health treatment for depression: a feasibility 
trial. J Med Internet Res. 2010;12(5):e48.
59.
Burns MN, Begale M, Duffecy J, et al. Harnessing context sensing to develop a mobile 
intervention for depression. J Med Internet Res. 2011;13(3):e55.
60.
Strohbach A, Hu F, Martinez NG, Yee LM. Evaluating the use of text message communication in 
a postpartum patient navigation program for publicly insured women. Patient education and 
counseling. 2018.
61.
Kroenke K, Unutzer J. Closing the False Divide: Sustainable Approaches to Integrating Mental 
Health Services into Primary Care. Journal of general internal medicine. 2017;32(4):404-410.
62.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety 
disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-1097.
63.
Joiner TE, Jr., Pfaff JJ, Acres JG. A brief screening tool for suicidal symptoms in adolescents and 
young adults in general health settings: reliability and validity data from the Australian National 
General Practice Youth Suicide Prevention Project. Behaviour research and therapy. 
2002;40(4):471-481.
64.
Janssen MF, Birnie E, Haagsma JA, Bonsel GJ. Comparing the standard EQ-5D three-level 
system with a five-level version. Value Health. 2008;11(2):275-284.
65.
Lund AM. Measuring usability with the USE Questionnaire. STC Usability Newsletter. 2001;8(2).
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023

STU#:00211815 
Version Date: 10.18.23
Page 20 of 20
HRP-593 / v03152019
66.
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implement Sci. 2017;12(1):108.
67.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and 
correlations with service utilization and psychotherapy outcome. Eval Program Plann. 
1982;5(3):233-237.
68.
Jenkinson C, Layte R, Jenkinson D, et al. A shorter form health survey: can the SF-12 replicate 
results from the SF-36 in longitudinal studies? J Public Health Med. 1997;19(2):179-186.
69.
Saunders JB, Aasland OG, Babor TF, Delafuente JR, Grant M. Development of the Alcohol-Use 
Disorders Identification Test (Audit) - Who Collaborative Project on Early Detection of Persons 
with Harmful Alcohol-Consumption .2. Addiction. 1993;88(6):791-804.
70.
Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders 
Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish 
population sample. Eur Addict Res. 2005;11(1):22-31.
71.
Noth KN BL, Lattie EG, Mohr DC. IntelliCare Study Coaching Manual. 2018; [URL Removed per 
NIH guidelines]. Accessed May 6, 2018.
72.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J 
Gen Intern Med. 2001;16(9):606-613.
73.
Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual 
distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 
2011;38(2):65-76.
74.
Johnson CM, Johnson TR, Zhang J. A user-centered framework for redesigning health care 
interfaces. Journal of biomedical informatics. 2005;38(1):75-87.
75.
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster 
randomised trial: rationale, design, analysis, and reporting. Bmj. 2015;350:h391.
76.
Poots AJ, Woodcock T. Statistical process control for data without inherent order. BMC medical 
informatics and decision making. 2012;12:86.
77.
Benneyan JC, Lloyd RC, Plsek PE. Statistical process control as a tool for research and 
healthcare improvement. Qual Saf Health Care. 2003;12(6):458-464.
78.
Wheeler DJ. Understanding statistical process control, 3rd edition. Knoxville, Tennessee: SPC 
Press; 2010.
79.
Fritz MS, Mackinnon DP. Required sample size to detect the mediated effect. Psychological 
science. 2007;18(3):233-239.
IRB #: STU00211815-MOD0017 Approved by NU IRB for use on or after 11/2/2023