Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations
Phase: NA
Conditions: Perinatal Depression
Sponsor: University of Utah

Official Title: Randomized Trial of Telehealth Group Intervention to Reduce Perinatal  
Depressive Symptoms in Diverse Populations 
 
NCT Number: NCT03932760 
 
Document Date: 11/17/2022 

Protocol Summary (ERICA) 
 
IRB_00113917 
Page 1 of 13 
 
IRB Approval 11/17/2022 
 
 
Randomized trial of telehealth group intervention to 
reduce perinatal depressive symptoms in diverse and 
rural populations 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
11/17/2022 
University of 
Utah IRB #: 
IRB_00113917 
Sponsor: NIH NATIONAL INSTITUTE OF NURSING RSRCH 
  
Principal 
Investigator: 
Gwen Latendresse 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah 
Gwen Latendresse 
 
Kristen Weissinger 
 
Kritzianel Merced-Morales 
 
Eli Iacob 
 
Ryoko Pentecost 
 
Alexandra Rivas 
 
Sara Simonsen 
 
Marcela Smid 
 
Xiaoming Sheng 
 
Marisol Jones 
 
Marcia Williams 
 
Ellois Bailey 
 
Heather Williamson 
 
RWINA BALTO 
 
Naomi Flake 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

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Background and Introduction 
 
Perinatal depression occurs in 12%–15% of pregnant and postpartum women and is associated 
with adverse outcomes for mother, baby, and family, including preterm birth, low 
birth  weight, and impaired cognitive development of the child (Ko, Rockhill,Tong, Morrow, 
& Farr, 2017; Martin, Hamilton, Osterman, Curtin, & Matthews, 2015; Bonari et al., 2004; 
Deave, Heron, Evans, & Emond, 2008) Early breastfeeding cessation and reduced ability to 
parent are also well-documented consequences (Bonari et al., 2004). Nonpharmacological 
therapies, such as cognitive behavioral therapy (CBT) and mindfulness-based practices 
(MBP), are known to be as effective as antidepressants for mild to moderate depression, and 
many pregnant and breastfeeding women prefer not to take antidepressants (O'Connor, 
Rossom, Henninger, Groom, & Burda, 2016; O'Mahen & Flynn, 2008). However, limited 
access to and availability of mental health professionals are common barriers to services 
among women living in rural and low-resource communities (Alang, 2015; Bloom, Bullock, & 
Parsons, 2012). Lack of consideration for cultural and ethnic variation also creates an 
additional barrier for many women (for example, Hispanic) (O'Mahen & Flynn, 2008; Baker-
Ericzen et al., 2012; Goodman, Dimidjian, & Williams, 2013, The Health Resources and 
Service Administration [HRSA], 2012). Recommendations for universal screening for 
perinatal depression during pregnancy and 
postpartum have left many women and their providers searching for solutions to the current 
scarcity of resources available to women who screen positive. Telehealth is revolutionizing the 
delivery of healthcare services and is a promising platform for perinatal mental health care 
(HRSA, 2012). A telehealth approach will reduce barriers to access and can be tailored to 
deliver effective services regardless of geographic location (HRSA, 2012). Our pilot work 
demonstrated feasibility and acceptability of a group video conference intervention (VCI) to 
deliver nonpharmacological services (CBT and MBP) to women experiencing perinatal 
depressive symptoms (PDS) (Latendresse, Dorn, Ozawa-Kirk, & Allred, in review; 
Latendresse et al., in review). Our research team incorporated participant feedback into 
revising the VCI, including the use of a low-cost, easy-to-access Web-based platform and use 
of any electronic device (laptop, tablet, smartphone, or landline) to join facilitated VCI groups 
of six women. To build on our pilot work, we propose to evaluate the effectiveness of the VCI 
to reduce PDS and anxiety (a highly comorbid condition) by conducting a randomized 
controlled trial among women experiencing mild to moderate PDS, as measured by the 
Edinburgh Postnatal Depression Scale (EPDS).  
 
 
 
Purpose and Objectives 
 
The study will evaluate the effectiveness of a videoconference intervention (VCI) to reduce 
perinatal depression symptoms (PDS) and anxiety (a highly co-morbid condition) by 
conducting a randomized controlled trial among women experiencing mild to moderate PDS, 
as measured by the Edinburgh Postnatal Depression Scale (EPDS). Furthermore, we propose 
to evaluate differences in response to the VCI between subgroups of childbearing women; 
Hispanic and North European Descent populations, and rural and urban-dwelling.  

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Specific aims of the study include: 
Aim 1: Evaluate the effectiveness of a VCI to reduce PDS and anxiety, as measured by EPDS 
and Generalized Anxiety Disorder-7 Item (GAD-7) scores across pregnancy and the 
postpartum. Methods: Pregnant women of all gestational age up to 6 months postpartum (n = 
240) who screen positive for mild to moderate PDS (EPDS scores 9–20) will be randomly 
assigned to VCI or AC for eight weeks. Both groups will continue with standard care as 
directed by their primary/prenatal care providers. The EPDS and GAD-7 will be administered 
at three time points during pregnancy and at 2, 4, and 6 months postpartum. Hypothesis: 
Women participating in the VCI will have significantly lower post intervention EPDS and 
GAD-7 scores across pregnancy and postpartum than women in the AC group. 
Secondary Aim 1: Explore differences in the effectiveness of the VCI to reduce PDS and 
anxiety across women who enroll at different stages of their pregnancy or postpartum periods. 
Aim 2: Evaluate the interaction of the VCI with specific subgroups: ethnicity (Hispanic, North 
European descent), geographic location (rural, urban), and the outcome of PDS as measured by 
EPDS and GAD-7 scores across pregnancy and postpartum. We will oversample in Hispanic 
and rural populations to ensure sufficient representation from diverse groups. Hypothesis: 
Women will demonstrate differences in EPDS and GAD-7 scores across pregnancy and 
postpartum, dependent on their study group membership. 
Secondary Aim 2: Explore an additional subgroup analysis, namely between those who are 
and who are not taking medication at the time of screening. 
 
 
 
Study Population 
 
Age of Participants: 18+ 
 
Sample Size: 
At Utah: 
240  
All Centers: 
 
 
Inclusion Criteria: 
The study will include women 18 years of age and older who, at time of enrollment (1) have 
a viable pregnancy or have given birth within the previous 6 months, (2) have an Edinburgh 
Postnatal Depression Scale (EPDS) score of 9–20; (3) are English- or Spanish-speaking; and 
(4) are attending a collaborating prenatal or public health clinic associated with the 
University of Utah or Utah Department of Health. 
 
 
Exclusion Criteria: 
The study will exclude women who, at time of enrollment (1) have an EPDS score <9 or 
>20; (2) have a current diagnosis of a serious mental illness, such as psychosis, 

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schizophrenia, bipolar disorder, severe depression, or suicidality; or (3) have begun taking 
or changed dosage of any medication for a mental health condition within the past 6 weeks 
 
 
Design  
 
Randomized Trial 
 
 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
VCI/AC Sessions 
Each study clinical site has implemented a universal electronic screening for perinatal 
depression, which ensures that all women receiving services at all study facilities are screened 
during pregnancy and postpartum. In addition, staff at the collaborating sites inform women 
about the study by way of flyer or direct interaction. No one is involved in consenting 
participants or in delivering the interventions. Flyers could be handed out to potential 
participants or would be available at study sites (e.g., on walls with site's approval). Handing 
out flyers would help patients think about participating in the study for those who cannot make 
a decision at the study site. Screening includes the Edinburgh Postnatal Depression Scale 
(EPDS) and is self-completed by patients at the time of a clinical office visit. Patients 
complete the screening in the clinic using an electronic device (tablet, computer, or their own 
Smartphone) as soon as possible when they come in. Screening results are integrated into the 
Electronic Health Record (EHR) and/or electronic database managed by the University of 
Utah. Results are immediately available electronically to the patient and her healthcare 
provider for evaluation, management and/or referral. These electronic screening results are 
also available to study staff for the purposes of identifying potential study participants, i.e. 
positive screening results (greater than 9 on EPDS). The electronic screening process 
conveniently includes an item that allows patients to indicate their interest in receiving 
additional information and/or agreement to be contacted as a potential research participant. 
Those who agree will be contacted by study staff by phone or email. Alternatively, a patient 
can contact the study staff herself. Women who screen positive, are determined eligible to 
participate by study staff, and are interested in participating are contacted by study staff to 
discuss the study and complete the informed consent process. Informed consent is completed 
by telephone or video conference platform. The consent form is sent to potential participants 
via REDCap email or the U.S. Postal Service, if there is no email address. Eligibility is 
confirmed through EHR, particularly for confirming gestational age, maternal age, medication 
status, mental health diagnoses, etc. All potential participants are screened for suicidal and 
homicidal ideation, and if either are present the individual is immediately referred to a mental 
health professional for further evaluation, and to determine appropriateness for participating in 
the study. 

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Social media (Twitter, Instagram, and Facebook) will also be used to recruit and inform 
potential participants about the study. Short video clips will be played on clinic monitor 
screens with information about the study and small study cards will be available to take home 
if interested in the study. The study staff will also utilize community events to raise awareness 
of the study.  
Radio advertisements will be used to recruit participants for the study. This will specifically be 
relevant for the Latina population, based on feedback from community partners. 
QR code/survey link will be used to recruit participants by allowing them to take the screening 
on their own and give their contact information if they are interested in learning more about 
the study. 
We will coordinate with members of the data science service at the University of Utah to 
identify patients who (1) have agreed to be contacted regarding research studies and (2) meet 
our inclusion criteria.  Members of the data science service will share a report with the 
research team that includes patient information, such as: name, age, sex, ethnicity, 
pregnancy/postpartum status, email, and mobile phone number.  The research team will use 
this information to send study invitations via email (and printed mail, if needed) to potential 
participants.  These emails will include information for easy-to-follow steps for opting out of 
the study.  Individuals who elect to opt-out of the study will be removed from future 
communication and their information will be removed from study data.  Anonymous 
demographic data from opt-out individuals may be retained for the purposes of describing the 
demographics of the total population considered for this study.  Individuals who do not elect to 
opt-out will be contacted again (up to three times) by the research team, either via email, 
phone call, text, or print mail. 
Focus Groups 
Participants for the pre-intervention Latina focus groups will be recruited via word of mouth, 
community events, social media, video clips in clinics, and recruitment flyers, utilizing study 
staff's contacts within the Latina community. These same methods will be used to recruit 
participants for the main study arm. 
Participants for the additional focus groups related to perceptions of mental health and 
recruitment will be recruited through the Community Collaboration & Engagement Team 
(CCET) at the University of Utah. An informational recruitment flyer will inform potential 
participants of the opportunity to participate. Note: American Indian populations will not be 
recruited without proper approval from appropriate groups 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Telephone or video conference at a time that is convenient to the woman and research team 
member. 
 
Description of the consent process(es), including the timing of consent:  

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Women who screen positive (EPDS score of 9-20) as part of the universal perinatal depression 
screening program, and also indicate an interest in the study, will be contacted by study 
personnel by phone or email. Eligible and interested women receive a study flyer and a 
consent form by regular USPS mail and/or email attachment. The informed consent process is 
completed by telephone or videoconference at a time that is convenient to the woman and 
research team member. A copy of the signed consent form is then exchanged by email 
attachment or USPS mail. 
 
Procedures: 
Recruitment 
We will coordinate with members of the data science service at the University of Utah to 
identify patients who (1) have agreed to be contacted regarding research studies and (2) meet 
our inclusion criteria.  Members of the data science service will share a report with the 
research team that includes patient information, such as: name, age, sex, ethnicity, 
pregnancy/postpartum status, email, and mobile phone number.  The research team will use 
this information to send study invitations via email (and printed mail, if needed) to potential 
participants.  These emails will include information for easy-to-follow steps for opting out of 
the study.  Individuals who elect to opt-out of the study will be removed from future 
communication and their information will be removed from study data.  Anonymous 
demographic data from opt-out individuals may be retained for the purposes of describing the 
demographics of the total population considered for this study.  Individuals who do not elect 
to opt-out will be contacted again by the research team (up to three times), either via email, 
phone call, text, or print mail. 
Each study clinical site has implemented a universal electronic screening for perinatal 
depression, which ensures that all women receiving services at all study facilities are screened 
during pregnancy and postpartum. In addition, staff at the collaborating sites inform women 
about the study by way of flyer or direct interaction. No one is involved in consenting 
participants or in delivering the interventions. Flyers could be handed out to potential 
participants or would be available at study sites (e.g., on walls with site's approval). Handing 
out flyers would help patients think about participating in the study for those who cannot 
make a decision at the study site. Alternatively, a patient can contact the study staff herself. 
Social media (Twitter, Instagram, and Facebook) will also be used to recruit and inform 
potential participants about the study. Short video clips will be played on clinic monitor 
screens with information about the study and small study cards will be available to take home 
if interested in the study. The study staff will also utilize community events to raise awareness 
of the study.  
Radio advertisements will be used to recruit participants for the study. This will specifically be 
relevant for the Latina population, based on feedback from community partners. 
Enrollment 
Women who have indicated an interest in participating in the study will be contacted by a 
study team member by text, telephone and/or email to discuss the study and complete the 

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informed consent process. During that time, eligibility is confirmed through EHR (please see 
the #4b recruitment/participant identification process), particularly for confirming gestational 
age, maternal age, medication status, mental health diagnoses, etc. All potential participants 
are screened for suicidal and homicidal ideation, and if either are present the individual is 
immediately referred to a mental health professional for further evaluation, and to determine 
appropriateness for participating in the study.  
Latina Focus Groups 
Those enrolled in the pre-intervention focus groups will participate in a 1-hour focus group. 
Participants will give feedback on how to tailor the intervention and control group content to 
best serve Latina participants. There will be a total of 2 Latina groups with up to 10 
participants per group.  
Perceptions of Mental Health and Recruitment Focus Groups 
 
Those enrolled will participate in a 2-hour virtual focus group. These women will fill out a 
short demographic survey online. Participants will give feedback about experiences of 
participating in research about and treatment of maternal mental health via telehealth. There 
will be three focus groups with up to 15 participants each, the first focused on rural 
Hispanic/Latina women, the second focused on the general rural population, and the third on 
the rural American Indian/Alaska Native population. These women will receive a $75 gift card 
to Amazon or a local grocery store electronically or by mail. Note: American Indian 
populations will not be recruited or enrolled without proper approval from appropriate groups 
Stratified Randomization Into Study Groups 
After consenting to participate, women will be assigned by computer-generated randomization 
by two different stratifications (Hispanic/NED and Urban/Rural) to one of two study groups: 
Videoconference intervention (VCI) or Attention Control. Both groups will continue with 
standard of care as directed by their prenatal care provider. After randomization, the 
participant will receive study information pertinent to her specific study group, by mailed hard 
copy and/or emailed electronic document. Enrollment and randomization will continue until 
the following enrollment goals are met. 
VCI Participants 
A study team member will contact the participant by telephone and/or email to determine 
which group start date works best for her and to schedule a time for technology testing and 
instruction. 
All Participants: Technology Literacy 
Prior to the start date of the first VCI or AC session, each participant will meet with study 
staff for the purpose of (1) assessing the participant’s technology literacy, (2) testing the 
participant’s Internet connection and chosen electronic device, and (3) providing instruction 
and demonstration for connecting to the videoconference platform (Acano). More than one 
meeting may be required and will include meeting via Acano and troubleshooting directly 

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with the participant. After this is completed to the satisfaction of the participant and study 
staff, the next step will be to schedule the participant to meet with the VCI group facilitator 
via Acano. 
Individual Participant Acano Meeting with VCI or AC Group Facilitator 
Prior to the first VCI or AC group session, participants will be scheduled for a 30-minute 
Acano or phone meeting with the individual who will be facilitating the participant’s assigned 
group. The purpose of the meeting is for the facilitator to (1) establish a one-on-one 
connection with the participant prior to the start of the group, (2) repeat the technology check 
with the participant, and (3) identify any concerns that would disqualify the woman from 
study participation (e.g., serious mental health conditions, including severe depression or 
suicidal ideation that may need immediate referral for more intensive therapy and/or 
pharmacotherapy). 
Group VCI Sessions 
Using the UTN-supported Acano platform, women will attend weekly, 1-hour 
videoconference sessions with 4–5 other participants (maximum n = 6), for a total of 10 
sessions: one initial session for getting acquainted with one another and the program, eight 
sessions for engagement in the VCI intervention, and a follow-up “reunion” 6–8 weeks after 
the last session. Members of the Latina community will be enrolled in study groups that will 
include 15 minutes of extra mental health content, based on recommendations from the focus 
groups done in the community and their needs (actual intervention content will not be altered, 
just additional mental health background will be included). Participants will attend each 
session using their own Internet connection and electronic device (computer, laptop, electronic 
tablet, smart phone) to connect to Acano. Alternatively, participants can connect via the 
Internet without video, or as a last resort can simply call in by telephone landline or basic 
mobile phone. The intervention is a standardized and manualized program called UPLIFT 
(Using Practice and Learning to Increase Favorable Thoughts), developed and evaluated by 
Dr. Thompson. UPLIFT is an 8-week group intervention based on CBT and MBP, therapies 
with demonstrated effectiveness in the prevention and treatment of depression. Originally 
developed as an online and telephone-based approach, we have adapted and piloted the 
program for videoconference use in a pregnant population.12,13 Our revised telehealth 
approach has several advantages over conventional in-person therapies, including (1) 
improved accessibility to therapy among working, low-income, and rural-dwelling mothers, 
and those with time, childcare, and transportation barriers; (2) the ability to develop a 
supportive community among other mothers of similar risk status and life circumstances; (3) 
the ability for women to build an effective skill set for the prevention and treatment of 
depression that can last a lifetime; (4) the addition of nonverbal communication between 
group participants and the facilitator when videoconferencing is used; and (5) sufficient time 
to acquire and practice Mindfulness-Based Cognitive Behavioral Therapy skills early in 
pregnancy, prior to baby’s arrival and the postpartum period, when the risk of depression is 
highest. After the 8-week intervention, a cohort “reunion” will be held approximately 6–8 
weeks after the last session. The approach just described was developed based on the strong 
recommendations of participants in our pilot studies, including the initial pre-UPLIFT meeting 

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and post-UPLIFT “reunion.” Women will begin VCI sessions no later than 20-weeks 
gestational age, with completion no later than 36 weeks gestational age. 
UPLIFT Manualized Program 
All sessions will be facilitated by a credentialed mental health professional specifically trained 
in the UPLIFT program. Each 1-hour session will include a check-in, instruction, skill 
building, and discussion. Latina participants will have 15 minutes extra content to discuss 
mental health more in depth as part of the intervention group, based on feedback we received, 
which will not alter the actual intervention content itself.The facilitator will use an UPLIFT 
manual as the outline for each specific session of the 8-week series. Each participant will also 
receive the UPLIFT manual (print and/or electronic document), which contains details and 
resources for each session. Sessions will focus on increasing knowledge about depression and 
pregnancy, CBT, and MBP. Participants will learn and practice skills related to CBT and 
mindfulness, and engage in discussions and group exercises for each session’s main topic. 
Topics include thought monitoring, identifying distortions in thoughts, self-esteem, 
identification of problems, goal setting, and achieving support. Exercises include relaxation; 
body scan; progressive muscle relaxation; attention to breath, sights, and sounds; and 
meditation. Each week, participants will be provided with recommendations for between-
session practices, which will be discussed at the beginning of the next class. 
Attention Control (AC) Group 
Women who are randomized into the AC will participate in an 10-week education program 
delivered by group videoconference platform supported by UTN. The education program is 
manualized and designed to enhance participant knowledge related to pregnancy, childbirth, 
newborn care, and feeding, or parenting young babies. All participants in the AC group will 
receive a mailed hard copy and/or emailed electronic packet (participant’s choice) that 
includes topical education, which includes information about perinatal depression and mood 
disorders (e.g., anxiety and obsessive-compulsive disorder, postpartum psychosis), 
interpretation of EPDS scores, common therapies for PD, local resources for obtaining 
therapies, and encouragement to discuss their EPDS scores with their prenatal care provider. 
This approach provides a control group that reduces bias as much as possible, and most 
closely reflects an optimal care level that includes screening and patient education for all 
pregnant and postpartum women. 
Data Collection 
Data collected for this study will come from the following sources: Clinical universal 
screening records (the EPDS in the electronic health record [EHR]), participant-completed 
study questionnaires, audio-recorded VCI sessions, and participant focus groups. EPDS is a 
validated survey. 
Clinical Screening Records 
Screening that is completed in the clinical setting as part of their routine clinical care is 
immediately communicated to and addressed by clinical providers at the time of the prenatal 
or postpartum visit. EPDS and GAD-7 measurements completed periodically and 

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electronically by enrolled participants as part of the study (not as part of their routine clinical 
care) are evaluated and addressed by study personnel within 24-48 hours of completion. 
Participants are contacted directly by study personnel for scores >20 on the EPDS, or if the 
participant indicates thoughts of harm to self. Furthermore, the EPDS and GAD-7 are 
electronically scored, interpreted, and communicated to the participant immediately. At that 
same time, participants also receive electronic resources, including crisis and suicide 
prevention hot line phone numbers, website links, and study personnel contact information. 
Participant-Completed Questionnaires 
Questionnaires will be completed by participants via a secure, Web-based data management 
system (REDCap). Women in all study groups will receive an emailed link to the 
questionnaire. Study questionnaires are to be completed at six time points: T1 = enrollment; 
T2 = after group session 9; T3 = 2 months post session 9 T4 = 4 months post session 9; T5=6 
months post session 9; T6= 8 months post session 9. In addition to participant demographics, 
questionnaires will include the EPDS as a measure of the primary outcome of interest: 
depressive symptoms, as well as the GAD-7 as a measure of comorbid anxiety (GAD-7 is a 
validated survey). To document the standard of care that all participants receive during study 
participation, the questionnaire at all six-time points also asks participants to report whether 
they (1) received a diagnosis of depression, anxiety, or other mental health condition; (2) were 
prescribed or initiated any medication for depression or anxiety; (3) were referred to and/or 
engaged in mental health services; and/or (4) have engaged in any type of nonpharmacological 
therapies for depression/anxiety during the study. If a participant does not have an email 
address, study staff will assist her to establish and access a free email address. All participants 
will receive instruction on how to access and complete the study questionnaires. The entire 
questionnaire takes approximately 15 minutes to complete. Participants receive $20 for each 
questionnaire completed. 
Focus Groups 
Participants will be invited to attend one focus group interview with 6-8 other participants, 
again using the UTN-supported videoconference platform, and within 8 weeks of completing 
the last group session (VCI or AC). The purpose of the focus group is to collect data directly 
from participants regarding satisfaction with the program, e.g. program content, 
videoconference platform, development of community, support, suggestions for improvement, 
etc. Participants receive $20 for attending the focus group. 
Digital Recording of Sessions and Focus Groups 
To document and evaluate intervention and attention control group fidelity and 
standardization, and for future qualitative data analysis, we will record all focus groups, and a 
random selection of sessions. The Acano platform has recording capability built into the Web-
based program, and is managed by UTN. The recording is unobtrusive and runs seamlessly in 
the background, unnoticed by facilitators or participants. Acano is a secure, HIPAA-compliant 
program. All participants are informed that sessions may be recorded, and this is also part of 
the informed consent process and consent document. The digital recordings are stored 
securely in a shared, password-protected file system, backed up continuously, and protected 

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by the UTN and U of U firewalls. Recordings are transcribed by a professional 
transcriptionist, de-identified, and uploaded to a secure, shared file on the U of U protected 
electronic environment. 
Data Analysis 
We will use multilevel generalized mixed modeling under an intent-to-treat approach to 
compare the outcome measures of EPDS and GAD-7 between group 1 (VCI) and Group 2 
(AC) at six-time points during pregnancy and postpartum. This is an appropriate statistical 
approach for the described RCT protocol. Sensitivity analysis was conducted with G-Power 
3.1. We used RMANOVA with 6 total measures as a conservative power analysis for our 
mixed-effects model. The sample is powered for the fixed effect of Intervention X Time. For 
study aim 1: Using RMANOVA with alpha = 0.5, 6 total measures, 0.3 for correlation 
between repeated measures, and a sample size of 192 total participants gives greater than 90 
percent power to detect an effect size of 0.1, which is a net decrease in EPDS and GAD-7 of 
roughly 1 point decrease per time point, assuming a standard deviation of 5. For study aim 2: 
For the stratified samples of urban/rural or Hispanic/NED, we have greater than 80 percent 
power to detect the same Intervention X Time effect size of 0.1. 
Dissemination Plan 
Sharing of data generated by this project is an essential part of our proposed activities and will 
be carried out in several different ways. We are interested in our results being available to the 
community of scientists interested in maternal-fetal medicine, health communication, and 
ethical and social implications of population-level genetic screening. We will register this 
project with clinicaltrials.gov upon notification of award, in accordance with NIH policy. The 
Project Administrator will be expected to update the clinicaltrials.gov listing every 6 months, 
or as needed during recruitment. 
We also plan to present our findings at conferences and publish the findings.  
  
 
 
Procedures performed for research purposes only:  
Group Videoconference Intervention Sessions (UPLIFT Manualized Program): All session
will be facilitated by a credentialed mental health professional specifically trained in the 
UPLIFT program. Each 1-hour session will include a check-in, instruction, skill building, 
discussion. The facilitator will use an UPLIFT manual as the outline for each specific sess
of the 8-week series. Each participant will also receive the UPLIFT manual (print and/or 
electronic document), which contains details and resources for each session. Sessions will 
focus on increasing knowledge about depression and pregnancy, CBT, and MBP. Participa
will learn and practice skills related to CBT and mindfulness, and engage in discussions an
group exercises for each session’s main topic. Topics include thought monitoring, identify
distortions in thoughts, self-esteem, identification of problems, goal setting, and achieving
support. Exercises include relaxation; body scan; progressive muscle relaxation; attention 
breath, sights, and sounds; and meditation. Each week, participants will be provided with 

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recommendations for between-session practices, which will be discussed at the beginning of 
the next class. 
Attention Control Group (delivered by group videoconference platform):The education 
program for women >=32 weeks gestation is manualized and designed to enhance participant 
knowledge related to pregnancy, childbirth, newborn care, and feeding. The education 
program for women >32 weeks gestation is designed to enhance knowledge related to 
parenting and young babies. All participants in the AC groups will receive a mailed hard copy 
and/or emailed electronic packet (participant’s choice) that includes topical education, which 
will also include information about perinatal depression and mood disorders (e.g., anxiety and 
obsessive-compulsive disorder, postpartum psychosis), interpretation of EPDS scores, 
common therapies for PD, local resources for obtaining therapies, and encouragement to 
discuss their EPDS scores with their prenatal care provider. 
Participant-Completed Questionnaires. Questionnaires will be completed by participants via a 
secure, Web-based data management system (REDCap). Women in all study groups will 
receive an emailed link to the questionnaire. Study questionnaires are to be completed at six 
time points: T1 = enrollment; T2 = post intervention ; T3 = 2 months post intervention GA; T4 
= 4 months post intervention; T5= 6 months post intervention; T6= 8 months post 
intervention. In addition to participant demographics, questionnaires will include the EPDS as 
a measure of the primary outcome of interest: depressive symptoms, as well as the GAD-7 as a 
measure of comorbid anxiety. To document the standard of care that all participants receive 
during study participation, the questionnaire at all six-time points also asks participants to 
report whether they (1) received a diagnosis of depression, anxiety, or other mental health 
condition; (2) were prescribed or initiated any medication for depression or anxiety; (3) were 
referred to and/or engaged in mental health services; and/or (4) have engaged in any type of 
nonpharmacological therapies for depression/anxiety during the study. If a participant does not 
have an email address, study staff will assist her to establish and access a free email address. 
All participants will receive instruction on how to access and complete the study 
questionnaires. The entire questionnaire takes approximately 15 minutes to complete. 
Participants receive $20 for each questionnaire completed. 
Focus Groups 
Participants will be invited to attend one focus group interview with 6-8 other participants, 
again using the UTN-supported videoconference platform, and within 8 weeks of completing 
the last group session (VCI or AC). The purpose of the focus group is to collect data directly 
from participants regarding satisfaction with the program, e.g. program content, 
videoconference platform, development of community, support, suggestions for improvement, 
etc. Participants receive $20 for attending the focus group. A questionnaire with the same 
questions asked in the two randomized groups will be completed by participants via a secure, 
web-based data management system (REDCap) upon completion of the focus group or 
completed on a paper document kept in a secure locked cabinet in the College of Nursing until 
data can be entered into REDCap.. 
 
 

Protocol Summary (ERICA) 
 
IRB_00113917 
Page 13 of 13 
 
IRB Approval 11/17/2022 
 
Statistical Methods, Data Analysis and Interpretation 
 
Enrollment and randomization will continue until the following enrollment goals are met: 
Urban Latinas = 60 (n = 30 VCI; 30 AC); Rural Latinas = 60 (n = 30 VCI; 30 AC); Urban, 
North European-descent (NED) = 60 (n = 30 VCI; 30 AC); Rural NED = 60 (n = 30 VCI; 30 
AC), for a total of 240 participants. 
Data Analysis: 
We will compare demographics, partum group, and medications between groups (χ2) to 
document the results of our randomization process. We will further document and test for 
differences in frequency and means in groups related to additional study-related variables. 
Examples include dose of participation and birth complications or pre-term deliveries. We will 
explore the addition of these variables in our analytical models. 
We will utilize multilevel generalized mixed modeling (via SPSS and R) under an intent-to-
treat (ITT) approach to compare the outcome measures of EPDS and GAD-7 between Group 1 
(VCI) and Group 2 (AC) at up to six time points. To assess whether we will need to nest 
participants within clusters (Level 3, group-level) given that the intervention/control are 
administered in groups, we will conduct an analysis that adds an additional level (nesting 
participants within clusters) to our proposed model and calculate the model’s ICC.As an 
exploratory analysis, for both aims, we will add the fixed effect of baby’s sex to final models 
and report results.