A Text Messaging Intervention to Reduce Perinatal Depression Risk
Phase: NA
Conditions: Major Depressive Episode
Sponsor: University of Massachusetts, Worcester

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Development of a Text Intervention for Perinatal Depression 
 
 
 
 
 
NCS Number pending 
Revised 12/15/2022 
 
 

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1. TITLE 
Development of a Text Intervention for Perinatal Depression 
 
NCS Number pending 
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
 
Conflict of Interest (COI):   
All research staff with a COI to report have completed the necessary disclosure processes.  
 
4. OBJECTIVES* 
Aim 1:  Draw upon the literature and a User Centered Design approach to collect data from 
content area experts, caregivers, and individuals with lived experience of perinatal depression, to 
iteratively develop the Text4Moms tool (tailored text messages, video content, and peer 
navigator dashboard).  
 
Aim 2:  Evaluate preliminary effect direction and magnitude of Text4Moms in a pilot 
randomized trial (Text4Moms vs educational texts; ratio 2:1) with 30 at-risk pregnant individuals 
not in an MDE. Compared to participants randomized to the control condition, those in 
Text4Moms will: H1: show target engagement through improvement in “self-efficacy” of ≥ d = 
0.2 that can protect against development of an MDE; H2: show greater decline in Edinburgh 
Postnatal Depression Scale (EPDS) scores of ≥ d = 0.2, and items indicative of RDOC constructs 
of “loss” and “threat.”1   
 
Aim 3: Examine implementation outcomes by evaluating the usage, acceptability, and feasibility 
of Text4Moms and its components: H3: Participant ratings will average at least 68 on the 
System Usability Scale for the Text4Moms system and components. H4: >70% of patients will 
show engagement in Text4Moms by opening >80% of text messages and clicking on >30% of 
links to enhanced content. H5: >30% of mothers will engage with the chat and endorse 4 out of 5 
on its utility. 
 
5. BACKGROUND* 
5.A.1 Significance 
Perinatal depression is common, impairing, and preventable. In the United States, ~14% of 
pregnant individuals experience an incident major or minor depressive episode, with a similar 
rate occurring postnatally.2,3 Depressive disorders always carry a high personal toll. However, 
during this pivotal time, depression is associated with risk of preterm birth4; can negatively affect 
the dyad through impaired maternal-child attachment5-7; can adversely affect infant 
development8; and decrease breastfeeding initiation/duration.9,10 Federal agencies and provider 
organizations emphasize the need to screen individuals for depression in pregnancy and after 
delivery.11,12 Additionally, the US Preventative Services Task Force (USPSTF) showed 
compelling evidence that counseling strategies can be deployed to prevent perinatal depression 
(pooled risk reduction (RR)=0.61 [95% CI, 0.47 to 0.78], k=17, n=3094, I2=39%).13 
 

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At risk individuals benefit the most from preventative interventions although at-risk 
determinations vary in the literature. While the USPSTF reviewed preventative strategies for 
both individuals considered “at risk” and those not necessarily at risk, high risk groups show the 
greatest reduction in depressive symptoms after engagement in an intervention (RR=0.55; 95% 
CI, 0.44 to 0.68).13 A number of factors constitute risk including a past history of depression, 
especially perinatal depression14-18; genetic factors19-21; history of sexual abuse, early childhood 
abuse and intimate partner violence22,23; stress and poor social support14,18,24-26; low 
socioeconomic status14; undesired pregnancy27; perinatal complications28; certain demographic 
characteristics such as adolescence26 and extant subsyndromal depressive symptoms.29,30 
Measures designed to predict who will become depressed31-33 do not perform substantially better 
than questionnaires that include demographic items and query current symptoms, most likely 
because of collinearity among domains.34,35 On the other hand, screening for existing depression 
is successful. A variety of approaches are used including screening and mood monitoring via 
mobile applications and text messaging.36-39 Systems most commonly use the Edinburgh 
Postnatal Depression Scale (EPDS)38,39 and the Patient Health Questionnaire-9 (PHQ-9)36,37 as 
screeners. The acceptability of tech-based screeners is high.37,38 
 
The most commonly used criteria to identify high risk individuals for participation in prevention 
trials was presence of depressive symptoms not meeting syndromal criteria. Although different 
questionnaires were employed in the various studies, the most frequent was the EPDS at a 
threshold score of 9.40-44 Several successful studies also included individuals with a history of 
depression as at high risk.45-48 This tracks with the strong signal in the literature placing this 
group at high likelihood of depression relapse. 
 
Research Domain Criteria (RDOC) provide utility to further explore mechanisms related 
to preventative interventions. RDOC offers a model to understand and further explore the 
neurobiological systems involved in perinatal depression.49 Depression falls into the negative 
valence domain with features of loss and threat (anxiety/fear).50 Depression also falls within the 
postive valence system with (lack of) reward responding, i.e. anhedonia.1,50-52 An empiric study 
supported the notion that among perinatal individuals, the systems placing them at risk include 
the negative valence domains such as threat (anxiety/fear) and loss.53 Indeed, these systems fit in 
well with the risk factors noted above that are associated with perinatal depression. These 
include past trauma or adverse events related to being mothered and childhood, role transitions 
that can be exciting but also entail loss and anxiety, social isolation and poverty that increase 
feelings of loneliness, anhedonia, loss and anxiety. Enhanced self-efficacy and a sense of 
mastery can help perinatal individuals navigate these challenges.  
 
Interventions based on interpersonal therapy (IPT), and peer support are proven to be 
effective in decreasing the risk of perinatal depression. Interventions based upon IPT45,46,54,55  
reduce risk of a depressive episode by 50% or more.13 The IPT-based intervention (Reach 
Out, Stand strong, Esssentials for new mothers; ROSE) focuses on areas that place individuals at 
risk for perinatal depression including difficulties with social suport, role transitions and life 
stressors.45,46,55 The paradigm on which ROSE is based focuses on interpersonal change 
processes to reduce stress, increase self-efficacy and ameliorate depressive symptoms.56 This 
intervention was explicity tested in pregnant minority individuals and showed significant benefit 
compared to enhanced usual care.57 Broadly speaking, this intervention can provide a road map 
to enhance self-efficacy and enhance resilience to mitigate risk of depression.58-60 As well, IPT 

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principles may enhance social support through better acceptance and management of the 
interpersonal challenge (i.e. through improved social skills). 
Support provision is critical but does not need to be extensive or in person. Provision of peer 
support also reduces risk of an MDE, particularly among those at highest risk.40,43,61 One 
landmark study illustrating the utility of peer support for perinatal depression provided support 
via telephone24 as well as email and text.41 This finding mirrors evidence from internet-delivered 
interventions for depression, anxiety, and substance use, suggesting additional therapeutic 
benefit from guided electronic interventions (those with some human contact or involvement, 
however brief) over unguided interventions (those with no human contact).62 Researchers 
hypothesize that strong social support increases self-efficacy63-65 and this results in decreased 
risk of depression63; this was shown in a study that used peers.65 
 
Self-efficacy and coping are important targets for decreasing depression risk. Self efficacy, 
or the extent to which people view their ability to exert control over themselves and/or their 
environment, is linked to risk of depression through its effects on hope, optimism and effort. It is 
a critical component of mental health and strong theories link it to risk of depression.63,66-69 Not 
surprisingly, risk factors for depression, such as trauma and childhood adverse events, challenge 
one’s sense of self-efficacy.  Improved self-efficacy is also a key mediator between relationship 
challenges63 and depressive symptoms as well as stressful life events70, including those occurring 
in the perinatal period.65,71 Mastery is related to self-efficacy but adds an emphasis on the ability 
of the self to emphasize control over the meaning and emotional consequences of events.113 
Strong coping skills decrease the risk of perinatal depression.71 They relate to RDOC by 
diminishing negative valence (loss or threat) and enhancing the appreciation of positive events 
(positive valence). Accordingly, we will evaluate whether the proposed TMI engages self-
efficacy and mastery in order to protect against the onset of a major depressive episode (MDE).  
Self-efficacy scales for perinatal individuals focus on the postnatal period and self-assessments 
of parenting abilities and activities, which are hard to assess in pregnancy and before parenting 
starts (for primigravidas). However, general assessments of self-efficacy and mastery may 
provide an area to target for symptom improvement and development of resilience against an 
incident MDE.  
  
Technology based interventions show promising results. Helping perinatal individuals obtain 
the treatment they need can be challenging72; only ~20% of individuals meeting criteria for an 
MDE receive psychological treatment.73 Technological approaches can improve the connection 
with mental health treatment by removing barriers of transportation, lowering cost, reducing 
stigma, and minimizing childcare needs. Digital Health interventions are a viable approach for 
preventing perinatal depression as well.74-83 In general, the majority of programs are web-based 
applications (apps) deployed on computers or mobile devices.  Although such interventions are 
potentially powerful, most have not made it into wider use. Of the mental health apps widely 
available, there is a lack of expert input and testing.84 Whether evidence based or not, apps are 
used infrequently, even after they are downloaded.85,86 Curated databases may help clinicians 
identify apps for their patients87, but patients still need to actively seek them out, register, 
develop user names, passwords, and the user must have adequate internet access as well as 
appropriate devices.88 
   
Text messaging interventions (TMIs) may engage more perinatal individuals compared to 
mobile Health (mHealth) apps. TMIs have a number of advantages that can increase access to 
preventative interventions; they require active consent only once, and then allow repeated, 

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proactive, and direct contact over extended periods of time. Texts allow participants to focus on 
the intervention content through a known user experience with minimum effort required. For 
example, texts can be read automatically when received and indeed, more than 90% of text 
messages are opened and read within a few minutes.89 Text messages are also inexpensive to 
send and receive, can be tailored, personalized and made interactive.88 In this way, TMIs can 
adopt some of the strong features seen in standard web-based programs yet avoid some of the 
issues that arise when using apps.  
 
TMIs are proven to be effective and have a broad reach. TMIs are being deployed to support 
pregnant and postpartum individuals in a variety of domains. A national initiative, Text4Babies, 
was developed in 2010 “to promote healthy pregnancies and babies by the use of text 
messages.”90 Text4Babies and other systems are acceptable to pregnant and postpartum 
individuals, including underserved populations.90 TMIs have significant therapeutic effects on 
attitudes toward alcohol use in pregnancy, smoking in pregnancy, compliance with prenatal 
visits, taking prenatal vitamins and eating fruits and vegetables.91-95 
 
TMIs can be used as an adjunct to ongoing treatment with clinicians for depressed 
individuals. Above we note the feasibility and success of screening via text messaging36,96,97, 
which can identify individuals who need clinician-delivered treatment. As well, TMIs can be 
used as an adjunct to help depressed, perinatal individuals and were used in conjunction with 
nurses making home visits to perinatal women.98 Indeed, a TMI designed to prevent depression 
may require minimal modification to be used as an adjunct to depression treatment in perinatal 
individuals, although that is not the focus of this application. For example, additional 
encouragement for managing role transitions and developing a support network can be beneficial 
for both individuals at risk and individuals in an MDE. 
 
TMIs enhance self-efficacy. Non-enhanced text messages were used as a postnatal educational 
and peer support intervention for first time mothers with the goal of increasing parenting self-
efficacy and decreasing postpartum depressive and anxiety symptoms.64 In the initial pilot study, 
first time mothers were provided education through a TMI that delivered messages twice daily 
for 2 weeks and then daily for one month. The program, which was developed with expert and 
end-user (mothers) input, showed improvements in parenting self-efficacy.99 A developer of this 
intervention is a consultant on the proposed project.  
 
Design features to consider with mobile interventions. As work in this field matures, we can 
now appreciate that a number of components optimize design features of mobile interventions. 
Understanding and empathizing with the needs of the end-user (patient) is important for 
designing engaging mHealth interventions, including TMIs. It is clear that participant input can 
enhance engagement. User centered design (UCD) approaches enhance one’s ability to 
operationalize end-user input. UCD incorporates the needs, preferences, and limitations of end 
users into all phases of product development and implementation.100,101 In practice, UCD 
assesses these areas using repeated, mixed quantitative and qualitative measures to guide the 
design process. This approach allows for iterative refinement and product improvement through 
direct user input to increase the chance that systems work well in the native environment.102-104 
UCD can be applied to the development of TMIs to enhance content for the individuals who will 
ultimately be recipients of texts.   
 
Other features important to health app development include accessibility, privacy/security, 
clinical foundation, and interoperability.87 Compared to web-based apps, TMIs may have less 

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privacy and text messages need to be 
developed with that in mind by avoiding 
highly sensitive or incriminating content; 
but text messages can include links to 
content such as videos and live chat that 
can be provided with a high level of 
security.  
 
Mobile health interventions focused on 
screening and prevention of perinatal 
depression are needed. Despite the 
proven potential of mHealth interventions 
in perinatal depression treatment, what is 
needed is an accessible system to identify 
risk among perinatal individuals and 
provide an intervention to prevent an MDE. This is particularly important for individuals from 
diverse racial and socio-economic backgrounds who may have few resources to care. In this 
application, we propose to apply UCD principles to: 
• finalize and deploy a brief measure to screen pregnant individuals for an MDE and 
depression risk 
• develop a subsequent set of one-way, tailored text messages based upon elements from 
preventative IPT interventions to improve self-efficacy and decrease the likelihood of 
perinatal depression 
• provide peer support through secure chat functionality that will augment intervention 
elements to enhance social support for pregnant individuals at risk of depression.  
 
5.B. Preliminary Studies 
5.B.1. Depressive symptoms prior to an MDE. In the Yale Pink and Blue Study, we enrolled 
2,654 pregnant individuals who had one of the following: were depressed, had a history of 
depression, were undergoing antidepressant treatment, or none of the above. Individuals were 
enrolled prior to 16 completed weeks gestation and were followed until 2 months post-delivery. 
We screened for depression with the EPDS and conducted diagnostic interviews with the 
Composite International Diagnostic Interview. We evaluated symptoms people experienced 
before an incident MDE (n=51) either in the 2nd or 3rd trimester. Figure 1 shows substantial 
distress with > 50% endorsing crying, feeling sad or miserable, overwhelmed, or anxious (scores 
of 2 or 3); fortunately, suicidal thoughts were low.  
   
5.B.2. Screening for depression. Dr. Yonkers has been part of an international coalition to 
evaluate the psychometric properties of the EPDS in relation to diagnostic interviews. We 
contributed data from the Pink and Blue study. Results from 15,557 participants in 58 studies, 
including 2,059 individuals with an MDE indicated an optimal cutoff on the EPDS of 11.105 This 
suggests that an EPDS score of 9 is likely to detect individuals at risk, but not in an episode of an 
MDE. The proposed study will also use CAT-MH for diagnostic information. 
 
5.B.3. Social support and depression in pregnancy. My team evaluated the intersection 
between an MDE in pregnancy, pregnancy timing/wantedness and social support. Secondary 
analyses of our Pink and Blue data showed that individuals who said their pregnancy was poorly 
timed were 3.5 times more likely to be in an MDE94; additionally, individuals who indicated that 
Figure 1: EPDS Items Before Onset of MDE 
 
0
20
40
60
80
100
10. thoughts harming yourself
9. so unhappy been crying
8. felt sad or miserable
7. difficulty sleeping
6. felt overwhelmed by things
5. scared or panicky
4. anxious or worried
3. blamed yourself unnecessarily
2. looked forward with enjoyment
1. able to laugh, see funny…
% selecting option
0 – No, not at all
1 – Not very often
2 – Yes, sometimes
3 – Yes, most of the time

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their pregnancy was poorly timed were nearly twice as likely to score in the bottom quartile of a 
social support measure. In a follow-up, cross sectional study of 161 individuals seeking 
pregnancy testing or termination, over one half of the cohort indicated low social support; 
unplanned pregnancies and depression were both associated with low social support.106 This 
speaks to the role of social support in pregnancy and the possibility that peer support may 
mitigate risk of an MDE. 
 
5.B.4. Computer vs. therapist-delivered screening and brief intervention for individuals 
seeking reproductive health care. Dr. Yonkers was corresponding co-PI of a recently 
completed NIDA-funded trial comparing person-delivered to a CIAS-based brief intervention for 
substance use among individuals seeking reproductive health services. Drs. Ondersma and 
Forray were co-Investigators in this study. Over a six-month follow-up, results of that trial show 
significant reductions in use of the primary substance for individuals in ob-gyn settings assigned 
to either the therapist-delivered or computer-delivered motivationally-based brief intervention, 
vs. an enhanced services condition.107 Although small, effect sizes were more than sufficient to 
support a public health impact (e.g., 0.30 at 3 months and 0.17 at 6 months for the computerized 
intervention vs 0.22 and .06, respectively, for the therapist-delivered condition), particularly 
given the relative ease of implementation and low cost of technology delivered approach. 
  
5.B.5. Integration of technology into prenatal care settings as part of usual care. Dr. 
Ondersma is currently leading a project implementing technology-based screening and brief 
intervention for behavioral health risks in prenatal care settings throughout Michigan. This 
project implements a mobile app that screens for a range of behavioral health risks including 
depression, provides a brief motivational intervention, and facilitates connection to other 
services. The app has been successfully integrated into ongoing clinical care at sites throughout 
Michigan, without provision of any additional funding for the sites, and without any study team 
involvement in the day-to-day integration of the technology. To date, over 5,000 pregnant 
patients have been successfully screened with high ratings for acceptability, high disclosure 
rates, and high rates of motivational intervention completion.  
 
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Participants will be 40 individuals (10 in the pre-pilot and 30 in the pilot study) who are pregnant 
and at risk of, but not in a major depressive episode (MDE). 
 
Inclusion/Exclusion Criteria for Participants: 
 
• English speaking (it will be important to make this available in other languages eventually but 
for this preliminary work, translation processes and testing are not compatible with this scope 
of work and budget limits) 
• “At risk” as determined by an Edinburgh Postnatal Depression Scale score of at least 9, or an 
average score >3 on the 6-item Medical Outcomes Social Support Survey or history of 
depression in pregnancy or postpartum depression 
• At least age 16; we allow individuals who are as young as 16 because this is a high-risk group 
for perinatal depression and information on preventative interventions from this group is 
important 
• Are willing and able to provide informed consent 

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• Are not in a major depressive episode  
• Do not have panic disorder or substance use disorder 
• Are not planning on terminating pregnancy 
• Are willing to use a smart phone to receive texts 
• Are not currently in behavioral health care treatment 
• Are not blind; the text messaging intervention requires that the patient can see 
• Are not permanently living in an institutional setting; many in institutional settings will either 
lack capacity or constitute a vulnerable research group (e.g., prisoners) 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A 
 
9. STUDY TIMELINES* 
Enrollees in the pre-pilot will participate for 4 weeks. We anticipate this will require 6 months to 
complete. 
 
Enrollees in the pilot will participate for 8 weeks, in addition to a 3-month follow-up. We 
anticipate this will take 9-12 months. 
The study will require 36 months. 
 
10. STUDY ENDPOINTS* 
Outcome Measures: 
• The Edinburgh Postnatal Depression Scale (EPDS) is a well validated108, widely deployed, 
10-item scale designed specifically for use with pregnant and postpartum individuals to 
measure depressive symptoms109,110; a cutoff of 13 is the most specific to identify individuals 
who likely have an MDE.111 This will be used to screen for depressive symptoms and as an 
outcome measure. 
• The CAT-MH including the CAT-DI112 is a computerized adaptive test that draws from an 
item bank of 452 items; individuals typically need to answer 12 items to render an accurate 
diagnosis of an MDE. The CAT DI module has a sensitivity of 0.92 and specificity of 0.88 
when compared to the Structured Clinical Interview for DSM-IV. The CAT-MH is integrated 
into CIAS 3.0, allowing for seamless integration with other assessments. This will determine 
who has depression and needs intervention at the outset of the study (exclusion criteria) and 
will be used as an outcome measure to determine if the intervention decresed the risk of an 
MDE or anxiety disorder. 
• The General Self Efficacy Scale (GSE scale)68 has 10 items scored from 1-4 that measures an 
individual’s belief that she can respond to novel or challlenging situations. It takes ~2-4 
minutes to complete, has a Chrombach’s alpha of 0.82-0.93 and in individuals, is a single 
factor and correlated highly with self esteem and optimism. This is a target of the 
intervention that is putatively linked with depression risk. We evaluate whether the TMI 
changes self-efficacy and hence risk of an MDE. 
• The Pearlin Mastery Scale (PMS)113 has 7 items that are scaled 1-4 (1= strongly disagree to 
4= strongly agree) with a range of 7-28, and low scores indicating low mastery (Chronbach’s 

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alpha=0.78). This is also a target of the intervention and may be associated with lower risk of 
worsening depression. 
• System Usability Scale114 has 10 items and is scored 1-5 (strongly agree to strongly 
disagree). Scores are summed and multiplied by 2.5. A score of greater than 68 is considered 
above average. This is a measure of acceptability that bears on ability to implement the 
system. 
• User Engagment Scale – short form115 is a 12 item scale that scores from strongly disagree to 
strongly agree (1-5).  It has 4 subscales with 3 items each.  The subscales are Focused 
Attention; Perceived Usability; Aesthetic Appeal; Endurability. The overal reliability (w) was 
0.88 in formative work; subscales have reliability that is close to this statistic. This is an 
additional measure of acceptability and hence ability to implement the TMI. 
 
 
11. PROCEDURES INVOLVED* 
   
Text4Moms intervention and design. Text4Moms will consist of four primary components.  
• First, it will include a screening tool that will triage individuals to immediate care (an 
MDE, depressive symptoms or no-minimal depressive symptoms). We envision that the 
screener will include questions from the EPDS108 but will also run a Computerized 
Adaptive Technology program called CAT-MH.112 This program was integrated into 
CIAS and by clicking a link, participants can run CAT-MH.  The program uses adaptive 
branching to select questions that determine whether the participant likely is in an MDE 
episode and thus requires a higher level of care.  
• Second and most centrally, Text4Moms will include tailored text messages that are 
readily accessible to participants and, after consent is obtained, will arrive without 
requiring the participant to seek them out. This novel pro-active approach can enhance 
engagement among participants.  
• Third, Text4Moms will include extended content that will be available as a simple link 
within text messages. We estimate that approximately half of all Text4Moms messages 
will include a link. Content will be kept extremely brief to increase the likelihood that 
even modestly motivated participants will click. All extended content will provide 
information regarding how to find additional information and higher-level support and 
will come in two forms: a) brief videos, tailored to participant needs and characteristics 
and designed to be consistent with the ROSE prevention models; and b) interactive 
micro-interventions approximately 60 seconds in duration, built using CIAS. These 
micro-interventions can themselves include brief video content or can involve short 
interactions with an animated narrator in which the participant can securely indicate their 
feelings or preferences and receive reflections and tailored information in response.  
• Fourth, Text4Moms will include on-demand live chat access to a trained peer navigator 
who has access to pre-populated scripts. Available through a text message link or a link 
within a CIAS micro-intervention, this feature will allow secure (silent and end-to-end 
encrypted) contact with a peer who can provide social support or assistance with 
accessing services.  
 
 Peer Support. Our training of peers will be assisted by input from our consultants Dr. Cynthia 
Dennis who has conducted many studies in this arena; and Dr. Wendy Davis, Executive Director 

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of Postpartum Support International (PSI). We anticipate recruiting qualified peers from PSI and 
local resources. Peers will also receive training on how to be a peer, the limits of a peer, safety 
protocols for participants who show clinical worsening, including suicidal or homicidal ideation 
and use of the CIAS platform, all following adapted versions of existing peer training and 
supervision materials developed by Dr. Dennis, with ongoing support provided through regular 
meetings with the project manager (trained and supervised by Dr. Dennis). Importantly, all chat 
conversations between peers and participants can be readily reviewed and monitored, facilitating 
accurate supervision and support. Support materials, protocols, and texts to provide participants 
will also be available on the CIAS dashboard. 
 
Peers will interact with participants using a dashboard within CIAS allowing them to view 
multiple chat threads at once message with participants one at a time, and access manualized 
content/key resources from a library of available messages. Through these four components, the 
Text4Moms intervention will be high-reach and low-burden, with a very high proportion of 
participants getting at least some key content. At the same time, the provision of attractive and 
brief extended content may allow participants with greater needs to receive assistance where and 
when they want it, ranging from simple information provision to direct interactions with a 
trained helper.  
 
Aim 1: To iteratively develop the Text4Moms screening form, tailored text messages, video 
content, peer navigator manual and understand the population for whom it is needed. The 
development process is outlined in Figure 5. This addresses step 1 in PAR-21-131 in that it will 
help us understand the target population and ensure that the intervention is appropriate for the 
patients, providers, and settings relevant to perinatal depression. We will draw upon the literature 
with regard to behavioral interventions to prevent peripartum depression as well as new material 
from mHealth interventions for depression that employ text messages. We will collect expert 
opinion from two groups: 1) a Patient Guide Group (PGG) that consists of a diverse group of 
individuals with lived experience of perinatal depression, and 2) an Expert Advisory Board 
(EAB) comprised of team members and consultants with clinical and research experience in 
perinatal depression prevention and support of peer navigators (Drs. Dennis, Johnson, Davis, 
Forray and Zlotnick). 
 
The core research team will develop a moderator guide to query information. This will be vetted 
with the EAB. The core team will interview individuals with lived experience of depression from 
the PGG and conduct a needs assessment that provides information directly from individuals 
including: 
• their struggles with depression and areas where they perceive help would have been 
beneficial 
• their course of illness and when help would have been needed and accepted 
• barriers to receiving texts, engaging with video links, and using the chat function 
• factors to tailor on that would help with engagement 
• lessons to amplify with video texts that would make them more useful 
• ways peers can be helpful  
• areas to avoid if possible  
• acceptable quantity (e.g., up to 5 messages per week), frequency (e.g., no more than once a 
day or every other day), and timing (e.g., between 10AM and 4PM) of text messages 

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• ways in which the intervention can fit in with perinatal care 
The EAB will contribute expertise on:  
• important areas of focus 
• perceptions of the active ingredients from existing interventions that could be used in texts 
and amplified in video content. While some are noted above, they will be flushed out during 
the development process. 
• tailoring factors, which are powerful components of engagement. Candidates include: 
race/ethnicity, age (adolescent up to age 22 vs older mother), marital status, stage of 
pregnancy, etc. 
• areas where video examples are needed to illustrate lessons (e.g., how to interact assertively, 
to problem solve, to engage others in support) 
• materials needed to support peer navigators who communicate with participants over “chat” 
functionality 
• protocols for peers to help manage and refer participants who may evidence clinical 
deterioration, including suicidal and homicidal ideation 
• ways the intervention can fit with perinatal care sites 
• how to include perinatal providers. 
 
After individual PGG interviews are completed, the core team will develop a message bank, peer 
support materials, CIAS micro-interventions, and videos. Additionally, we will search the 
internet and educational resources for open-source video content. The PI and Co-I Tulu will 
convene the EAB. Using a ‘think-aloud’ approach116, we will ask members to think aloud while 
reviewing topics, messages, and possible video content. A member of the research team will take 
notes to capture comments and suggestions. It is likely that additional video content or revisions to 
available content will be needed. Accordingly, we will encourage ‘virtual white board’ drawings of 
suggested video content and animations.117 We will draft video content using virtual storyboards, 
sketches, and accompanying script. After the group has reached 80% consensus on the utility of 
prototypes, they will be presented to the PGG. We anticipate at least 2-3 meetings of the PGG to 
review and iteratively improve the materials developed by the research team and EAB. Iterations 
will include a health literacy evaluation to ensure that audiences who have a low level of literacy 
will find texts understandable.118 From the PGG, we will elicit feedback on the content 
modification. Dr. Tulu’s team will develop the new multimedia components, if needed. We will 
also solicit input on the message frequency and timing and peer helpfulness.  

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As part of the development process and to test the TMI in the field, we will conduct a pre-pilot 
study of 10 pregnant individuals, the recommended number of individuals for usability testing.119 
We will follow the approach outlined for Aim 2 (see 3.C.4.e) except there will be no 
randomization and the intervention timeline will be shortened. The pre-pilot participants will be 
either before 16 weeks or in the end of their third trimester of pregnancy and will participate for 
4 weeks in order to capture various stages of pregnancy and the postpartum period. We will 
stagger recruitment and have 2 groups of 5 participants. The first group will start the pre-pilot at 
time T1, and the second group starts at time T1+1 month. This will allow us time to collect 
feedback after 2 weeks from group 1 and make adjustments (if any) needed to improve the 
intervention for the second group. The pre-pilot is important since it will allow us to evaluate the 
usability issues that can come up only after repeated use in the users’ native environment, 
allowing us to address these issues before proceeding to a feasibility pilot. We will also be able 
to pre-pilot the peer mentor chat support. This step will confirm that all major issues related to 
use and usability are resolved before going into the pilot, which entails a 2-month intervention 
and 3 months follow up. Based on the feedback, which will focus on the points covered in PGG 
meetings, usability of the technology and acceptability of the intervention, we will make a final 
set of refinements to the multimodal intervention and move to a pilot study.  
 
Aim 2 & 3: Evaluate preliminary efficacy, mechanisms, and implementation of Text4Moms 
in a pilot randomized trial. 
Inclusion/Exclusion Criteria. We realize that the sample size for the pilot is small and will seek 
to recruit a cohort that is racially, ethnically, and socioeconomically diverse. Individuals will be 
eligible if they are: a) “at risk” as determined by: an EPDS108 score of at least 9, or an average 
score >3 on the 6-item Medical Outcomes Social Support Survey (MOS)120, and/or history of an 
MDE in pregnancy or postpartum depression;55,121 b) at least age 16; c) willing and able to 
provide informed consent. We allow individuals who are as young as 16 because this is a high-
risk group for perinatal depression and information on preventative interventions from this group 
is important. Pregnancy confers “emancipated” status in Massachusetts, so these adolescents will 
be able to provide consent for participation. Pregnant individuals who are younger than 16 are 
uncommon in our setting.  
 
Individuals will be excluded if they: a) are in an MDE, have panic disorder or substance use 
disorder; b) are planning on terminating pregnancy; c) do not want to use a smart phone to 
receive texts; d) are currently in behavioral health care treatment; e) do not speak English. While 
Figure 5: TMI Development Plan

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our software can accommodate other languages, the research team will vet the information sent 
via chat and it is preferable to do this in English during the intervention development phase. 
Future work will not include this exclusion and will explore cultural tailoring that goes beyond 
language. 
 
Recruitment: See #24 
  
Enrollment: The full trial consent will also be presented electronically with study staff on the 
phone and available to answer questions. Drs. Yonkers, Forray and Ondersma are currently using 
this method for consent in their other studies. Participation will proceed only if individuals 
provide written informed consent via e-signature. This functionality is available in CIAS 3.0. 
Participants who meet all eligibility criteria and provide consent will then be randomly assigned 
to either educational texts or Text4Moms after completion of the baseline assessment. We will 
monitor recruitment for diversity. The staff member who enrolls the participant will not have 
access to the assigned condition/content, which will aid in blinding study staff.  
 
Clinical Trial Process Procedures  
Assessments. After the participant signs consent, we will send her a link to complete a REDCap 
baseline assessment that includes questions not necessary for eligibility but are important for the 
study: 
• Additional necessary demographic/contact/treatment information 
• Additional history of depression/anxiety/psychosis 
• Questions that identify domains that the patient identifies as challenging (e.g., low self-
esteem, difficulty with role transitions) 
• Questionnaires in Table 1 
 
The baseline assessment will be short and will not duplicate information from the screening and 
eligibility assessment. Individuals will receive a brief reassessment at 4 weeks that includes the 
EPDS, the CAT-MH, the General Self Efficacy Scale (GSE Scale), the System Usability Scale 
(SUS)114 and User Engagment Scale (UES)115 that will allow us to collect and address areas 
related to usability and ensure the intervention content is accessible to all participants. There will 
be an 8 week assessment that repeats these questions and the CAT-MH. The final assessment 
will also include the SUS and UES as well as questions on satisifaction of the system, relevance 
to their issues, what they liked about the system, and what they did not like. Study staff will 
contact all participants at 3 months to obtain additional qualitiative input. The research team will 
also evaluate the number of individuals who ask to stop texts, number of texts received, and 
number of links that are opened. 
 

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• Select items from the Inventory of Depressive 
symptomatology (QIDS)122 that map onto RDOC 
domains51 of negative valence (loss and threat) 
and positive valence (hedonia and reward): 
impaired capacity for pleasure, impaired general 
interest, impaired mood response to desired 
events, impaired energy level for reward and 
feeling anxious or tense, panic/phobia, 
interpersonal sensitivity for loss and threat. This 
will illustrate salience with RDOC constructs that 
map onto neural pathways that are putatively 
linked with depression. 
• The CAT-MH including the CAT-DI112 is a computerized adaptive test that draws from an 
item bank of 452 items; individuals typically need to answer 12 items to render an accurate 
diagnosis of an MDE. The CAT-DI module has a sensitivity of 0.92 and specificity of 0.88 
when compared to the Structured Clinical Interview for DSM-IV. The CAT-MH is integrated 
into CIAS 3.0, allowing for seamless integration with other assessments. This will determine 
who has depression and needs intervention at the outset of the study (exclusion criteria) and 
will be used as an outcome measure to determine if the intervention decreased the risk of an 
MDE or anxiety disorder. 
• The General Self Efficacy Scale (GSE scale)68 has 10 items scored from 1-4 that measures an 
individual’s belief that she can respond to novel or challlenging situations. It takes ~2-4 
minutes to complete, has a Chrombach’s alpha of 0.82-0.93 and in individuals, is a single 
factor and correlated highly with self esteem and optimism. This is a target of the 
intervention that is putatively linked with depression risk. We evaluate whether the TMI 
changes self-efficacy and hence risk of an MDE. 
• The Pearlin Mastery Scale (PMS)113 has 7 items that are scaled 1-4 (1= strongly disagree to 
4= strongly agree) with a range of 7-28, and low scores indicating low mastery (Chronbach’s 
alpha=0.78). This is also a target of the intervention and may be associated with lower risk of 
worsening depression. 
• System Usability Scale114 has 10 items and is scored 1-5 (strongly agree to strongly 
disagree). Scores are summed and multiplied by 2.5. A score of greater than 68 is considered 
above average. This is a measure of acceptability that bears on ability to implement the 
system. 
• User Engagment Scale – short form115 is a 12 item scale that scores from strongly disagree to 
strongly agree (1-5). It has 4 subscales with 3 items each. The subscales are Focused 
Attention; Perceived Usability; Aesthetic Appeal; Endurability. The overal reliability (w) was 
0.88 in formative work; subscales have reliability that is close to this statistic. This is an 
additional measure of acceptability and hence ability to implement the TMI. 
 
Study Process: After randomization, participants will be sent texts 3-4 times per week (this may 
change depending upon input from the PGG). Texts will be short and for the TMI, will include 
video links that reinforce information relevant to IPT. Texts will also be tailored for stage of 
pregnancy, history of perinatal depression, and possibly other factors such as age depending 
upon input from the PGG and the EAB. Texts will continue for 8 weeks unless the participant 
elects to “STOP” texts. They will include a button that will invite individuals to chat with a peer.  
 

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Control Condition: The control condition will be limited to texts related to pregnancy, nutrition 
and sleep and will avoid elements that have behavioral therapeutic effects. We will develop a set 
of texts from openly available information about healthy pregnancy. Although this condition is 
meant to constitute time and attention control as recommended by an NIH expert panel123, we 
will include material on recognizing depression and links to ways to attain depression treatment 
and suicide hotline information. 
 
Peers: We will employ 2-3 individuals as peers; these will be individuals who experienced 
perinatal depression or were close to someone with perinatal depression. We will recruit from 
social media, contact providers and the local chapters of PSI.  Peers will be encouraged to cluster 
their texts and will be paid hourly for training and meetings and a modest amount for each text 
(~$5). CIAS 3.0 will include a variety of phrases, messages and resources that can be copied and 
pasted into the chat and thus help peers with messaging about content. Chats will be monitored 
by the study team. This will ensure the safety of participants and peers and will allow the study 
team to know if the content is being utilized. Peers will have a safety protocol should a 
participant experience psychiatric worsening and/or develop suicidal ideation. 
 
Randomization. The 30 participants for the pilot will be randomized in a 2:1 ratio for 
Text4Moms: Educational control. We acknowledge that the short duration of an R34, and the 
need to spend at least a year building the system, limits our follow-up period. To collect 
information about the TMI functionality at various times in pregnancy and after delivery, we will 
stratify enrollment to 15 individuals who are before 24 completed weeks of pregnancy and 15 
who are after 24 completed weeks of pregnancy. This will allow us to pilot the TMI in all phases 
of pregnancy and the postpartum period since the TMI will endure for 8 weeks. The statistician 
will generate an allocation sequence for a random-permuted block randomization using 
identification numbers. After a participant meets criteria and provides consent, the statistician 
will email the research assistant (RA) the randomization condition. The RA will have no prior 
knowledge of the randomization sequence. Randomization will occur by the toss of a coin and 
will not rely on factors other than the stratification.  
 
In year 2, we will recruit 10 individuals who are pregnant for a pre-pilot who will participate for 
4 weeks. We will reimburse them $20 for screening, $25 at baseline, $25 at 2 weeks, and $25 at 
4 weeks (Total= $95 each). Toward the end of Year 2, beginning of Year 3, we will recruit 30 
individuals for an 8-week pilot randomized clinical trial with a 3-month follow up. They will be 
reimbursed $20 for screening, $25 at baseline, $25 at 4 weeks, $25 at 8 weeks, and $25 at 3 
months (Total= $120 each). We include $700 in years 2 and 3 for screening reimbursement. All 
compensation will be in the form of an Amazon gift card.  
 
 
12. DATA AND SPECIMEN BANKING* 
 
De-identified data will be stored in the National Library of Medicine (NLM) on 
clinicaltrials.gov. Results information will be submitted and will not include individual patient 
data. Following completion of the study, all identifiers will be permanently deleted after the final 
report to the sponsor has been completed 
 
13. Data Analysis and Management* 

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Data will be collected by tablet and email links in REDCap. Our statistician at Yale will manage 
the data. To evaluate acceptability and use characteristics, we will collect descriptive statistics on 
satisfaction, helpfulness, and ease of use (SUS and UES) for the Text4Moms system and 
components (including chat), measured at the intervention (week 8). For engagement, data from 
the Text4Moms system will be reported showing the percentage of individuals who engage with 
Text4Moms and read at least 80% of texts and the percentage of individuals who engage with the 
chat. Qualitative responses from participants will offer further insight into these outcomes.  
 
For efficacy outcomes, total scores on EPDS, GSE and PMS113 (scales) and the onset of an MDE 
will be reported using means and standard deviations; frequencies and percentages for the EPDS, 
GSE and PMS scores will be reported as linear variables. Multiple regression will be used to test 
for differences in the EPDS, and the GSE and PMS scores between treatment groups at week 8, 
adjusting for baseline scores. Generalized estimating equations will be used to explore if changes 
in EPDS, GSE and PMS scores varied over time from baseline to week 4 and week 8. We will 
also examine whether the percentage of individuals who experience an MDE at week 4 and/or 
week 8 differed between treatment groups using chi-square tests.  
 
We will test for target engagement by measuring changes in the self-efficacy construct (GSE and 
PMS) between the 2 groups at 4 and 8 weeks.  We will do the same for RDOC constructs 
measured with IDS-SR items. As an exploratory analysis, we will estimate correlations between 
EPDS scores and the GSE and PMS scores with treatment. We note power is not sufficient to 
detect mediating effects. 
 
Sample Size. Leon, Davis, & Kraemer state (2011) that “power analyses should not be presented 
in an application for a pilot study that does not propose inferential results”.124 Indeed, pilot 
studies are not expected to be fully powered. Instead, we based our sample size on accepted 
practice for pilot studies, the considerable experience of the research team, and practical 
considerations.125 As a pilot study, we are powered at 80% to detect large effect sizes on 
continuous outcomes (d>1.1) with 20 participants in the Text4Moms group and 10 in the control 
group and a two-tailed alpha of 0.05. However, we include benchmarks of d>0.20 for the EPDS 
and possible mediators since this is consistent with the effect size for many digital interventions 
in the literature. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
This project is considered minimal risk since a text messaging intervention (TMI) is envisioned 
to enhance the likelihood of detecting, referring, and decreasing the likelihood for a major 
depressive episode in perinatal women. The control condition includes educational texts. Thus, 
no DSMB is planned although we present a Data Safety and Monitoring Plan (DSMP).  
 
The Principal Investigator will have the primary responsibility for monitoring data. The PI and 
their team (project manager and data manager) will review any sensitive data such as 
endorsement of suicidal ideation daily. We will monitor the texts as well as the results of the 
assessments outlined above (eg. EPDS, GSE, IDS, CAT-MH, Pearlin Mastery Scale). The 
research assistant (to be hired), with the assistance of the statistician, will prepare materials for 
weekly meetings to review the aspects of the pilot project, including recruitment, retention, and 
possible adverse events. This will be presented to the core team and consultants as needed. 

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Identified data will be collected only after provision of consent and will be de-identified for 
analysis. No personal health information will be used in any publications. Given the low risk and 
pilot nature of the project, there are no stopping rules. 
 
Although this study presents minimal risk to participants, there is some risk that a participant's 
responses might become known against their will. Additionally, because text messaging takes 
place via cellular service providers, it is an insecure technology that does not allow for 
encryption. Finally, text messages on a participant’s phone can potentially be seen by others with 
access to that phone. All participants will be made aware of any potential security risks. While 
links may not have enduring or searchable material, some of the texts might. Thus, we will be 
very careful when crafting text to not reveal any information unless it is necessary. 
 
There is always a risk that participants will experience clinical worsening, including suicidal 
thoughts and psychosis. We are partnering with Postpartum Support International for peer 
support. They currently have a warm line throughout the country to which participants may be 
referred. As of the summer of 2022, and through the support of SAMHSA, they will also have a 
clinician staffed “hotline”. Our texts will remind participants of these resources. If one of our 
peers is contacted off hours, they will be sent a message with these resources. As well, we will 
ask permission to contact their reproductive health provider should clinical worsening occur. We 
will share necessary information with the provider and will give the provider resources that are 
shared with the participant. 
 
We will educate all peers on perinatal depression, evaluation of clinical worsening and 
suicidal/homicidal ideation. Additionally, they will be trained in protocols to follow should a 
participant disclose suicidal or homicidal ideation and will be provided with scripts and text that 
can help them manage this. Any such disclosure will also loop in the project manager and the 
Principal Investigator or a covering physician. Resources will be available on the dashboard for 
peers to provide participants. We will follow up with participants on the use of resources and 
how they are feeling after any indication of worsening. 
 
The peers will be trained on the use of the text messaging intervention, will be monitored, and 
provided support on how best to use the system and provide support as a peer. We will provide 
training to the peer on the limits between being a “peer” and a treating clinician. We will have 
group meetings to trouble shoot and support peers. Protocols that are helpful to peers will always 
be available on the CIAS dashboard. 
 
The PI will distinguish between SAEs and non-serious AEs, and will also make attributions 
regarding causality and severity. She will use the FDA definition of serious adverse events 
(SAEs). She will send a report of SAEs to the IRB. Any additional information regarding either 
an SAE or an unanticipated problem will be submitted as a follow-up report to the IRB within 15 
calendar days of receiving the information. In the event that a participant either withdraws from 
the study or the investigator decides to discontinue a participant due to an SAE, the participant 
will be monitored by the investigator via ongoing status assessment until (1) a resolution is 
reached; (2) the SAE is determined to be clearly unrelated to the study intervention; or (3) the 
SAE results in death. 
 

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15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
N/A 
 
16. RISKS TO SUBJECTS* 
The potential risks in this study are loss of confidentiality for participants. Although not due to the 
study, we may also identify individuals in an MDE or who have suicidal thoughts. 
 
Loss of Confidentiality:  
A research assistant, Project Director, or Investigator will obtain verbal and written/virtual 
consent to screen and then enroll. Information will all be coded under a subject ID and kept on 
password protected data bases and in double locked files in the offices of research staff. 
In addition to being made aware of possible risks via the consent process, participants will be 
protected against potential risks in several further ways. 
1. The use of technology for gathering self-report data enhances participant protection, in that 
participant data or group assignment will not be available to anyone in the participant’s clinic or 
hospital setting. Even the research assistant is unable to access participant responses. 
2. The web-based CIAS software in this study uses 256-bit AES encryption in order to protect 
data in transit from the participant’s electronic device to the dedicated and secured server on 
which the software resides. CIAS resides on a HIPAA-compliant MSU server with data 
encryption at rest, dual-factor authentication, malware protection, 24 x 7 monitoring of event 
notification, and a dedicated and fully managed firewall with active intrusion detection and 
prevention and access tracking.  
3. Possible distress will be noted clearly in the informed consent information sheet, which will 
also indicate that a referral for counseling is available from the RA. In addition, in order to 
prevent risk regarding guilt, all intervention content is phrased as positively as possible. We will 
have staff available during the day should someone require immediate evaluation for depression 
or suicidal ideation. 
4. The informed consent information sheets will explicitly acknowledge the limited security of 
text messages, both because they are not encrypted, and because the participant’s phone itself 
may be accessible to others. Further, text messages—although tailored—will be written in a way 
that does not imply any details of the participant’s mood; that is, they will look like general 
advice that might be provided to any pregnant individuals. Finally, participants will be informed 
that they can end the text messaging plan at any time by texting back “STOP.” 
 
Depression Risk and Management of Suicidal Patients:  
We will monitor depression screening results and scores as reflected on the EPDS and CAT-DI. 
Scores indicating severe risk will result in an alert to the study team, who will evaluate risk and 
ensure that referrals for treatment are provided. We will have systems in place to immediately 
assess and refer individuals who endorse severe depression or suicidal ideation. Psychiatrists on 
the team can conduct an immediate assessment and contact the patient’s obstetrical provider; 
UMass has a psychiatrist embedded in the clinic who can follow up with care. Beyond this 
project, a screener such as the one embedded in this form, if shown useful, can be used in non-
research clinical settings to identify individuals who are depressed as well as those at risk of 
perinatal depression. In addition to local resources, we have access to the Massachusetts McPAP 
for Moms program, housed in the Department of Psychiatry at UMass, and the warm/hotline 

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staffed by PSI. Our consultant, Dr. Dennis, conducted studies that provided telephone and text 
support to high-risk pregnant individuals across Canada. She has protocols for managing the 
disclosure of suicidal ideation that could be deployed in a larger study. Thus, the study will allow 
us to pilot referral systems as well as the screener itself that can be used in a broader context. 
 
It is possible that participants will disclose suicidal ideation during the evening or weekend when 
no one is available in the chat. Our pilot data suggest that suicidal thoughts are uncommon in 
perinatal women, even prior to MDE onset but when they occur, they must be managed since 
safety is a major concern. Some interventions attempt to solve report of suicidal thoughts or 
feelings by not asking about them. Our impression is that this does not address the problem but 
instead hides it. While 24-7 staffing of the system raises feasibility issues, we can instead 
leverage widely available resources such as the PSI suicide hotline that will be staffed 24-7 by 
clinicians starting the summer of 2022.  Should a participant endorse suicidal thoughts off hours, 
CIAS 3.0 will be programmed to provide a statement such as, “It sounds like you are having a 
difficult time and we are concerned about how you are feeling…” and will include contact 
information for suicide hotlines and 211 numbers. The content of the chat will be checked in the 
morning and throughout the day to monitor for the expression of such statements and safety 
procedures will be followed.  
 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
There are several potential benefits to the proposed research: First, screening may identify 
individuals with depression or another disorder who require treatment. Members of the study 
team will be able to refer these individuals for treatment. Two, the project will recruit high-risk 
women who otherwise may go on to develop an MDE. They may be less likely to do so in either 
condition but especially the intervention condition. Even individuals in the control condition will 
be provided with information on depression and treatment resources. Three, we will be 
monitoring participants for onset of an MDE, suicidal thoughts and worsening of depression. We 
will have the opportunity to refer participants to a higher level of care at any point.  
 
 
18. VULNERABLE POPULATIONS* 
 
The project will only enroll pregnant individuals into the pre-pilot and pilot trials since we are 
attempting to decrease risk of an MDE in perinatal individuals. Criteria for randomization 
include children between the ages of 16-18 because this is a high-risk group for depression. The 
characteristics of this group may differ substantially from pregnant women in their 20s to early 
40s and merits exploration of interventions particularly geared to this group. Pregnancy confers 
“emancipated” status in Massachusetts, so these adolescents will be able to provide consent for 
participation.  
 
We do not anticipate the research to involve more than minimal risk to these vulnerable 
populations, and a DSMP will monitor the safety of subjects, which is detailed above in #14. No 
inducements, monetary or otherwise, will be offered to terminate a pregnancy. Individuals 
engaged in the research will have no part in any decisions as to the timing, method, or 

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procedures used to terminate a pregnancy. Individuals engaged in the research will have no part 
in determining the viability of a neonate.  
 
19. MULTI-SITE RESEARCH* 
 
Recruitment will only occur at UMass Chan School of Medicine. The University of 
Massachusetts Medical School IRB will serve as the selected IRB with a request to Yale IRB, 
WPI IRB, and Michigan State University IRB to concede review. We have subcontracts at Yale 
and WPI. The UMass project director or designee will coordinate communication regarding IRB 
submission and modifications. We will hold monthly administrative and operations team 
meetings with participation by appropriate personnel at each study site. Telephone and email 
communication will also be used as needed. All identified participating sites will agree to rely on 
the proposed sIRB. Participating sites will sign an authorization/reliance agreement that will 
clarify the roles and responsibilities of the sIRB and participating sites. UMass will maintain 
records of the authorization/reliance agreements and of the communication plan. All engaged 
participating sites safeguard data as required by local information security policies. All local site 
investigators will conduct the study appropriately. All non-compliance with the study protocol or 
applicable requirements will be reported in accordance with local policy. All sites will be 
informed of problems, interim results, and the study closure.  
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
 
We will share the results of the diagnostic evaluation (CAT-MH) with potential and enrolled 
participants. This will be done by the project director (a masters or Ph.D. level clinician) with the 
supervision of the PI. This will allow us to arrange for treatment and follow up. Similarly, any 
mention of self or other harm will be immediately evaluated and any assessment will be shared 
with the participant. 
 
22. SETTING 
 
Participants will be recruited via flyers, social media, and information sheets placed in UMass 
prenatal care and other obstetric sites and assistance from obstetrical providers. Although most of 
recruitment will be completed virtually, patients may also complete a form on-site that includes 
their name and phone number; it can be placed in a box at their prenatal site and collected for 
follow-up by study staff.  
 
23. RESOURCES AVAILABLE 
 
The staff for the project include: 
 
1) Principal Investigator who is responsible for the overall supervision of the project. This is 
a doctorate level position that will be filled by the person who designed the project and 
received funding. This is a person with a history of conducting NIH projects. (20.0% FTE) 

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2) Co-Investigators who will work on the build of the TMI and the clinical trials. These are 
doctorate level collaborators who have expertise to contribute to the project, i.e., building 
TMIs and apps, etc. (2%-15% FTE) 
3) Project manager who will work closely with the PI and other members of the team. This 
is a masters to doctorate level person who has the expertise to oversee the components of 
a small field study. (25% FTE) 
4) Research Assistant who will help with administrative tasks and recruitment and follow-
up. This is a bachelors to masters level individual who can be trained to assist the Project 
manager with various aspects of the project. (25% FTE) 
5) Graduate student/post doc who will help with the TMI build (20% FTE) 
6) Statistician who will develop data base, monitor its functionality, and conduct analyses. 
This is a masters level person who has experience developing data bases, cleaning data, 
and conducting analyses. (5% FTE) 
7) Expert consultants who will provide input into the TMI and work to be done recruiting 
and training peers (1-2% FTE) 
8) Peer consultants with lived experience who will provide guidance on content and 
usability of the TMI during the build 
 
We will share the IRB and protocol with all investigators and consultants. We will also write a 
protocol paper that can be published. We will meet with clinical sites to explain the project and 
the recruitment needs and procedures. 
 
24. LOCAL RECRUITMENT METHODS 
 
The flyers and sheets will contain basic information indicating that we are recruiting for a health-
related study that will include pregnant individuals at least 16 years of age; materials include a 
website and a QR code with minimal information and a link to the study website. The website 
information sheet will:  
• Provide basic information on the study (it evaluates stress and health habits across pregnancy 
and the postpartum period and provides information on pregnancy and health) 
• State broadly who we are looking for (individuals who are pregnant, not planning to 
terminate their pregnancy, and willing to use a smartphone) 
• Indicate what participants will be asked to do (be willing to receive text messages on a 
smartphone and complete several short assessments).  
• Inform them that they if they are interested, they can complete a form (i.e., the study 
eligibility form) and will be reimbursed $20 for their time. Those who click “I agree to find 
out more” at the end of the information sheet will then be offered the computer-directed 
eligibility survey programmed in REDCap.  
 
Individuals who elected to fill out a form by paper will be called by or meet with research staff 
who will obtain consent to screen the possible participant, explain the study, and obtain 
information about access to a personal smartphone. Staff will work with possible participants to 
complete eligibility questions. We provide this option to determine how much a barrier 
ownership or use of a smart phone will be and whether a completely virtual enrollment process 
for this project is feasible. We acknowledge that smart phone ownership and use is high (>95%) 
but is somewhat lower (>85%) among minority individuals. It is important that the intervention 
and its elements be available to a diverse group of individuals. We will not exclude individuals 

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but to ensure smart phone ownership is not a substantial barrier, we will provide individuals with 
a smart phone and a data plan; this will allow them to receive texts and click on links that are 
provided in our messages.  
 
This eligibility survey will be structured in such a way that the study’s inclusion and exclusion 
criteria are not readily apparent (to minimize risk of fraud), until the end of the survey, when a 
diagnosis of MDE is excluded. For example, we will ask information on demographics, nutrition 
health habits, exercise, thoughts about breastfeeding as well as mood and past history of 
depression. The eligibility survey will include the “screener.” The final step will be 
administration of a Computerized Adaptive Testing-Mental Health (CAT-M) including the 
depression diagnostic module (CAT-DI) and anxiety modules to confirm that someone is not in 
an MDE and does not have panic disorder or a SUD. These individuals require treatment rather 
than the proposed intervention. The eligibility survey will also include the potential participant’s 
prenatal care site and permission to contact the site in case there is a medical problem they 
report, including thoughts of self-harm. Possible participants will be emailed a $20 Amazon gift 
card as reimbursement for their time. 
  
After a potential participant completes the eligibility form, study staff will contact her by 
telephone in order to validate her eligibility (survey completed by a real person who can 
communicate in English, has a working smartphone, or agrees to use one provided by the study 
team, is willing and able to receive text messages, and understands study requirements). The 
following strategies will be implemented to reduce the possibility of fraudulent participation for 
those not seen face to face: 
• Manual review of IP addresses to screen for duplicates, identify addresses of non-US origin, 
and detect fraudulent completion (e.g., bots)  
• Manual review of REDCap survey data to detect suspicious response times (e.g., completing 
the survey too quickly), unusual patterns in responses, respondent names, respondent email 
addresses, and patterned completion timestamps indicating that one person/bot is completing 
the survey repeatedly until eligible 
• Inclusion of a required open-ended narrative response to detect fraudulent completion.  
 
IP addresses will be deleted from the participant’s screening data when no longer needed. 
Unnecessary eligibility data will be deleted from those who do not qualify, and remaining 
information will be de-identified.  
 
We will have access to several thousand pregnant individuals locally and more via the internet. 
The number of pregnant individuals for the pre-pilot is 10 and for the pilot is 30. Past experience 
by the PI indicates little concern for this level of recruitment. In the past, she recruited and 
followed 2800 pregnant individuals in CT and MA through pregnancy and the postpartum 
period. 
 
 
25. LOCAL NUMBER OF SUBJECTS 
 
For the pre-pilot and pilot studies we will recruit 40 individuals. We assume we will have to 
screen 200 individuals to fill this number.  
 

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26. CONFIDENTIALITY  
 
The use of technology for gathering self-report data enhances participant protection, in that 
participant data or group assignment will not be available to anyone in the participant’s clinic or 
hospital setting. All data will be stored under a participant number and not a name that can 
identify the individual. Even the research assistant is unable to access participant responses or 
information about group assignment. 
 
Data will be electronically captured in CIAS or REDCap. Web-based CIAS software in this 
study uses 256-bit AES encryption in order to protect data in transit from the participant’s 
electronic device to the dedicated and secured server on which the software resides. CIAS 
resides on a HIPAA-compliant MSU server with data encryption at rest, dual-factor 
authentication, malware protection, 24 x 7 monitoring of event notification, and a dedicated and 
fully managed firewall with active intrusion detection and prevention and access tracking. 
Access to data will require use of appropriate passwords. 
 
REDCap is an electronic data capture software system supported by UMASS. Data in REDCap 
databases can be exported within the regulated environment to rSTATS or can be de-identified 
using the REDCap de-identification tool and exported via controlled CGI script interface to 
locations on the UMass network outside of the regulated environment. Within REDCap, IRB 
approved PIs and the CITI certified staff can edit records entered and generate PDF copies of 
individual forms. 
 
Data Security: 
• The project manager, data manager, and statistician will be responsible for receipt and 
transmission of data.  
• CIAS 3.0 is an NIH-funded Software-as-a-Service (Saas) platform for data collection and 
digital intervention authoring. CIAS is HIPAA compliant and protects participant data 
using encryption in transit and at rest. Data are accessed via a direct download from 
CIAS from within UMass. 
• Data will be transferred via secure file transfer or encrypted email, methods that are 
HIPAA compliant.  
• REDCap and CIAS are web-based systems. Downloaded data will be password protected 
and stored on secure UMass servers.  
• Data shall be retained at UMass for at least three years after the final report to the sponsor 
has been submitted, or the ending date of the project, whichever is later. In no case will 
the data be discarded or destroyed when it is known to be in use. Paper documents will be 
destroyed in a manner that leaves no possibility of reconstruction of information (e.g., 
secure document shredding). Electronic data will be permanently deleted.  
• No portable devices (e.g., laptops, thumb drives) will be used.  
• PIs and select CITI certified staff (including project manager, research assistants, data 
manager, statistician) who have an absolute need to access data will be able to access 
CIAS data and REDCap data.  

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Page 24 of 35 
 
• Access to REDCap and CIAS Data will be limited by defining user rights and roles. User 
rights and roles will be defined so that each staff member has the minimum access they 
need to complete their job.  
• Only required CITI certified staff will have access to server files storing data downloaded 
from REDCap and CIAS and access to research files will be granted so that each staff 
member has the minimum access they need to complete their job.  
• All staff will be CITI certified and will also receive training specific to the use of the 
REDCap and CIAS platforms. 
• All study computers will be password protected and connect to a secure network.  
• Access to computers storing study data will be limited by keeping office doors locked. 
Study data will not be accessible by computers in open spaces.  
• Information in consent forms will all be coded under a subject ID and kept on password 
protected data bases and in double locked files in the offices of research staff. 
• IP addresses will be deleted from the participant’s screening data when no longer needed 
(i.e., when study enrollment is complete). Unnecessary eligibility data will be deleted 
from those who do not qualify after ineligibility is determined. Remaining identifiers will 
be permanently deleted after the final report to the sponsor has been completed.  
• A certificate of confidentiality is automatically deemed to be issued to this NIH-funded 
study.  
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Participants will consent and enroll in the study using standard procedures for research with 
individuals recruited remotely from perinatal settings. All research activities will be conducted in 
as private a setting as possible. Prospective participants will complete an eligibility survey and, if 
eligible, will participate in an informed consent process which includes an explanation of the 
study protocol, the time points for follow-up, and potential risks and benefits related to study 
participation. Study staff will address any questions, and individuals will be encouraged to take 
time to think about participation in the study prior to consenting. All participants will receive a 
copy of the signed consent document. 
 
Possible distress will be noted clearly in the informed consent information sheet, which will also 
indicate that a referral for counseling is available from the RA. Participants may discontinue an 
interview or skip questions if they feel uncomfortable answering. Information will be coded 
under a subject ID and kept on password protected data bases and in double locked files in the 
offices of research staff. Data will not be shared with anyone outside the research team except in 
emergency situations (threat to self/others) and/or as required by law. 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
We will not provide compensation for injury but will arrange for additional mental health care if 
needed. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
Participants will pay for cell phone and texting service. We will assist individuals who are 
economically challenged and cannot afford these costs. 
 

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30. CONSENT PROCESS 
Once identified as potentially eligible, study staff will contact each potential participant to see if 
they are interested in consenting for the study. The full trial consent will be presented 
electronically with study staff on the phone and available to answer questions. When study staff 
connects with participants by phone, they will review the content of the consent form. 
Participation will proceed only if individuals provide written informed consent via e-signature. 
This functionality is available in the Computerized Intervention Authorizing System, Version 3 
(CIAS 3.0). All participants will receive a signed copy of these documents for their records.  
 
We will ensure that all study staff are familiar with and will follow HRP-090 – SOP – Informed 
Consent Process for Research. See # 27 for provisions to protect the privacy interests of 
subjects.  
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Consent will be documented in writing using HIPAA compliant CIAS 3.0. Participants will 
complete this after reviewing the consent form and will receive a copy of the signed consent 
form.  
 
32. DRUGS OR DEVICES 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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