Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
Phase: NA
Conditions: Perinatal Depression
Sponsor: Mount Sinai Hospital, Canada

1 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Scaling Up Maternal Mental healthcare by Increasing access to Treatment 
(SUMMIT): A study protocol for perinatal depression and anxiety* 
 
 
 
Version 20.0 
 
 
Funding.  This study is funded as a Pragmatic Clinical Study (PCS) by the Patient-Centered 
Outcomes Research Institute (PCORI), PCS-2018C1-10621.  
 
 
Trial Sponsor.  
Sinai Health  
Contact Name:  Daisy R. Singla 
600 University Ave., #914A  
Toronto, Ontario  
M5G 1X5   
Canada 
Telephone:  
(416) 562-4438 
Email:   
daisy.singla@utoronto.ca  
 
 
 
 
 
 
 
 
 
 
 
 
 
* This protocol includes details of economic evaluation, which was added for a substudy not 
funded by PCORI  
 

2 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
TABLE OF CONTENTS 
 
TABLE 1. LIST OF ABBREVIATIONS 
5 
TABLE 3. STUDY MANAGEMENT AND COMMITTEES. 
8 
TABLE 4. PROTOCOL SUMMARY TABLE. 
9 
1 
10 
1.1.  BACKGROUND 
10 
1.1.1.  Scalable Innovations 
10 
1.1.1.2.  Non-specialist providers. 
10 
1.1.1.3.  Telemedicine. 
10 
1.1.2.  Why Behavioural Activation? 
11 
1.2. RATIONALE 
11 
1.3 POTENTIAL RISK AND BENEFITS 
11 
1.3.1. Potential Risks 
11 
1.3.1.1. Inconvenience. 
11 
1.3.1.2. Psychological risks associated with assessment. 
11 
1.3.1.3. Psychological risks associated with treatment or training. 
12 
1.3.1.4. Physical Harm. 
12 
1.3.2 Potential Benefits 
12 
1.4. OBJECTIVES. 
13 
1.4.1. Primary Objectives 
13 
1.4.2. Secondary Objectives 
13 
1.5.  HYPOTHESES 
13 
1.6.  STUDY DESIGN 
13 
2 
14 
2.1.  PARTICIPANTS AND SETTING. 
14 
TABLE 5. INCLUSION AND EXCLUSION CRITERIA 
14 
FIGURE 1: STUDY FLOW CHART 
16 
2.2.  TREATMENT AND INTERVENTION ARMS 
16 
2.2.1.  Treatment. 
16 
2.2.2. Treatment indicators. 
16 
2.2.3. Intervention Arms. 
17 
FIGURE 2. INTERVENTION ARMS 
17 
2.2.3.1 Telemedicine vs. In-Person. 
17 
2.2.3.2 Non-Specialists vs. Specialists. 
17 
FIGURE 3. UPDATED RANDOMIZATION STRATEGY 
18 
2.3 NON-SPECIALISTS: RECRUITMENT, TRAINING, SUPERVISION AND SELECTION 
18 
2.3.1 Recruitment 
18 
2.3.2. Training & Competency Tests. 
18 
2.3.3. Supervision. 
19 
2.3.4. Selection. 
19 
2.4 SPECIALISTS. 
19 

3 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
2.5.  OUTCOMES AND TIMING OF ASSESSMENTS. 
20 
TABLE 6.  OUTCOMES 
20 
2.6. SAMPLE SIZE 
22 
2.7.  SCREENING, RECRUITMENT, AND CONSENT 
22 
FIGURE 4: RECRUITMENT PROCESS 
25 
2.7.2. Qualitative Interviews. 
25 
2.7.2.1. Phase 1. 
25 
2.7.2.2. Phase 2 (May 2020 to Mar 2024). 
25 
2.8.  RANDOMIZATION 
27 
2.9. 
27 
2.10.1. Economic-related data. 
27 
2.10.2. Service use. 
27 
2.10.3. Costs. 
28 
3 
28 
3.1.  DATA COLLECTION 
28 
3.1.2.  Qualitative Data. 
28 
3.1.2.1. Phase 1. 
28 
3.1.2.2. Phase 2. 
28 
3.2.  DROP OUT AND FOLLOW-UP STRATEGIES 
29 
3.3. PARTICIPANT WITHDRAWAL 
30 
3.4.  DATA MANAGEMENT 
30 
3.4.1.  Quantitative Data. 
30 
3.4.2.  Qualitative Data. 
30 
3.4.2.1. Phase 1. 
30 
3.4.2.2. Phase 2. 
31 
3.4.3. Audio-Recordings. 
31 
3.5.  STATISTICAL ANALYSES 
31 
3.5.1.  Primary Analysis. 
31 
3.5.2.  Secondary Analysis. 
32 
3.5.3.  Subgroup Analyses. 
33 
3.5.3.1.  Clinical Severity. 
33 
3.5.3.2.  Perinatal Period. 
33 
3.5.3.3.  Treatment Providers. 
33 
3.5.4.  Qualitative Analysis. 
34 
3.5.5 Economic Evaluation Analysis. 
34 
3.5.6.  Missing Data. 
35 
3.6.  DATA RETENTION 
35 
4     MONITORING 
35 
4.1.  DATA AND SAFETY MONITORING BOARD 
35 
4.2.  REPORTING 
36 
4.3.  SERIOUS ADVERSE EVENTS 
36 
4.4.  SAFETY PROTOCOLS 
36 
5  
38 
5.1.  RESEARCH ETHICS APPROVAL 
38 

4 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
5.2.  PROTOCOL AMENDMENTS 
38 
5.3.  CONFIDENTIALITY 
39 
5.4.  DECLARATION OF INTERESTS 
39 
5.5.  DATA MANAGEMENT 
39 
5.6    TESTIMONIALS 
39 
6   REFERENCES 
40 

5 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Table 1. List of Abbreviations  
Abbreviation 
Explanation 
ADM 
Antidepressant Medication 
AE 
Adverse Event 
AUDIT 
Alcohol Use and Disorders Identification Test 
BA 
Behavioural Activation 
CAMH 
Centre for Addiction and Mental Health 
CBT  
Cognitive Behavioural Therapy 
CEAC 
Cost-Effectiveness Acceptability Curve 
CSQ-8 
Client Satisfaction Questionnaire-8 
CTO 
Clinical Trials Ontario 
DAST 
Drug Abuse Screening Test 
DSMB 
Data and Safety Monitoring Board 
EPDS  
Edinburgh Postnatal Depression Scale 
EQ-5D-5L 
EuroQol 5 Dimension 5 Level 
GAD-7  
Generalized Anxiety Disorder-7 Scale 
HAP 
Health Activity Program 
HIC  
High-income countries 
HIPAA 
Health Insurance Portability and Accountability Act 
HTE 
Heterogeneity of Treatment Effects  
ICER 
ICES 
Incremental Cost-Effectiveness Ratio 
Institute for Clinical Evaluative Sciences 
IRB 
Institutional Review Board (US) 
LMIC 
Low and middle-income countries 
MINI 
Mini International Neuropsychiatric Interview 
NSP  
Non-specialist provider 
OB 
Obstetrician 
PAI 
Personalized Advantage Index 
PCL-6 
Abbreviated PTSD Checklist 
PCORI 
Patient-Centered Outcomes Research Institute 
PHIPA 
Personal Health Information Protection Act  
PHQ-9 
Patient Health Questionnaire-9 
PT  
Psychological Treatment 
Q-HAP 
Quality of Healthy Activity Program 
RA  
Research Assistant 
REB  
Research Ethics Board (Canada) 
SAE 
Serious Adverse Event 
SAN 
Storage Area Network 
SAS 
Statistical Analysis System 
SD 
Standard Deviation 
SH  
Sinai Health  
SHSC 
Sunnybrook Health Sciences Centre 
SMH 
St. Michael’s Hospital 
TIC 
Trial Investigator Committee 
TMC 
Trial Management Committee 
TSC  
Trial Steering Committee 
TSM  
Trial Steering Management 

6 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
QALY 
Quality-Adjusted Life Year 
UK 
United Kingdom 
UNC 
University of North Carolina 
USA/US 
United States of America 
USD 
U.S. Dollar 
UofT 
University of Toronto 
WAI-SR 
Working Alliance Inventory-Short Revise 
WCH  
Women’s College Hospital 
WHODAS 
World Health Organization Disability Assessment Schedule 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Table 2.  Investigators, Roles and Responsibilities 
 
Name 
Role 
Affiliation 
Contact Information 
Daisy Radha Singla, PhD 
Study PI, Site PI of 
SHS and CAMH  
SHS, CAMH, UofT daisy.singla@utoronto.ca 
Samantha Meltzer-Brody, MD, 
FRCPC 
Co-PI, Site PI of UNC UNC 
samantha_meltzer-
brody@med.unc.edu 
Richard Silver, MD 
Co-I, Site PI of 
NorthShore  
NorthShore, 
UChicago 
rsilver@northshore.org 
 
Simone Vigod, MD, FRCPC 
Co-I, Site PI of WCH  WCH, UofT 
simone.vigod@wchospital.ca 
Cindy-Lee Dennis, PhD 
Co-I, Site PI of SMH  SMH, UofT 
cindylee.dennis@utoronto.ca 
UToronto 
Paula Ravitz, MD, FRCPC 
Co-I, Clinical Lead 
SHS, UofT 
paula.ravitz@sinaihealthsystem.ca 
Ariel Dalfen, MD, FRCPC 
Co-I, Trial Psychiatrist SHS, UofT 
ariel.dalfen@utoronto.ca 
Alex Kiss, PhD 
Co-I, Biostatistician 
SHSC, UofT 
alex.kiss@ices.on.ca 
Andrea Lawson, PhD 
Co-I, Mental Health 
Researcher 
CAMH, UofT 
andrea.lawson@camh.ca 
Claire de Oliveira, PhD 
Health Economist 
CAMH, UofT 
claire.deoliveira@camh.ca 
University of North Carolina 
Crystal Schiller, PhD 
Co-I, Clinical Lead 
UNC 
crystal_schiller@med.unc.edu 
Alison Stuebe, MD 
Co-I, Maternal-Fetal 
Medicine 
UNC 
astuebe@med.unc.edu 
 
Mae Lynn Reyes-Rodriguez, PhD 
Co-I, Cultural 
Competency Lead 
UNC 
maelynn_reyes@med.unc.edu 
Bradley Gaynes, MD, MPH 
Co-I, Trial Expert  
UNC 
bradley_gaynes@med.unc.edu 
University of Chicago/NorthShore University HealthSystem 
Laura La Porte, LCSW 
Co-I, Clinical Lead 
NorthShore, 
UChicago 
LLaPorte@northshore.org 
Jo Kim, PhD 
 
Co-I, Clinical Lead 
NorthShore, 
UChicago 
jkim@northshore.org 
Other 
John Naslund, PhD 
Co-I, Digital Expert 
Harvard  
John_Naslund@hms.harvard.edu 
Vikram Patel, PhD, FRCPC 
Co-I, Trial and NSP 
Expert 
Harvard  
Vikram_Patel@hms.harvard.edu 
Steven D. Hollon, PhD 
Consultant; Trials & 
Psychological 
Treatment Expert 
Vanderbilt 
University 
steven.d.hollon@vanderbilt.edu 
 
Sona Dimidjian, PhD  
 
Consultant; BA expert U Colorado 
Boulder 
sona.dimidjian@colorado.edu 
 
 
 

8 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Table 3. Study Management and Committees.  
Committee  
Role 
Members 
Frequency  
Trial 
Management 
Committee 
(TMC) 
To monitor all aspects of the conduct and 
progress of the trial, ensure that the protocol is 
adhered to and take appropriate action to 
safeguard participants and the quality of the 
trial. 
● Principal Investigator from 
each hub*  
● Trial Coordinators  
● Project Administrator 
● Data Manager 
Weekly** 
Trial Investigator 
Committee (TIC) 
To monitor all aspects of the conduct and 
progress of the trial, including site-specific safety 
protocols within and across sites 
● All Investigators 
● Research Coordinators from 
each site  
● Data Manager 
Biweekly to 
Monthly 
Trial Steering 
Committee 
(TSC) 
To provide overall supervision of the trial and 
ensure that it is being conducted in accordance 
with the protocol and the relevant regulations. 
The TSC should approve the trial protocol and 
any protocol amendments and provide advice to 
the TMC on all aspects of the trial. Decisions 
about continuation or termination of the trial or 
substantial amendments to the protocol are 
finally the responsibility of the TSC. 
● Members of the TMC 
● All Investigators 
● Trial/Content Advisors and 
Consultants 
Six-monthly 
Data Safety 
Monitoring 
Board (DSMB) 
The DSMB will review the accruing trial serious 
adverse event reports to assess whether there 
are any safety issues that should be brought to 
participants’ attention or any reasons for the 
trial not to continue. It is the only body that 
makes recommendations to unblind data and 
makes further recommendations to the TMC. 
● Sherryl Goodman - clinical 
psychologist, with 
experience in BA  
● Tim Oberlander - 
developmental pediatrician 
● Catherine Monk - 
psychologist experience on 
maternal depression 
● Robert Gibbons - 
biostatistician with 
experience on mental health 
trials 
Six-monthly 
*hub refers to locality (Toronto, Chapel Hill, Chicago)  ** weekly meetings also held within sites 

9 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
 Table 4. Protocol Summary Table.  
 
Title 
Scaling Up Maternal Mental healthcare by Increasing access to Treatment 
(SUMMIT) 
Sample Size 
N = 1230 
Study Population 
Women pregnant up to 36 weeks or 4-30 weeks postpartum, with an EPDS 
score ≥10 and capable of giving informed consent.  
Accrual Period 
39 months; Recruitment starts January 2020 and ends Mar 31 2023 
Study Design 
 
A multi-center randomized non-inferiority trial to test the choice of delivery 
mode and provider, implementing a brief evidence-based PT of BA for 
perinatal depressive and anxiety symptoms.  
Study Duration 
01 June 2019 – 31 May 2024 
Study Intervention  
 
Eligible participants will be randomly assigned to the same BA treatment for 
perinatal depressive and anxiety symptoms in one of four arms: 1) In-person 
specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) 
Telemedicine non-specialist. 
Primary Objectives 
 
1. To examine if a brief BA psychological treatment delivered by a non-
specialist provider is as effective in treating perinatal depressive 
symptoms as specialist-delivered treatment. 
2. To examine if a brief BA psychological treatment delivered through 
telemedicine is as effective in treating perinatal depressive symptoms as 
in-person treatment. 
Secondary Objectives 
 
1. To examine the aforementioned questions among secondary outcomes 
including anxiety symptoms (GAD-7). 
2. To conduct subgroup analyses including the role of the perinatal period 
on long-term maternal mental health outcomes at 12-months post-
randomization and child development outcomes at 6-24 months post-
child birth. 
3. To identify relevant and underlying processes related to delivery and 
scalability of a brief PT for perinatal depressive and anxiety symptoms 
from a multi-stakeholder perspective including barriers and facilitators.    
4. To conduct an economic evaluation to examine the cost-effectiveness of 
NSP-delivered and telemedicine psychotherapy to specialist-delivered and 
in-person psychotherapy.   
 
 
 

10 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
1 
INTRODUCTION 
1.1.  Background 
Depression is the leading cause of disability of mothers worldwide1 with an estimated 10 to 
15% of women in the USA and Canada experiencing depression during pregnancy or in the year 
following childbirth2,3. Many of these symptoms begin in the antenatal period4, and estimates 
of the lifetime costs of perinatal depression amount to over $45.9 billion dollars (USD) in the 
USA each year5. Similarly, although given less attention than depression, 15 to 20% of mothers 
experience anxiety symptoms perinatally6, with up to 10% experiencing both7. The negative 
impact of depression and anxiety on the well-being of the mother and her child8-10 underscores 
the importance of addressing perinatal mental health issues.  
Psychological treatments (PTs), including cognitive, behavioral and interpersonal 
therapies, are effective in preventing and treating perinatal depression and anxiety11,12 and 
preferred by women over pharmacological treatment13,14. Yet, across the US and Canada, as 
few as 20% of women with perinatal depression are treated with evidence-based PTs15. Barriers 
to accessing PTs in the perinatal period include childcare needs, unpredictable schedules and 
stigma13,16. In addition, a dearth of financial resources and trained professionals may contribute 
to this burden16.  These barriers are problematic given the recent US Preventive Task Force 
Recommendations for universal screening of all pregnant and postpartum women for 
depression17 and evidence-based psychological treatments18. Thus, there is an urgent need for 
widely accessible, low-cost, and innovative solutions to improve access to psychological 
treatments for perinatal depression and anxiety.  
1.1.1.  Scalable Innovations   
1.1.1.2.  Non-specialist providers. Task-sharing has been used worldwide to improve 
access to care, where non-specialist providers (NSPs)—individuals with no formal training in 
delivering mental health care including nurses, peers, lay counselors, midwives, teachers, and 
primary care doctors—have been trained to effectively treat perinatal depressive and anxiety 
symptoms worldwide19,20. NSPs are an important human-resource because they are widely 
available, affordable, considered trustworthy, and have regular and frequent contacts with 
mothers19,21,22. Worldwide, NSPs have successfully implemented behavioural activation (BA) to 
reduce maternal depressive symptoms23,24, anxiety symptoms24, and even intimate partner 
violence among women of childbearing years23. BA can be as effective in targeting depression 
as traditional and longer courses of CBT25,26. However, evidence is lacking as to whether 
specialists and NSPs are equally effective in targeting perinatal depressive and anxiety 
symptoms when delivering the same treatment.   
1.1.1.3.  Telemedicine. Telemedicine-based PTs—interventions provided through web-, 
app- and/or telephone-based platforms—offer a promising, alternative approach for mothers in 
terms of flexibility27, efficiency28, and costs29—thus increasing accessibility and scalability of 
PTs. Recent reviews show that effects on depressive and anxiety symptoms are similar when 
comparing digital and in-person services30.  Access to PTs nonetheless remains limited15,31. 

11 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
1.1.2.  Why Behavioural Activation? 
BA proposes that the key to feeling less depressed and anxious is to increase enjoyable or 
fulfilling activities that align with one’s values32,33, targeting the mechanisms of patient 
activation and avoidant coping. We will be using a brief, 6-8 session version of BA that was 
shown to be effective in reducing depressive symptoms and enhancing rates of remission when 
delivered by NSPs, with sustained effects in Goa, India (led by co-I Patel and involved the 
PI)23,34. Among effective treatments for depression, BA is an excellent candidate for this study 
for three reasons: 
1. BA has a strong evidence base for effectiveness in the general health care population35,36. In 
a randomized placebo controlled study in the US, BA was as efficacious as, and more 
enduring than, antidepressant medication (ADM), with fewer patients dropping out of 
treatment25,26; in the UK, BA was as effective as longer courses of CBT26,37.  
2. BA is effective in treating perinatal depression. In randomized trials in the US, BA was 
associated with high satisfaction and treatment engagement22,38 and, as compared to 
treatment as usual, offered significant benefit including the reduction of commonly-
occurring anxiety symptoms24,39.   
3. BA is a parsimonious approach that is easy to understand and implement32. This is critical 
when training NSPs. Trials in Colorado24, Uganda40, India23,34, and the UK37 have 
demonstrated that lay counselors, undergraduate psychology students, peers and midwives 
can all be trained to effectively deliver BA or components to reduce depressive symptoms.   
1.2. Rationale 
Our overarching goal of SUMMIT (Scaling Up Maternal Mental healthcare by Increasing access 
to Treatment) is to examine the scalability and patient-centered provision of brief, evidence-
based PTs for perinatal depression and anxiety. Specifically, the current proposal will answer 
the question of the effectiveness of the integration of telemedicine of PTs within larger health 
systems, and whether frontline non-mental health workers, with appropriate training, can 
effectively deliver BA for perinatal depressive and anxiety symptoms. We will identify relevant 
underlying implementation processes and determine whether, and to what extent, these 
strategies work differentially for certain women over others.  Addressing these aims can 
support a stepped care model in which we optimize the use of available resources. In doing so, 
this research has the potential to increase the accessibility, scalability, and cost-effectiveness of 
evidence-base of PTs for perinatal women worldwide.  
1.3 Potential Risk and Benefits 
1.3.1. Potential Risks  
1.3.1.1. Inconvenience. Participants may feel inconvenienced by the time required to 
complete the study task. The expected time commitment will be explicitly stated in the consent 
form.  
1.3.1.2. Psychological risks associated with assessment. There is the possibility that 
participants could be upset or offended by survey questions. In order to minimize psychological 

12 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
harm, information about potential risks is included in the consent form. Participants also will be 
instructed that they are free to not answer any questions they choose on the surveys.   
1.3.1.3. Psychological risks associated with treatment or training.  
1.3.1.3.1. Participants. As in any study related to mental health concerns, discussion of 
symptoms may cause psychological discomfort and participants may also experience 
exacerbation of depressive or anxiety symptoms. Established safety protocols will be 
implemented to offset these risks (Appendix A – Safety Protocols and Forms).  Furthermore, the 
recent United States Preventive Task Force guidelines have suggested that there is no-to-
minimal harm of evidence-based PTs including cognitive, behavioral and interpersonal 
psychotherapies18. 
1.3.1.3.2. Providers. It also is possible that a potential treatment provider may be upset 
if they are withdrawn from the study for not meeting competency standards. We will provide 
clear orientation as part of the training process, and will make referrals for anyone who is 
overly bothered by being withdrawn from the study. In addition, NSPs may become stressed 
while participating as providers. Treatment Providers will receive information and techniques in 
self-care as part of the BA training curriculum and established safety protocols will be 
implemented to offset these risks (see Treatment Provider/Research Assistant Safety, Appendix 
A – Safety Protocols and Forms, pg 5).  
1.3.1.4. Physical Harm. We do not anticipate any physical risks for participants or 
treatment providers. Participants’ physical care needs will remain in the hands of their primary 
care physicians or OB provider during the study. We will ask participants to provide contact 
information and a release of information for their provider in order to communicate any 
physical health concerns during the study involvement should the need arise. We will also ask 
participants for secondary personal contacts (see Secondary Contact Form, Appendix E – Study 
Documents, pg 83).  
1.3.2 Potential Benefits 
1.3.2.1. Participants. This study may provide participants with insight into their mental 
health states and equip them with strategies to overcome their depressive and anxiety 
symptoms. Over the course of the treatment, participants may experience an increase in 
knowledge of mental health symptoms and increase their coping skills over time. In light of 
COVID-19, this study is considered ‘essential research’ by its study institutions by contributing a 
valuable, evidence-based psychotherapy to study participants. 
1.3.2.2. Providers. NSPs may receive the benefit of personal satisfaction from making a 
positive impact on perinatal women struggling with these issues.  
1.3.3.3. Society. Preventing and decreasing the severity of perinatal mental health 
issues offers significant benefits to society, given that depression is a leading cause of disability 
worldwide with serious consequences for offspring. These benefits would be particularly 
marked if the BA treatment provided by NSPs and telemedicine are as effective as those 
delivered by specialists and in-person.  

13 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
1.4. Objectives.  
1.4.1. Primary Objectives 
1. To examine if a brief, BA psychological treatment delivered by a non-specialist provider is as 
effective in treating perinatal depressive symptoms as specialist-delivered treatment, as 
measured by the Edinburgh Postnatal Depression Scale (EPDS)41.  
2. To examine if a brief BA psychological treatment delivered through telemedicine is as 
effective in treating perinatal depressive symptoms as in-person treatment, as measured by 
the EPDS41.  
 
The assessment period will be extended for those women who encounter a hiatus in treatment 
due to significant perinatal-related life events (e.g., giving birth, obstetrical complications, 
COVID-19). 
1.4.2. Secondary Objectives 
1. To examine the aforementioned questions among anxiety symptoms, as measured by the 
GAD-742,43.  
2. To assess moderating effects as to whether clinical severity (mild, moderate and severe) 
and the timing of the treatment (antenatal vs. postnatal) differentially influences depressive 
symptoms and whether timing of treatment influences child mental development at 6-24 
month post-child birth.    
3. To conduct a process evaluation; i.e., identify the underlying processes related to delivery 
and scalability of a brief PT for perinatal depressive and anxiety symptoms from a multi-
stakeholder perspective including relevant barriers and facilitators. 
4. To conduct an economic evaluation to examine the cost-effectiveness of NSP-delivered and 
telemedicine psychotherapy compared to specialist and in-person psychotherapy.  
1.5.  Hypotheses 
1. We hypothesize that among mothers with depressive symptoms, i) telemedicine-PT will be 
as effective as in-person treatment; and ii) NSP-delivered PT will be as effective as 
specialist-delivered PT at 3-months, post-randomization. 
2. Our secondary hypothesis is identical to those above with anxiety symptoms at 3-months, 
post-randomization.  
3. We hypothesize that non-specialists and telemedicine will be less costly to deliver, equally 
effective and associated with similar use and cost of other health services, and thus likely 
cost-effective compared with specialist providers and in-person sessions 
1.6.  Study Design 
This is a multi-center randomized non-inferiority trial to test the choice of delivery mode and 
provider, implementing a brief evidence-based PT of BA for perinatal depressive and anxiety 
symptoms, and to determine the underlying processes related to delivery and scalability of the 
PT from a multi-stakeholder prospective. 

14 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
2 
METHODS – Participants, Interventions and Outcomes 
 
2.1.  Participants and Setting.   
N=1230 pregnant and postpartum women, aged ≥18, will be recruited from three study centers 
though their networks of clinics. Participants will be drawn from diverse and representative 
populations in Toronto, Chapel Hill, and Chicago.  The flow chart (Figure 1) shows the process of 
recruitment and follow-up of participants in each hub. In Toronto, we will recruit from Sinai 
Health (SH), Women’s College Hospital (WCH) and St. Michael’s Hospital (SMH)—three major 
academic hospitals that are all affiliated with the University of Toronto, and our external 
referral networks. In North Carolina, we will recruit from three clinical sites affiliated with the 
University of North Carolina (UNC) Women’s and Neuroscience Hospitals.  In Chicago, we will 
recruit from fourteen affiliated obstetric and family medicine clinics.  Our trained research 
assistants will approach all attending women or contact via phone for a screening.  At one site 
(WCH), permission will first be required by a member of the participant’s circle of care, will 
introduce the study and ask if she is interested in learning more.  If the participant agrees, the 
trained research assistant will approach the participant in person or via phone for screen. 
Recruitment personnel will use established safety protocols (Appendix A - Safety Protocols and 
Forms). Inclusion and exclusion criteria are detailed in Table 5. Screening will take place in-
person or over the phone, as determined by the referral pathway.  
Table 5. Inclusion and Exclusion Criteria  
INCLUSION 
EXCLUSION 
● 
EPDS≥10 
● 
≥18 years 
● 
Pregnant up to 36 weeks or 4 to 30 weeks postpartum 
● 
Speaks English or (US sites) Spanish 
● 
Active suicidal intent (ideation and plan), active symptoms 
of psychosis or mania  
● 
Psychotropic medication dose or medication change within 
two weeks of enrollment or beginning treatment  
● 
Ongoing psychotherapy (no more than once every 8 weeks 
or during the duration of the intervention) 
● 
Active substance abuse or dependence 
● 
Severe fetal anomalies, stillbirth or infant death at time of 
enrollment for index pregnancy 
● 
Non-English, non-Spanish speakers  
Following informed consent, potential participants will be screened for eligibility using a list of 
previously-used and validated measures. Our screening measures are briefly described below 
and can be found in SUMMIT Screening Measures, Appendix C – Study Measures, pg 4. 
● Active suicidal intent will be assessed using the Columbia Suicide Severity Rating Scale44. 
This is the most commonly used scale to assess suicide risk and has been used extensively 
with adult populations and by our own teams among adult perinatal populations45.  
● Active symptoms of psychosis will be assessed using two screening questions: "Do you hear 
things that others can't or don't hear?" and "Have you ever felt that someone was playing 
with your mind?" The measure was validated against clinician ratings of psychosis, and 
performed with strong psychometric properties including a sensitivity of 53% and specificity 
of 98% for clinically significant hallucinations or delusions, and sensitivity of 32% and 
specificity of 99% for identifying people in an early phase of psychosis (clinical high risk or 

15 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
first episode psychosis).  To reduce false positives, these two stem questions have been 
further adapted for the purposes of this study and perinatal population to be supplemented 
with probes from the frequently used Mini International Neuropsychiatric Interview 
(MINI)46.  
● Mania will be assessed using a one-item question that asks “In the last two weeks, have you 
had periods of feeling so happy or energetic that you did not need to sleep or behaved in 
ways that were unusual for you and did this worry your friends and family?”. This question 
has been used extensively by UNC Perinatal Mood Disorders Program47.  
● Alcohol use will be assessed using the Alcohol Use and Disorders Identification Test (AUDIT) 
has been used extensively worldwide to screen for alcohol use and dependence48. Its 
psychometric properties are well-validated49 and patient-centered in its brevity.  
● Three questions, borrowed from the psychometrically-robust DAST Drug Use 
Questionnaire50, will assess participants’ reported drug use to determine whether 
participants engage in drug use and the extent to which it influences their lives. We selected 
three key questions as individuals have found that even single-item questionnaires are valid 
to assess drug use in primary care 51. These three questions are:   
a. Do you currently use drugs other than those required for medical reasons? [Probe: 
[if NO] What about marijuana?] 
b. Does it negatively impact your life? 
c. Does your spouse (or parents) ever complain about your involvement with drugs? 
● Finally, severe fetal anomaly, stillbirth or infant death will be determined by participant 
self-report and/or verified with a chart review. Language aptitude in English or Spanish 
will be determined when the potential participant is approached.  
 

16 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Figure 1: Study Flow Chart 
 
Figure 1 
2.2.  Treatment and Intervention Arms 
2.2.1.  Treatment. The intervention will consist of six to eight weekly sessions of BA delivered to 
each participant individually.  The current manual (Appendices B1 and B2 – Treatment Manual 
and The PREMIUM Counselling for Relationships Manual, respectively)) have been adapted from 
two well-established and tested manuals— the Alma Program for perinatal populations in 
Colorado and the Healthy Activity Program (HAP) from Goa, India, respectively. BA posits that 
the key to feeling less depressed is to increase enjoyable or fulfilling activities that align with 
one’s values32,33 and targeting the mechanisms of patient activation. Unlike other cognitive 
behavioral interventions for depression, BA explicitly targets avoidant coping, treating it much 
like any other anxiety disorder. This should facilitate our secondary focus on anxiety. Key 
strategies include: psychoeducation, behavioral assessment, activity monitoring and 
structuring, activation of social networks, interpersonal effectiveness, and problem solving.  
 
2.2.2. Treatment indicators.  Compliance is defined as attending a minimum of six sessions 
(reduced if patient has two consistent sessions of EPDS session-wise scores<10) over a period of 
four months unless a pregnancy- or COVID-related hiatus is experienced. Reasons for dropout 
will be recorded in the individual patient’s treatment log (see SUMMIT Treatment Log Record 
Form, Appendix C – Study Measures, pg 40) using a data capture and storage system called the 
Research Electronic Data Capture (REDCapTM). Response and remission will be defined as PHQ-
9 of less than 10 and less than 5, respectively, at 3-months post-randomization. This period will 
be extended in the event that there is a hiatus to treatment due to significant perinatal-related 
life events (e.g., giving birth, obstetrical complications, COVID-19). Another indicator will 
include the estimation of comorbidity on both the EPDS and GAD-7.  
 
2.2.3. Intervention Arms.  During regular operations participants will be randomized to one of 
four arms (Figure 2): 
 
Figure 2. Intervention Arms 
 
2.2.3.1 Telemedicine vs. In-Person. Telemedicine will be implemented via the Ontario 
Telemedicine Network and ZoomTM in Toronto, via the UNC TelePsychiatry Program in Chapel 
Hill, and via ZoomTM in Chicago. All offer secure personal videoconferencing service, are free to 

17 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
registered healthcare providers (including nurses), and PHIPA/HIPAA compliant. They also 
permit video-visits and scheduling and are accessible on PC, Mac, Android and iOS systems. For 
participants who do not have access to a phone, tablet, or computer, or whose device 
malfunctions, study tablets will be available and enabled for use on a temporary basis. 
Instructions for use will be provided. During telemedicine sessions, established safety protocols 
will be implemented (see Appendix A – Safety Protocols and Forms). Participants assigned to 
Telemedicine can do their BA sessions in whatever private location they prefer (e.g., home or 
elsewhere). In-person sessions will be held at participating clinical care sites within UToronto, 
UNC and NorthShore Chicago.  
2.2.3.2 Non-Specialists vs. Specialists. SUMMIT treatment providers will include both 
non-specialist providers (NSPs) and specialists. NSPs will be healthcare workers with general 
health care professional skills (as assessed during recruitment) but without formal training in 
mental health care or experience delivering PTs. Specialists will include individuals with formal 
training in mental health care delivery (e.g., psychiatrists, psychologists and social workers) with 
experience in treating perinatal mental illness and a minimum of 5 years of experience 
delivering psychological treatments.  To ensure consistency across hubs, a minimum of two 
clinical leads (i.e., expert Co-I’s designated to oversee the training and clinical implementation 
of the BA treatment), one from the local hub and one from another hub, will conduct training.  
The original study design included a 4-arm, 1:1:1:1 randomization strategy (Phase 1, see 
Figure 3 below) which was modified to a 2-arm, 1:1 (telemedicine only; Phase 2) strategy at the 
start of the COVID-19 pandemic. Following vaccine rollout and the subsequent decrease in 
COVID-19 cases, we transitioned to a weighted 4-arm, 3:1 (in-person:telemedicine; Phase 3) 
strategy in an effort to equalize the number of randomized in-person to telemedicine cases. 
However, in light of the frequently changing COVID-19 situation, we will transition to an 
adaptive study design (Phase 4) in which we move between a balanced 4-arm randomization 
strategy (1:1:1:1; similar to Phase 1) and a 2-arm (telemedicine only; similar to Phase 2) 
randomization strategy (1:1) (Figure 3) based on COVID-related institutional restrictions that 
impact in-person care and recommendations at each site. This protocol modification will allow 
us to continually adapt to the rapidly-changing COVID-19 situation and reflects the pragmatic 
and patient-centered nature of this study. Participants will be informed about these ratios in 
the consent forms (see Informed Consent Form – 2 Arm, Appendix E – Study Documents, pg 4 
and Informed Consent Form – 4 Arm, Appendix E – Study Documents, pg 16). The study design 
and relevant statistics have been reviewed by the study team, biostatistician and independent 
board of trial advisors.   

18 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
 
Figure 3. Updated Randomization Strategy 
 
2.3 Non-Specialists: Recruitment, Training, Supervision and Selection  
2.3.1 Recruitment. Recruitment of NSPs will be based on the aforementioned 
inclusion/exclusion criteria as well an expressed desire to help women with depressive and 
anxiety symptoms. During recruitment, a selection interview will take place, whereby NSPs are 
assessed based on their common skills—the style with which they interact with a mock 
patient—using the Therapy Quality Scale52.  We have used this method previously and found 
that it correlates with trainee competency. Trainee providers will be recruited by placing 
advertisements in newspapers and through word of mouth, and selected based on their 
performance in a structured interview and role-play during an intake interview. The same 
procedures will be implemented in each hub.   
 
2.3.2. Training & Competency Tests. In Fall 2019, those trainees selected will be invited 
to participate in a 5-day participatory training workshop covering the manualized BA treatment 
for perinatal mental health populations (Appendix B1 – Treatment Manual) and an adapted 
version of The PREMIUM Counselling for Relationships Manual23 (Appendix B2 – The PREMIUM 
Counselling for Relationships Manual). Trainees who meet competency standards (based on a 
multiple-choice questionnaire used for another BA trial; see Competency Measure Survey, 
Appendix C – Study Measures, pg 49) and in an interaction with a standardized patient (actor) 
rated by experts using an adapted version of the Q-HAP52 (see Quality of Healthy Activity 
Program (Q-HAP), Appendix C – Study Measures, pg 45) will be selected for the 8-week 
internship phase of the trial. During the internship phase, trainees will see up to 2 participants 
(one via telemedicine and one in-person) to implement the BA treatment. In addition, all 
trainees will receive training in the safety protocols (see Appendix A). 
2.3.3. Supervision. The trainees will receive weekly group supervision from the hub 
intervention lead (see Table 1 above). All intervention leads are co-I’s on the current study, with 
a minimum of 10 years’ experience training and supervising lay and specialist therapists in 
psychological treatments and who have allocated time to focus on providing training and 

19 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
supervision to NSPs. Therapy quality will be assessed using a reliable and validated tool (an 
adapted version of the Q-HAP52; see Quality of Healthy Activity Program (Q-HAP), Appendix C – 
Study Measures, pg 45). As the trainee counsellors gain experience in delivering the 
intervention, the supervision format will evolve from expert led (that is, the clinical lead and 
specialist who is skilled in the delivery of the PT) to peer-led group supervision. All treatment 
providers will record all BA sessions for training and supervision purposes and for fidelity 
measures. 
 
2.3.4. Selection. Only trainees who achieve competence, as assessed by standardised 
role-plays and therapy quality assessments, will be selected to deliver BA during the trial.    
 
2.4 Specialists. Specialists will include a wide range of specialties (e.g., psychiatrists, clinical and 
counseling psychologists, social workers) with a minimum of 5 years of formal experience in 
delivering psychological treatments. They will be recruited through word-of-mouth and based 
on their location, interest and availability, and good standing with their respective colleges. In 
Fall 2019, specialists will also receive the BA workshop followed by an internship phase where 
they will see up to 2 participants each with expert-led supervision followed by guided peer-
supervision. The primary focus of the workshop for the specialists will be on the contents of the 
BA manual. 
To assess provider proficiency with telemedicine, we will collect information from the trainees 
about their perceived telemedicine proficiency at the end of training and then after their last 
session with each participant during the internship phase (see SUMMIT Perceived Telemedicine 
Platform Proficiency Self-Assessment Questionnaire (for providers), Appendix C – Study 
Measures, pg 105).  Participants assigned to the given provider will also be asked to rate their 
provider’s telemedicine proficiency after their last session (see SUMMIT Perceived Telemedicine 
Platform Proficiency Self-Assessment Questionnaire (for participants), Appendix C – Study 
Measures, pg 105). The questionnaire is a brief, 5-item scale rated from 0 (Strongly Disagree) to 
4 (Strongly Agree). 

20 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
2.5.  Outcomes and Timing of Assessments.  
Table 6.  Outcomes 
Study Variable 
Instrument 
Outcome (Range) 
Maternal: Measured at Baseline and 3*-, 6- and 12-months post-randomization  
Maternal Characteristics** 
Trial Baseline Questionnaire53,54 
Self-reported age, education level, marital status,  immigrant status and ethnicity, clinical history 
with depression or anxiety (severity, chronicity, number of prior episodes, and age at first 
episode, occupational status, number of children, pregnancy intention, pregnancy history, 
delivery and birth, sexual orientation. 
Depressive Symptoms 
Edinburgh Postnatal Depression Scale (EPDS)41 
Mean continuous score of a 10-item scale (0-30) 
Anxiety Symptoms 
Generalized Anxiety Disorder Scale (GAD-7)42 
Mean continuous score of a 7-item scale (0-21) 
Response & Remission 
Patient Health Questionnaire-9 (PHQ-9)55 
Response: PHQ<10 
Remission is defined as PHQ<5 
Perceived Support 
Multidimensional Scale of Perceived Social Support56  
Mean continuous score of a 12-item scale (1-84) 
Disability Assessment 
World Health Organization Disability Assessment Schedule 
(WHODAS)57 
Mean continuous score of a 12-item scale (0 – 48) 
Quality of Life Assessment 
EQ5D-5 Level (EQ5D-5L)58  
Mean continuous score of a 5-item scale (1-25) 
Trauma Symptoms 
Abbreviated PTSD Checklist (PCL-6)59 
Mean continuous score of a 6-item scale (1-30) 
Patient-Reported Activation  
Premium Abbreviated Activation Scale34,60  
Mean continuous score of a 5-item scale (0-20) 
Patient Satisfaction*** 
Client Satisfaction Questionnaire-8 (CSQ-8)61 
Mean continuous score of an 8-item scale (1-32) 
Therapeutic Alliance*** 
Working Alliance Inventory-Short Revise (WAI-SR)62 
Mean continuous score of a 12-item scale (1-60) 
Health Service Utilization 
Health Service Utilization Form63  
3, 6 months - Total score of a 16-item scale (0-32); 12 months – Total score of a 19-item scale (0 – 
38) 
Treatment Preference** 
Delivery of treatment and treatment provider preference 
Score of 0 or 1  
COVID-19 Exposure 
1-item question on COVID-19 exposure 
Self-reported  
Health Benefits Access and Use 
2-item question on access and use of health benefits 
Self-reported 
Sexual Orientation◊ 
2-item question on sexual orientation 
Self-reported 
Home Visit Survey□ 
4-item question on home visit perspective 
Self-reported 
Intervention Costs 
A survey of costs associated with the intervention 
Self-reported and health records, related to the economic evaluation portion of the study  
Treatment: Measured at every session during treatment, unless otherwise indicated  
Dosage 
Treatment Log64 
Frequency of Sessions Attended 
Therapy Quality**** 
Quality of Healthy Activity Program (Q-HAP)52 
Mean continuous score of treatment-specific BA skills (0-4) and general counseling skills (0-4) 
Session Depressive / Anxiety 
Session-by-session EPDS41 and GAD-742 scores 
Mean continuous score of a 10-item scale (0-30) on EPDS and of a 7-item scale (0-21) on GAD-7 
Homework Adherence 
Treatment Log64 
Mean continuous score of a 1-item question (0-2) 
Adverse or Serious AEs   
Anytime an Adverse Event (AE) or Serious AE occurs 
Any event that represents a series threat to the safety of the mother or her child (see Appendix D)  
Health Service Utilization 
Health Service Utilization Form63  
Total score of a 16-item scale (0-32) 
List of Medications 
List of Medications 
Self-reported list of medications 
COVID-19 Exposure 
1-item question on COVID-19 exposure 
Self-reported  
Child: Measured at 6 to 24-months post-child birth unless otherwise indicated 
Birth weight & Length 
Retrieved from hospital chart or self-report† 
Assessed at birth  

21 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Breastfeeding 
Whether breastfeeding and if stopped age stopped.54 
Total Number of Months (0-12) 
Psychosocial Stimulation  
Home Observation Measurement Evaluation65 
Total score of a 45-item checklist  
Mental Development 
Bayley Mental Development Scales IV66 
Mean continuous score of cognitive, receptive and expressive language development  
* Assessment period will be extended to account for post-treatment outcomes when there are perinatal-related interruptions to treatment (e.g., giving birth, obstetrical 
complications, COVID-19); **Only at baseline; ***Measured at 3-months post-randomization only; ****Randomly selected for supervision, rated by self, peers, expert 
supervisor; †Self-report will be used when hospital charts are outside of the recruiting site; ◊Measured at baseline for participants consented after addition of measure to 
baseline questionnaire, measured at 12-months post-randomization for those who completed baseline before addition of measure; □Measured once at 3-, 6- or 12-months post-
randomization.

22 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
All measures proposed in the current study have been previously used and validated in one or more of 
the investigators’ trials targeting perinatal mental health23,24,34,40,53,54,60,67,68 and selected because of 
their role in the presumed causal pathway. Our emphasis on mothers’ self-reported data adheres to 
PCORI’s methodology standards that emphasize that the patient population is the best source of 
information. 
    
2.6. Sample Size  
The primary outcome measure will be participant’s EPDS mean score at 3 months after 
randomization; the assessment period will be extended in the event that there is a hiatus to 
treatment due to significant perinatal-related life events (e.g., giving birth, obstetrical 
complications, COVID-19) or to one week after the last session if participants complete 
treatment after the 3 month-post randomization period.  The study is designed to be a non-
inferiority trial with four arms: telemedicine specialist, telemedicine non-specialist, in-person 
specialist, in-person non-specialist. The two primary hypotheses are that telemedicine will be 
non-inferior to in-person, and that non-specialist delivery agents will be non-inferior to 
specialist delivery agents. The sample size calculation is based on an EPDS mean estimate of 
7.93 (SD=4.6853). Using a non-inferiority margin of 10% (i.e., EPDS score of 0.79) in relation to 
the mean), and an alpha=0.05 for our first comparison (NSP vs. SP) we require 431 participants 
in each of the two groups to provide greater than 80% power. To account for 10% drop out, the 
sample size is inflated to N=958 (479 per group, NSP vs. SP). Using a non-inferiority margin of 
13% (i.e., EPDS score of 1.03 in relation to the mean), and an alpha=0.05 for our second 
comparison (TM vs. IP), we require an additional 268 IP participants. When combined with the 
958 TM participants, this yields a total study sample size of N=1,226 which accounts for 10% 
loss to follow-up. Previous randomized non-inferiority trials37 have demonstrated that a 14% 
non-inferiority margin can be considered clinically meaningful.   
We are planning a final sample size of N=1,230, four more participants than the power 
calculation requires. The reason for this n=4 over recruitment, is to provide flexibility due to the 
fact that we do not receive each site’s recruitment numbers until the end of each day. These 
statistics have been reviewed and approved by our study statistician.   
 
2.7.  Screening, Recruitment, and Consent  
2.7.1. Quantitative Data. Across the three hubs, we anticipate assessing 18,280 participants for 
potential eligibility, obtaining informed consent to screen 9,140, and recruit and retain a 
sample size of N=1,230 women (see Figure 1).  We anticipate that 50% of participants will be 
recruited in Toronto, and 25% each in Chapel Hill and Chicago, respectively. Participants will be 
recruited from all study sites though their networks of in-patient obstetrical units, family 
practice, obstetrical and mental health clinics, and community partners (see Recruitment Poster 
– 4 Arm Without Tabs, Appendix E – Study Documents, pg 123). Referrals will also be elicited 
from clinicians from site hospitals and satellite clinics who will send patient contact information 
to the research coordinator.  Relevant stakeholder groups, such as Life with a Baby, will also be 
provided with information about the trial to share with their members.  Interested individuals 
can contact the trial for more information.   
To help alleviate the mental health burden that COVID-19 imposes on our health care 
systems, physicians not affiliated with a study site will be able to refer their patients to the 

23 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
SUMMIT Trial for screening and enrollment, if eligible and willing. This includes referrals from 
physicians not affiliated with the trial (external referrals) and referrals between recruitment 
sites (internal referrals). Internal referrals will occur among patients who express interest in 
participating in the trial at a study site where recruitment is on temporary hold due to 
treatment provider capacity. 
1. External referrals: Study Investigators will notify their physician colleagues not 
affiliated with a study site that the SUMMIT Trial is open to their patients (see  Email 
for External Physicians, Appendix E – Study Documents, pg 126 and 129) and provide 
a description of the study (Information for External Physicians, Appendix E – Study 
Documents, pg 125 and 128).  Physicians will briefly describe the study to their 
patients, and ask them if they are interested in learning more.  If the patient is 
interested, the physician will then request their patients’ permission to send their 
name and contact information to the study team.  Potential participants may also 
learn of the trial through relevant stakeholder groups in which they are members 
(for example, Life with a Baby).  Interested individuals will be able to contact the trial 
for more information. 
2. Internal referrals: Patients who express interest in participating in the trial at a study 
site may not be able to immediately access treatment if randomization is 
temporarily paused due to reaching treatment provider capacity.  In this event, 
patients will be given the option of a referral to the trial at a different site that is still 
able to accept new participants.  If they agree, the study team at the referring site 
will request the patient’s permission to send their contact information to the study 
team at the second site.  Contact information will be faxed or encrypted and sent via 
secure hospital email to a secure hospital email at the second site. No identifying 
information will be included in the title or body of the email.  Participation in the 
trial at the second site will not affect the patient’s care at the referring site.  Upon 
receipt of the contact information, the study team at the second site will contact the 
patient and follow the consent procedures described in this protocol. 
Women will be contacted either by a trained research assistant, a treating physician or 
another member of the circle of care to ask whether they can be contacted by one of the 
trained research assistants. They will then receive a brief overview of the study by a research 
assistant, while an in-patient, visiting an out-patient clinic, or over the phone. Women who 
agree will then be fully informed of the study procedures by the research assistant, and given 
an informed consent form (see Informed Consent Form, Appendix E – Study Documents, pg 4 
and 16) to review.  Women will be given as much time as they need to decide whether they 
wish to participate, and the research assistant will answer all questions they may have.  Once 
they sign the consent form, women will be screened using the Edinburgh Postnatal Scale for 
Depression (EPDS≥1041) and General Anxiety Disorder (GAD)-742 for eligibility.  If an EPDS 
administered in the last 7 days is in the patient’s clinical chart, we will use and enter that score 
for screening instead of asking the patient to complete the scale again.  In the interest of 
patient-centered care, women who give their permission may also complete informed consent 

24 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
over the phone, witnessed by a third-party.  These women will be mailed a consent form and be 
fully informed of the study procedures by the research assistant over the phone.  If they decide 
that they want to participate, they will give verbal consent verified by a third-party (a second 
study team member), and will then be emailed links to screening measures.  These women will 
be provided with a self-addressed, stamped envelope to mail their signed consent forms back 
to the site, and will then be sent a consent form with their own signature and the name and 
signature of the RA who obtained their informed consent for their files.   
To reflect the pragmatic and patient-centered nature of the trial and in an effort to 
uphold recommended social distancing guidelines for both participants and research staff, we 
will not ask participants to mail back signed consent forms during COVID-19 and will instead 
rely on verbal consent given over the phone and confirmed by a third party.  To ensure a paper 
trail, participants will also indicate their consent in REDCapTM. During verbal consent, 
participants will be sent a link to a consent form in REDCapTM.  The consent form will be the 
same as the form they receive for verbal consent, but will include checkboxes for each 
permission and a checkbox to indicate that they agree to participate in the trial.  The research 
assistant obtaining informed consent and the third party will add their names and signatures to 
the form to indicate that they explained the study and confirmed consent. Participants will not 
enter their names in REDCapTM during this process.  Consent forms will only be identified by 
participant ID and will be linked to participant profiles in REDCapTM, respectively.  
At the American sites, research assistants will either be bilingual or use a translation 
service so that they can explain the study to potential participants who only speak Spanish and 
a consent form will be provided in that language. All study questionnaires and the BA 
intervention will be conducted in Spanish for Spanish-speaking participants. Recruitment rates 
will be closely monitored.  Self-referrals will also be accepted if recruitment rates are low. 
Brochures outlining the study’s aims, potential impact and inclusion/exclusion criteria will be 
provided to all recruitment sites (see Brochure, Appendix E – Study Documents, pg 115 and 
117).Trained research assistants will follow-up with each appropriate referral and obtain 
informed consent (Figure 3).  Recruitment will begin in January 2020 and continue until March 
2023 (39 months in total) at all sites.  
 
 

25 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
 
 
Figure 4: Recruitment Process 
 
2.7.2. Qualitative Interviews. A team of trained interviewers will collect qualitative data 
through semi-structured, in-depth interviews and focus group discussions. These individuals will 
be independent from both the recruitment and data teams. Topic guides were developed and 
reviewed with a range of key stakeholders to ensure questions are relevant and acceptable. 
2.7.2.1. Qualitative Phase 1 (Sep 2019 to Apr 2020). All NSPs, specialist providers, and 
supervisors will take part in qualitative semi-structured interviews to explore their work 
experience related to training and supervision.  All potential treatment providers will be 
informed that they will be required to complete interviews when they are recruited. All 
successful applicants who accept the positions as providers or supervisors will understand that 
in accepting the position, they will participate in semi-structured interviews that will be used in 
the research study as a part of their job. 
2.7.2.2. Qualitative Phase 2 (May 2020 to Mar 2024). A subset of study participants, 
significant others, treatment providers and supervisors, and a wide range of stakeholders 
(patient advocates, health professionals, and policy makers) will be invited to participate in 
qualitative, semi-structured interviews to examine key aspects of the intervention, including 
content, delivery and modality, enactment of key messages, scalability, and, where applicable, 
supervision procedures.  In the first six months of this process, we will also ask several semi-
structured questions to examine whether aspects of the treatment content or delivery were 
modified in light of COVID-19.  
Participants. – We will conduct the qualitative interviews with representative subsets of 
perinatal participants (n=300) across the four arms, selected to represent different variables 
such as symptom severity, perinatal period (antenatal and postnatal), sociodemographic 

26 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
variables, and treatment completion status (completers and non-completers). Potential 
participants will be identified by the Data Manager and approached by a research assistant if 
they would consider taking part in the interviews. A research assistant will approach those 
willing to explain the interview process and secure informed consent (see Informed Consent 
Form – Participant Qualitative, Appendix E – Study Documents, pg 37).  The research assistant 
will answer any questions and the women will be given as much time as they need to make an 
informed decision. Please note that this research assistant is independent and has not 
conducted any baseline or follow-up assessments with potential participants. 
Significant Others. – Up to 60 significant others will be interviewed      as a part of 
Qualitative Phase 2. Participants will indicate in their informed consent form if their partners 
can be contacted to participate in interviews about their experiences related to the treatment 
intervention. If they indicate yes, we will ask the participants to speak with their significant 
others and let their significant other know that they may be contacted by a research assistant.  
Spouses or partners are preferred but we will accept any significant other that the participant 
identifies. If the participant agrees, a research assistant will contact their partner and explain 
the interview process and secure informed consent (see Informed Consent Form – Partners 
Qualitative, Appendix E – Study Documents, pg 46) to review. The research assistant will answer 
any questions the partners may have via whatever means of communication they prefer (e.g., 
phone or email), and the partners will be given as much time as they need to make an informed 
decision. 
Treatment Providers and Clinical Leads. – All NSPs, specialist providers and clinical leads 
will be expected to participate in the Qualitative Phase 2 interviews as a part of their job 
description.  Treatment providers and clinical leads were previously asked to provide informed 
consent to participate in up to three interviews and then will be given a consent addendum 
form to agree to participate in an additional five interviews for a total of eight interviews.   
Other Stakeholders. – Other stakeholders include relevant health professionals (e.g., 
nurses, midwives and physicians from mental health, obstetrics and family medicine), patients 
and patient advocates, telemedicine and insurance experts, study staff, and policy makers 
identified by the PIs at each site and invited to engage in the trial as committee members and 
consultants. Stakeholders are informed that qualitative interviews about their views and 
experiences are a voluntary part of the study and that they will be sent invitations to 
participate.  The research assistant will send a link to the informed consent in REDCapTM by 
email (see Informed Consent Form – Stakeholders Qualitative, Appendix E – Study Documents, 
pg 55, Informed Consent Form – Staff Qualitative, Appendix E – Study Documents, pg 62 
,SUMMIT Stakeholder Email Interview Invite – Appendix E – Study Documents, pg 61 and 
SUMMIT Staff Email Interview Invite – Appendix E – Study Documents, pg 68).  The stakeholders 
will be able to ask the research assistant any questions they may have by phone or email, and 
the stakeholder will be given as much time as they need to make an informed decision.  The RA 
will follow up with stakeholders who do not respond to the email to check if they have any 
questions and if they are interested in participating. 
 
 
 
 

27 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
2.8.  Randomization  
All participants will be stratified by perinatal period (antenatal vs. postnatal) and then 
randomized within site to one of the four arms, unless restricted to two arms due to COVID-
related institutional restrictions of in-person care (see section 2.2.3.2) and using a web-based 
randomization service as part of REDCap™. Randomization will occur only after informed 
consent has been obtained and all baseline measures have been completed and all 
inclusion/exclusion criteria verified with the participant. We will enroll equal numbers in each 
of the four intervention arms. This strategy allows sufficient power to determine whether NSPs 
are no less efficacious than specialists and telemedicine is no less efficacious than in-person 
treatment, respectively, in settings that collectively assure ethnic and racial diversity, as well as 
potential heterogeneity in age, variability in symptom severity as well as access to resources. 
 
2.9. 
Blinding and Masking  
If eligible, baseline assessments will be carried out on site at time of recruitment or at home, as 
per the participant’s preference. The baseline assessment will be accessed by a secure link sent 
via REDCapTM, which participants will be asked to complete before their first treatment session. 
Once baseline is completed, the participants will be randomized.  The outcome assessments at 
3, 6, 12-months post-randomization will also be completed by secure links sent via REDCap™. 
Participants and providers will not be blind to treatment allocation; however, both will be told 
that we are evaluating the same intervention and there is clinical equipoise about whether one 
is better than the other. Outcome measures for participants will be administered through 
REDCap™. Trained research assistants independent of the treatment delivery and blind to 
allocation status will conduct the participant interviews and child assessments. 
 
2.10. Economic Evaluation 
We will evaluate the cost-effectiveness of non-specialist providers and telemedicine, compared 
to specialist providers and in-person sessions. We will undertake a cost-utility analysis 
conducted at the 12-month post-randomization follow-up point. The primary outcome will be 
quality-adjusted life years (QALYs) calculated using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) 
measure of health-related quality of life, collected at 3, 6 and 12-months. 
2.10.1. Economic-related data. The primary outcome related to the economic evaluation is 
quality adjusted life years (QALYs) calculated using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) measure 
of health-related quality of life58. An advantage of the EQ-5D-5L is that an overall utility score of health-
related quality of life can be obtained, which facilitates comparisons with other interventions and health 
states in other illnesses.  
2.10.2. Service use. The use of all health services, other than the intervention (BA), are being 
recorded using an adapted version of the health services utilization questionnaire (HSUQ)63. Data on the 
use of BA (number and duration of therapy contacts and with whom) will be collected from existing 
clinical records. This measure (see Health Service Utilization Questionnaire, Appendix C – Study 
Measures, pg. 35) was adapted with reference to other measures used in perinatal depression 
populations69 and for use in Canadian and US contexts with input from service users and clinicians. It will 
be completed at baseline (covering the last 3 months) and each follow-up interview (covering the period 
since the last interview). The HSUQ records use of health services, specifically: hospital inpatient stays, 

28 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
outpatient appointments, emergency department visits and ambulance contacts, and community health 
contacts.  
2.10.3. Costs. BA will be directly costed for each comparison taking a standard micro-costing 
approach70. Unit costs for BA will include all employer costs and appropriate overheads (capital, 
managerial, administrative etc.; see List of Costs, Appendix C – Study Measures, pg. 108). The cost of 
supervision will be included and the time each therapist spends on various direct and indirect 
participant-related activities (non-participant contact time including, for example, training, 
administration, meetings with other professionals etc.) will be estimated using a questionnaire. Data on 
the use of all other health services will be costed for each individual participant over the course of the 
trial. Unit costs in both Canada and the USA will be obtained from Canadian guidelines on person-level 
costing71 and local Medicaid, Medicare, and private insurer fee schedules commonly available in the 
US72, respectively.  
3 
METHODS – Data Collection, Management & Analysis 
 
3.1.  Data Collection  
Two types of data will be collected.  
3.1.1.  Quantitative Data. All variables will be recorded into the web-based data management 
software REDCapTM.  All variables, with the exception of those recorded in the treatment log 
collected by the delivering provider (see SUMMIT Treatment Log Record Form, Appendix C – 
Study Measures, pg 40) and childbirth outcomes, will be automated for collection via REDCapTM. 
Children will be assessed in-home at 6-24 months post-birth (Figure 1; Table 6) with data 
recorded in REDCapTM.  
 
3.1.2.  Qualitative Data. An independent team of trained interviewers will collect qualitative 
data through audio-recorded, semi-structured, in-depth interviews and focus group discussions.  
Interviews will examine key aspects of the intervention including intervention content, delivery, 
and enactment. Interview guides were developed and reviewed with specific advisory 
committees including mothers and clinicians will be used. A maximum variance, purposive, and 
snowball sampling approach will be used, when applicable, to adequately capture participants 
across severity levels, perinatal periods, sites, key sociodemographic factors and stakeholder 
groups.   
3.1.2.1. Qualitative Phase 1. We will explore experiences related to training by 
examining relevant barriers and facilitators reported by trained NSPs, specialists and 
supervisors. All providers and supervisors will be interviewed by stakeholder group and within 
each hub. Individuals will be interviewed at the end of training that will take place in Fall 2019 
and before the trial, and interviews with newly on-boarded providers will be conducted on an 
ongoing basis.  
3.1.2.2. Qualitative Phase 2. We will assess the relevant barriers and facilitators of the 
intervention delivery and implementation with a subset of participants from the existing trial 
and with multiple stakeholders approached to participate in semi-structured interviews.  We 
will conduct interviews with various subsets of n=300 perinatal participants who have been 
enrolled in the study, including representation from each of the four arms, treatment 
completers vs non-completers, and antenatal vs postnatal enrollment. An unblinded data 

29 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
manager will identify potential participants. In addition, we will interview up to n=6     0 
significant others (including spouses or partners of participating perinatal participants), all 
specialist and non-specialist providers, and n=160 health professionals and relevant 
stakeholders such as patient advocates. A maximum variance, purposive, or snowball sample 
will be used, when applicable, to adequately capture participants across severity levels, 
perinatal periods, sites key sociodemographic factors and stakeholder groups. Each type of 
group will consent to being interviewed three times, except for treatment providers who may 
be interviewed up to eight times (see Treatment Provider Qualitative Addenda, Appendix E – pg. 
37 – 40), and interviews will be conducted during all phases of the trial (beginning, middle, and 
end) to ensure that we are capturing relevant aspects of the interventions while it is being 
implemented. In addition, we will interview all treatment providers and clinical leads again to 
assess their perspectives over a later part of the trial and in the event that there are new 
providers trained. Finally, we will examine the data to see whether there were specific barriers, 
facilitators and modifications made to the content and delivery of the BA treatment in light of 
COVID-19.  
3.2.  Drop Out and Follow-Up Strategies 
We expect 20% of participants to be lost to follow-up. This dropout rate is conservative and has 
been found in many similar trials using NSPs and specialist delivered PTs for perinatal depression 
in the US and Canada24,39,53,54. Based on a Cochrane review73, numerous research on study 
retention (e.g.,74-76), and our previous experiences34,40,53,54, it is realistic to expect a 12-month 
post-randomization follow-up rate of at least 80% when we incorporate the following strategies:  
(1) Participant Strategies: We will complete qualitative interviews at the participant’s pace, 
allow flexibility with the interviews, design information material at a low reading level, and 
provide realistic expectations regarding study involvement. We will send quarterly 
newsletters to study participants with information that might be of interest or that 
participants may find useful, and reminders about questionnaire timelines (see SUMMIT 
Newsletter Template, Appendix E – pg 103). A small token of appreciation will be provided 
to all mothers ($15 USD/$20 CAD gift card) per completed assessment.  Upon completion 
of the 12-month questionnaire, participants will be entered in a raffle to receive a $100 
gift card.  The raffle will be held for every 100 participants who complete the 
questionnaire. Upon completion of the child assessment, participants will be provided a 
$40 token of appreciation. Participants reluctant to have RAs in their homes for the child 
assessment will have the option to complete the child assessment at the site hospital;  
(2) Tracking Strategies: REDCap™ will be used as a study-specific computerized tracking 
system to calculate follow-up dates. We will request permission from each participant for 
two secondary contacts (e.g., relative or friend) in the event that we lose contact with the 
participant.  In the event that we are not able to reach the participant and we reach out to 
a secondary contact, no information about the participant will be released to the 
secondary contact (see Secondary Contact Form, Appendix E – Study Documents, pg 83).  
We will verify and update contact information for the participant at each follow-up 
session.  Email or telephone reminders will be sent to participants prior to each 
appointment or assessment;  

30 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
(3) Personnel Strategies: All research staff will be trained and possess the following skills: (i) 
the capacity to communicate enthusiasm about the study; (ii) interpersonal persistence in 
a manner that is highly respectful; and (iii) a non-judgmental, empathic attitude. Research 
assistants will work flexible hours In order to accommodate telephone interviews at non-
standard times. We used these strategies in our previous prevention (retention = 85% at 
24 weeks postpartum) and treatment (retention = 87% at 36-weeks post-randomization) 
trials.  
3.3. Participant Withdrawal   
Participants can withdraw consent and end their participation in the study at any time. Non-
completers and patients who do not respond to treatment will be referred to a trial psychiatrist 
or referred pathway (family physician, OBGYN, or external psychiatric services). 
3.4.  Data Management  
3.4.1.  Quantitative Data. Quantitative data will be collected in identical REDCapTM databases 
kept on secure institutional servers within each of the three participating cities.  De-identified 
data from the US hubs will be extracted from the hub’s REDCapTM database, encrypted, and 
transferred to Toronto, where it will be uploaded, entered, and stored in REDCap™ hosted at 
The HUB: Health Research Solutions in the Li Ka Shing Knowledge Institute. REDCap™ is a 
secure, web-based application designed to support data capture for research studies, providing 
1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation 
and export procedures; 3) automated export procedures for seamless data downloads to 
common statistical packages; and 4) procedures for importing data from external sources.  Data 
collected via REDCap™ at The HUB, or uploaded to The HUB from US hubs, will be encrypted 
and stored on the local Storage Area Network (SAN) within St. Michael’s Hospital and will be 
backed up regularly and stored off-site. The data center is designed such that there are daily 
backups made of all critical data. In addition, the backups are stored both locally, as well as at a 
remote off-site location, in the case of catastrophic failure at one location. With limited access 
privileges, 24-hour security, and around-the-clock monitoring, the data center is highly secure. 
Upon providing informed consent, participants will be assigned a unique study ID.  Participants 
will receive emailed links to complete study assessments linked to their unique study ID profile 
in REDCap™. The cross walk for the study ID to personal information will be stored at each site 
in a password protected, encrypted file on a secure server within the institution.  Participants 
will be identified in REDCap™ by study ID only. REDCapTM will store participant emails in a 
separate server from the study data.  The emails will be inaccessible to study staff and 
protected against data export by being stored in a secure server in the REDCap backend, 
inaccessible to any study staff.  Treatment data will be collected by the provider, child 
assessments will be collected by trained research assistants, and all entered on the same 
REDCap™ system.  
 
3.4.2.  Qualitative Data. All study interviews and focus groups will be audio-recorded using a 
digital voice recorder.  

31 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
3.4.2.1. Qualitative Phase 1. Clinical Leads and Treatment Providers will be consented 
to the interviews and focus groups over the phone or a secure ZoomTM account from Toronto.  
All participants will be sent a link to their completed consent form in REDCapTM for their 
records.  A research staff person will arrange a time and call them to review the consent.  If 
they consent to participate, the research staff will ask them if they can record their consent.  
They will turn on the recorder, summarize the consent discussion, and ask the interviewee if 
they agree and consent.  Once they give recorded informed consent, the interview will begin. 
Interviews and focus groups with the Clinical Leads and Treatment Providers will be conducted 
from Toronto, either in-person or via ZoomTM—a secure and PHIPA-/HIPAA-compliant software 
used for remote communication.  The recording will be coded with the provider and supervisor 
ID and the date. No identifying information will be listed on the name of the file. Audio files will 
be transcribed and identifiers removed during transcription.  All study procedures for handling 
study audio-recorded data will be reviewed with study personnel every quarter to ensure that 
protocols are implemented with fidelity throughout the life of the study. Only approved 
research staff with a need to review or analyze data will have access.  
3.4.2.2. Qualitative Phase 2.  
Participants and significant others will be asked for informed consent, either in-person 
or over the phone or a secure ZoomTM account, by research staff at the site where they gave 
their consent to participate in the larger trial. Interviews and focus groups will be scheduled by 
the site where the participant gave their consent, and will be hosted over ZoomTM and 
conducted by an interviewer located in Toronto.  This will ensure that PHI does not leave each 
study though the interviewer may be located at a different site.  All study procedures for 
handling study audio-recorded data will be reviewed with study personnel every quarter to 
ensure that protocols are implemented with fidelity throughout the life of the study. Only 
approved research staff with a need to review or analyze data will have access.  
      
Stakeholders involved in the SUMMIT Trial (ie. Committee members, attendance at 
stakeholder meetings, etc.) will be invited via email to participate in a qualitative interview or 
focus group (see SUMMIT Stakeholder Email Interview Invite,  Appendix E – Study Documents, 
pg 61).  If they are interested, they will be consented by research staff in the hub nearest and 
most convenient to them, either in-person or over the phone or a secure ZoomTM account.  
Interviews will be conducted from Toronto either in-person or via ZoomTM—a secure and 
PHIPA-/HIPAA-compliant software used for remote communication.  The recording will be 
coded with the provider and supervisor ID and the date. No identifying information will be 
listed on the name of the file. Audio files will be transcribed and identifiers removed during 
transcription.  All study procedures for handling study audio-recorded data will be reviewed 
with study personnel every quarter to ensure that protocols are implemented with fidelity 
throughout the life of the study. Only approved research staff with a need to review or analyze 
data will have access. 
 
3.4.3. Audio-Recordings. Audio-recordings of BA sessions will be stored locally at each site and 
will adhere to local privacy and data management policies.  Audio-recordings may be securely 

32 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
transferred between sites within a hub to allow the clinical lead and independent consultant’s 
review.   
3.5.  Statistical Analyses  
3.5.1.  Primary Analysis.  Using SAS 9.4, primary analyses will be performed based on an intent-
to-treat basis. Two-sided significance levels of p<0.05 will be used for all analyses. Demographic 
(ethnicity, age, marital status) and other baseline variables (e.g., severity and chronicity) will be 
compared for potential differences between study groups using descriptive statistics (means, 
standard deviations, proportions) and the associated statistical tests (t-tests, chi-square tests). 
Those who drop out of the study will also be compared to those completing the study on 
baseline indices including maternal education and occupation. The primary outcome of non-
inferiority in EPDS scores will be compared between groups (telemedicine vs in-person, and 
specialist vs NSP) at 3-months using a t-test. The assessment period will be extended in the 
event that there is a hiatus to treatment due to significant perinatal-related life events (e.g., 
giving birth, obstetrical complications or COVID-19). One t-test will be run to assess this and 
compare modes (is telemedicine non-inferior to in-person). Another t-test will be run to assess 
this and compare agents (is non-specialist non-inferior to specialist). Each t-test will look at the 
confidence interval around the difference in EPDS scores (say between telemedicine and in-
person), and see if the upper bound contains the 10% (provider) or 13% (modality) non-
inferiority margin (upper bound for the case in which we take the difference to be telemedicine 
minus in-person).  We will conduct a sensitivity analysis to examine potential differences in 
baseline and outcome depressive symptoms and anxiety symptom scores to determine 
whether participants who were recruited and received treatment during the COVID-19 
outbreak differed significantly from the larger sample.  
In addition, we will run a linear regression model with mode, agent and a mode by agent 
interaction term to assess whether an interaction between mode and agent exists. In the 
unlikely event that randomization was not able to reduce bias by balancing out confounders, 
we will assess for confounding. This will be carried out by assessing each potential confounder 
individually in relation to the key predictor (mode or agent) and seeing if the potential 
confounder impacts the parameter estimate of the key predictor using the 10% change in 
estimate approach. The potential confounder would also need to be significantly related to the 
EPDS score outcome. Should any confounders exist, they’ll will be included in all of the 
previously mentioned analyses. Rules on the number of variables allowed in a multivariable 
model will be followed. The rule on number of variables in a linear regression is to take the 
total number of observations divided by 10. Given our trial sample size, we will not have any 
concerns with overfitting our linear model for our covariates of interest (education level, 
marital status, ethnicity, baseline severity and chronicity, timing of treatment, compliance, 
perceived support and medication). 
Our study statistician and two independent methodological consultants have reviewed 
and approved this plan of analysis. 
 
3.5.2.  Secondary Analysis.  In our secondary analysis, we are interested in: i) assessing the 
trend in EPDS scores over time (baseline, 3, 6- and 12-months post-randomization) between 

33 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
groups (telemedicine vs in-person, and specialist vs NSP). This will involve the use of linear 
mixed models adjusting for possible covariates including baseline depression symptoms, 
medication, treatment dosage, and child age when assessing child outcomes. Mothers will be 
taken as a random effect and the models will include a treatment- by- time interaction term; ii) 
the same set of analyses will be conducted for anxiety symptoms (GAD-7). All child outcomes, 
including child mental development and the provision of psychosocial stimulation by the 
mother, will be compared between two groups (antenatal vs. postnatal) at 6-24 months post-
childbirth using a two-sample two-sided t-test. Sensitivity analyses will be carried out excluding 
those who dropped out after first session to see if the results are comparable to the entire 
study group. No interim analyses will be carried out.  
 
3.5.3.  Subgroup Analyses.  Moderating effects will be conducted to determine whether 
delivery mode (telemedicine vs. in-person) or agent (specialist vs. non-specialist) have 
differential effects as a function of initial severity, whether mothers who receive antenatal 
treatment have lower depressive symptoms at 12-months post-enrollment than those who 
receive postnatal treatment; and whether children whose mothers receive the antenatal 
treatment have higher child development scores at 6-24 months post child birth than those 
children whose mothers receive postnatal treatment.   
3.5.3.1.  Clinical Severity.  Tests of moderation will be conducted to determine whether 
delivery mode (telemedicine vs. in-person) or agent (specialist vs. non-specialist) influence 
mothers who are severely depressed (EPDS>19)77. We expect 10 to 15% of our sample to be 
severely depressed (EPDS>19). A 2-group comparison with 75 per group and an assumed mean 
EPDS score of 20.0 (SD=7.0 77, will provide 80% power, with an alpha of 0.05, to detect a mean 
change of 2.3 or greater. Our current sample size including those within severity subgroups 
described above will be adequately powered to detect medium effect size differences of HTE of 
symptom severity between groups. This indicates that we have adequate power for clinically 
meaningful tests. The two groups’ (specialist vs non-specialist) EPDS scores at 3-months will be 
compared using a two-sided two-sample t-test. Change in EPDS score over time (baseline and 
every 3 months, post-randomization) will also be compared using linear mixed models. We will 
also examine this on anxiety symptoms at 3-months post randomization. 
 
3.5.3.2.  Perinatal Period. This model will also test whether expectant mothers who 
receive antenatal treatment benefit more in terms of reduced depressive symptoms than 
mothers who receive postnatal treatment at 12-months post-randomization. A 2-group 
comparison with 200 per group and an assumed mean of EPDS score of 7.93 (SD=4.68) will 
provide 90% power, with an alpha of 0.05, to detect a mean change of 1.5 points. This allows us 
to detect a drop corresponding to a small effect size of 0.3 (i.e., a drop to mean 6.43 on the 
EPDS). The two groups’ (antenatal vs. postnatal) EPDS scores at 3-months will be compared 
using a two-sided two-sample t-test. Change in EPDS scores over time (baseline and every 3 
months, post-randomization) also will be compared using linear mixed models including the 
interaction between group and time. We will examine anxiety symptoms at 12-months post 
randomization in a linear mixed model controlling for relevant covariates including child age.  
We will examine the hypothesis of whether the subset of mothers (up to 75% of the 
sample) who receive the antenatal treatment will benefit more in terms of improved child 

34 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
outcomes at 6-24 months than mothers who receive postnatal treatment. A 2-group 
comparison of 238 per group (antenatal vs. postnatal) and an assumed mean on any Bayley IV 
raw subscale score of 100, SD=15 to assess child mental development will provide 80% power, 
with an alpha of 0.05 to detect a mean clinically-significant change of 3.0 units. Raw and 
standardized Bayley IV scores of the two groups’ children (antenatal vs. postnatal) at 12 months 
will be compared using a two-sided, two-sample t-test. 
3.5.3.3.  Treatment Providers. Competency measures from the training sessions among 
both types of treatment providers (specialists and non-specialists) will be compared with 
participant outcomes to determine if competency scores during training predict participant 
outcomes.  Key variables related to competency will include treatment-specific skills (range 
mean score of 0-4) and general skills (range mean score of 0-4) as measured by the Q-HAP and 
a total score (range 0-35) of a 35-item multiple choice exam (range total score of 0-35). All 
analyses will be conducted using SAS 9.4.  Means, SDs and ranges of all competency measures 
for each individual NSP and across NSPs. This will be followed by estimating the relations 
between competency measures by calculating the Pearson correlation.  Finally, multiple 
regression analyses will be used to estimate whether competency measures can predict patient 
outcomes scores of EPDS and GAD-7 scores post-treatment. Covariates including baseline EPDS 
scores and treatment provider will be utilized to account for potential baseline heterogeneity.   
 
3.5.4.  Qualitative Analysis. All qualitative data will be analyzed using NVivo™, a qualitative 
data analysis software package. We will use content analysis with data analysis (coding) 
conducted by multiple independent raters, for whom inter-rater reliability will be calculated 
using Kappa (κ) scores. Coding will be conducted in a step-wise fashion to facilitate iterative 
revision and then finalization of a coding scheme. Specifically, there will be a process of first 
independently coding and then discussing a minimum of 3 cases per stakeholder group to 
achieve a kappa (κ) score of κ=0.75 or higher (defined as substantial to almost perfect 
agreement). Qualitative data will then be quantified and triangulated across stakeholder groups 
using our previously established methods21,78. 
 
3.5.5 Economic Evaluation Analysis.  Our economic evaluation will examine the cost-
effectiveness of non-specialist vs. specialist provider and telemedicine vs. in-person sessions (in 
line with the clinical analyses) and will follow CADTH guidelines 79. As such, we will adopt the 
health system perspective. 
3.5.5.1. Cost-effectiveness analyses. The primary economic evaluation will be a cost-
utility analysis (a cost-effectiveness analysis where outcomes are measured using a utility 
measure) carried out at the 12-month post-randomization follow-up point with outcomes 
expressed in terms of QALYs based on cases with non-missing data. Costs and outcomes will be 
compared at 12 months and will be presented as mean values by arm with standard deviations. 
Mean differences and 95% confidence intervals will be obtained by non-parametric bootstrap 
regressions to account for the non-normal distribution of the data80. A secondary analysis will 
be a cost-effectiveness analysis using the primary clinical outcome measure, the EPDS41 at 12-
months post-randomization. Cost-effectiveness will be assessed using the net benefit 
approach81 with reference to Bosmans’ methods for economic evaluations alongside 

35 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
equivalence or noninferiority trials82. Incremental cost-effectiveness ratios (ICERs) will be 
calculated, defined as the mean difference in cost between two groups divided by the mean 
difference in effect. Uncertainty will be explored using cost-effectiveness planes and cost-
effectiveness acceptability curves (CEACs) based on the net-benefit approach83. Cost-
effectiveness planes illustrate the uncertainty around the estimates of costs and effects by 
plotting the bootstrapped cost and effects, with points in each quadrant indicating a different 
implication for economic evaluation84. CEACs are an alternative to confidence intervals around 
ICERs and show the probability that one intervention is cost-effective compared to another, for 
a range of values that a decision maker would be willing to pay for a unit improvement in the 
outcome of interest83.  
3.5.6.2. Sensitivity and subgroup analyses. To explore the potential impact of excluding 
non-responders, we will examine the sociodemographic and clinical characteristics of those 
included in the analyses and those in the full sample. Further, we will rerun the primary and 
secondary cost-effectiveness analyses with missing total costs and outcomes imputed using 
multiple imputation by chained equations. We will explore the possibility of conducting 
subgroup analyses related to heterogeneity due to clinical severity and perinatal period 
(antenatal or postnatal), in line with proposed clinical analyses. We will examine geographic 
location by postal or zip code to explore the impact of location on various measures. 
 
3.5.6.  Missing Data. Strategies to reduce missing data have been discussed above. In addition, 
study staff will make at least four attempts to contact patients before recording their data as 
missing. Multiple imputation methods will be used when rates of missing data for a variable 
exceed 20%. Five imputed datasets will be created and the model results averaged across the 
five iterations. SAS’s Proc MI and Proc MIANALYZE will be used to carry out the procedures. 
Linear mixed models will be used to assess repeated measures outcomes. These models use 
maximum likelihood estimation methods that retain patients who do not have complete data 
across all time points. Reasons for dropout will be ascertained from clinician records or 
interviewing a subset of the participants who dropped out and coded. Sensitivity analyses will 
be carried out should missing data lead to the use of multiple imputation methods. These 
analyses will compare the results of the models on the imputed data to the ones with the actual 
missing data included. For the economic evaluation, participant health records will be accessed 
retrospectively to ensure that all health services accessed and costs incurred are captured.  In 
Toronto, we will work with the Institute for Clinical Evaluative Sciences (ICES) to collect these 
data. 
3.6.  Data Retention 
Study data will be kept for 10 years as per MSH REB recommendations and then destroyed 
following best practices.  

36 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
4     MONITORING 
4.1.  Data and Safety Monitoring Board 
The Data and Safety Monitoring Board (DSMB) will consist of four persons, including a 
psychiatrist with expertise in perinatal depressive or anxiety symptoms, a medical provider with 
expertise in providing obstetric care for pregnant women, a psychologist with expertise in the 
design and implementation of pragmatic clinical trials, and a PhD-level statistician. None of 
these persons will be involved directly in the study. The DSMB will have the following aims: 
• 
To assure the safety, privacy, and confidentiality of human subjects. 
• 
To assure the reliability, validity, completeness, and integrity of the data collection and 
management process. 
• 
To review implementation of the protection of human subjects protocol, including 
amendments made in relation to safety concerns. 
• 
To review all serious adverse events, rates of dropout or study withdrawal, and rates of 
missing data. 
 
4.2.  Reporting  
The Trial Steering Management (TSM) Subcommittee will present regular reports to the 
Advisory Committee, and the Data and Safety Monitoring Board. These include:  
• 
Monthly Recruitment Reports - reports of the number of women screened and enrolled by 
month and by clinical center are provided monthly to the TSM Subcommittee and all other 
members of the Steering Committee.  
• 
Quarterly Steering Committee Reports - reports detailing recruitment, baseline patient 
characteristics, data quality, missing data and protocol adherence by clinical center, are 
provided quarterly to the TSM Subcommittee and all members of the Steering Committee.  
• 
Data and Safety Monitoring Board Reports - a report will be prepared for every DSMB 
meeting that includes patient recruitment, baseline patient characteristics, center 
performance with respect to data quality, timeliness of data submission and protocol 
adherence (in addition to safety and efficacy data). The reports also include serious adverse 
events, loss to follow-up and all outcome variables as described previously in this protocol. 
4.3.  Serious Adverse Events  
Within 72 hours of a serious adverse event (SAE), the Trial Management Committee will report 
the event to the DSMB, including the details of the event, the severity of any reactions, the 
phase of the study, and the procedures for its resolution, and will report to the IRB of record 
(Appendix D – Adverse Events). In addition, the Project Administrator will ensure that the 
assigned PCORI program officer is informed of any actions taken by the IRB of record as a result 
of such events. The DSMB meet twice per year for the study duration. Members will also meet 
via conference calls if SAEs attributable to study procedures are reported. 

37 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
4.4.  Safety Protocols  
Safety protocols for both the recruitment research assistant and the treatment provider have 
been adapted from previous studies54 (detailed in Appendix A –Safety Protocols and Forms). In 
brief, a multistep process will be followed: 
● Monitoring treatment quality.  BA delivery will be extensively monitored during the study 
using previously established methods developed and tested by the PI.   
⮚ Training Phase. During the training phase, clinical leads will host weekly supervision 
meetings with NSPs and specialist providers to review and discuss cases and 
reinforce BA training.  Independent consultants will evaluate treatment among 5% 
of all audio sessions to assess treatment adherence and fidelity. Treatment providers 
not reaching the mean cut-off for specific items will receive refresher training by the 
study clinicians. In addition, quality indicators of NSP and specialist-delivered 
sessions will be collected including the number, mode of delivery and duration of 
sessions.  
⮚ Trial Phase. During the trial phase, NSPs will continue to attend weekly supervision 
meetings to review and discuss cases.  Once per month, clinical leads and NSPs will 
rate individual audio-recorded sessions for therapy quality—the extent to which a 
psychological treatment was implemented well enough to achieve its expected 
effects85—of audio-recorded sessions in a monthly structured supervision. Audio 
recordings will be rated using the 20-item Q-HAP52 for BA-treatment-specific and 
common (e.g., collaboration, empathy) skills. The individual NSP who conducted the 
session (self-rating), two to three peers (peer ratings) and a clinical lead (expert 
rating) will rate each session. The summed score for each subscale will be used to 
estimate therapy quality for each NSP and compared to expert ratings.  Specialists 
will not attend regular supervision, but supervision will be available to them on an 
ad hoc basis to reflect real-world conditions.  
⮚ Independent consultants will continue to evaluate treatment among 5% of all audio 
sessions, by both NSPs and specialists, to assess treatment adherence and fidelity. 
Treatment providers not reaching the mean cut-off for specific items will receive 
refresher training by the study clinicians. 
● Notification and Plan for Severe Session-Wise Scores. Depression scores on the EPDS will 
be assessed at the beginning of each session. Any mother who has a positive response on 
the self-harm ideation item will undergo the standard safety protocol and in the case of 
active suicidal ideation, will be further assessed by a trial perinatal psychiatrist or associated 
Emergency Department for further assessment as is currently in practice at each of our 
three hubs. Women with worsening symptom scores on post-baseline EPDS session-by-
session assessments during the intervention phase will be reviewed by the study team who 
will follow up on each case individually to provide recommendations about referral to 
additional psychiatric care if clinically indicated, including recommendations around a need 
for emergency assessment. 24-hr emergency psychiatric care is available at each hub. For 
concerns about maternal self-harm or infant/child harm that arise during the intervention, 

38 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
the provider will follow an established protocol, used effectively in our previous trials24,53,54, 
which will be supervised by the site trial psychiatrist (Appendix A –Safety Protocols and 
Forms).  
● Post-Intervention Protocols.  If a participant has an EPDS >12 at the post-treatment 
outcome assessment or at any subsequent assessment, the participant’s most responsible 
provider (e.g. midwife, obstetrician, family physician or psychiatrist) will be informed by the 
research team and, if the participant is not already enrolled in care with a perinatal mental 
health team, information will be given for how to initiate referral to additional specialty 
psychiatric care with the participant’s consent.  For concerns about maternal self-harm or 
infant/child harm that arise during the follow-up period, we will follow an established 
protocol, used effectively in our previous trials24,53,54, which will be supervised by the trial 
psychiatrist at each site (Appendix A –Safety Protocols and Forms).  
● Extensive Training.  All providers, including specialists will have completed an extensive 
training program focused on the development and evaluation of core competencies in BA 
and common counseling skills, followed by weekly supervision with a clinical lead.  
● Negative Intervention Effects will be assessed for through regular evaluations on a monthly 
basis by our research team including Serious Adverse Events (SAE’s).  
● Measuring Child Outcomes. Trained research assistants will conduct post-child birth 
assessments (months 6-24) as per hospital protocols for conducting home visits.  
● Informing the Patient’s Provider. With participant consent (see Participation in SUMMIT 
Health Care Provider Fax/Email Template, Appendix E – Study Documents, pg. 101), we will 
inform the patient’s regular provider with the results of screening (i.e., EPDS score and 
eligibility into SUMMIT) via electronic message (using the electronic health record when 
available) or via fax or mailed letter. We also will communicate with the patient’s provider 
at the end of the study for each participant with a letter summarizing all follow-up and 
management strategies implemented and final symptomatology results.  All provider 
information will be kept on site in an encrypted file on a secure server and linked to the 
participant by Study ID.  We have completed these interdisciplinary communication 
strategies before with no difficulties in previous maternal depression trials24,53,86,87. 
● Incidental Findings. If any unexpected, clinically important information about a participant’s 
or their child’s health is suspected, the study team may contact them to make them aware 
of that information. The Site PI will review the information, consult with specialists if 
needed while protecting the participant’s identity, and determine whether the participant 
should be contacted and informed. 
5  
ETHICS AND DISSEMINATION 
5.1.  Research Ethics Approval  
In Toronto, we will seek ethical approval from Clinical Trials Ontario (CTO) Stream —a system 
that allows one CTO-Qualified Research Ethics Board (REB) to oversee the ethical approval and 
conduct of research occurring at multiple sites in Ontario, streamlining the REB application 
process (SHS, SMH, and WCH).  In North Carolina, we will seek ethical approval from the UNC 
Biomedical Institution Review Board. In Chicago, we will seek ethical approval from the 

39 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Institutional Review Board of NorthShore University HealthSystems, which provides approval 
across all NorthShore-affiliated study sites. We will submit for approval after receiving input on 
the current protocol following our first Stakeholder Advisory Committee meeting in May 2019.  
5.2.  Protocol Amendments  
Any modifications to the protocol that may impact study conduct, potentially benefit patients 
or affect their safety, including changes of study objectives, study design, patient population, 
sample sizes, study procedures, or significant administrative aspects will require a formal 
amendment to the protocol. Such amendment will be agreed upon by the TSM and approved 
by the REB/IRB (Institutional Review Board) prior to implementation and to the health 
authorities notified in accordance with local regulations. Amendments in relation to safety 
concerns will also be reviewed by the DSMB prior to implementation.  Administrative changes 
are minor corrections or clarifications that have no effect on the way the study is to be 
conducted. These administrative changes will be agreed upon by TSM, and will be documented 
in a memorandum. The REB/IRB will be notified of administrative changes as necessary. 
 
5.3.  Confidentiality   
To ensure confidentiality, data dispersed to relevant team members (including the PI and study 
biostatistician) will be blinded of any identifying participant information and treatment 
allocation.  Only the site recruitment research assistants, research assistants responsible for 
scheduling appointments, and treatment providers will have access to the identifying 
participant information. All information will be kept in password-protected, encrypted files on 
encrypted computers and secure servers. Unique Study IDs will be used to identify the 
participants with Key Files kept at the site from which the participant was recruited.  The Key 
File will be encrypted and stored on an encrypted computer or a secure server within each trial 
site institution. 
5.4.  Declaration of Interests 
There are no conflicts of interest. 
 
5.5.  Data Management  
The Data Manager will oversee the intra-study data sharing process, with input from the Trial 
Steering Committee. The PI and study biostatistician will be given access to the cleaned data 
sets. Quantitative data will be collected via REDCapTM at each hub separately, exported, 
encrypted and securely transferred to Toronto, where it will be housed in encrypted files on the 
local Storage Area Network (SAN) within St. Michael’s Hospital, and will be backed up regularly 
and stored off-site. The data center is designed such that there are daily backups made of all 
critical data. In addition, the backups are stored both locally, as well as at a remote off-site 
location, in the case of catastrophic failure at one location. With limited access privileges, 24-
hour security, and around-the-clock monitoring, the data center is highly secure.   Qualitative 
data, as well as audio-recorded sessions, will be saved as de-identified transcribed interviews 
and stored in encrypted files on an encrypted computer within each hub. The site PIs will have 
direct access to their own site’s data and may have access to other sites’ data by request.  

40 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
5.6.  Testimonials 
As a part of the dissemination phase of the trial, we will ask some participants, significant 
others, and treatment providers who have consented to be contacted to participate in 
qualitative interviews, offered to provide testimonies based on previous visits, and/or to be 
contacted for future research, if they would like to provide testimonials about their experiences 
with the SUMMIT Trial. These testimonials will be used for SUMMIT dissemination and 
knowledge mobilization purposes, and may include text quotes and/or or audio-visual materials 
such as photos, audio or voice. Those participants, significant others, and treatment providers 
who would like to provide testimonials will be provided with the opportunity to consent to, or 
not consent to, each specific type of testimonial (i.e., text, photos, audio, video). They will be 
made aware that publication of these testimonials may appear in media available to the public, 
for example in newsletters, brochures, websites and videos, and will also be informed of the 
potential risks involved (see ICF Testimonial Addenda, Appendix E – Study Documents, pg. 41 – 
56).  
 

41 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
6   REFERENCES 
 
1. 
Ferrari AJ, Charlson FJ, Norman RE, et al. Burden of depressive disorders by country, sex, 
age, and year: findings from the global burden of disease study 2010. PLoS Med. 
2013;10(11):e1001547.  
2. 
O'hara MW, Swain AM. Rates and risk of postpartum depression—a meta-analysis. 
International review of psychiatry. 1996;8(1):37-54.  
3. 
Wisner KL, Sit DKY, McShea MC, et al. Onset Timing, Thoughts of Self-harm, and 
Diagnoses in Postpartum Women With Screen-Positive Depression Findings. JAMA psychiatry. 
2013;70(5):490-498. doi:10.1001/jamapsychiatry.2013.87 
4. 
Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum 
depression: a synthesis of recent literature. General Hospital Psychiatry. 7// 2004;26(4):289-
295. doi:https://doi.org/10.1016/j.genhosppsych.2004.02.006 
5. 
Bauer A, Knapp M, Parsonage M. Lifetime costs of perinatal anxiety and depression. 
Journal of affective disorders. 2016;192:83-90.  
6. 
Dennis C-L, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: 
systematic review and meta-analysis. The British Journal of Psychiatry. 2017:bjp. bp. 
116.187179.  
7. 
Falah-Hassani K, Shiri R, Dennis C-L. Prevalence and risk factors for comorbid 
postpartum depressive symptomatology and anxiety. Journal of affective disorders. 
2016;198:142-147.  
8. 
Stein A, Pearson RM, Goodman SH, et al. Effects of perinatal mental disorders on the 
fetus and child. The Lancet. 2014;384(9956):1800-1819.  
9. 
Field T. Prenatal depression effects on early development: a review. Infant Behav Dev. 
Feb 2011;34(1):1-14. doi:10.1016/j.infbeh.2010.09.008 
10. 
Meltzer-Brody S, Howard LM, Bergink V, et al. Postpartum psychiatric disorders. Nat Rev 
Dis Primers. Apr 26 2018;4:18022. doi:10.1038/nrdp.2018.22 
11. 
Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal 
depression. Clinical psychology review. 2011;31(5):839-849.  
12. 
O'hara MW, McCabe JE. Postpartum depression: current status and future directions. 
Annual review of clinical psychology. 2013;9:379-407.  
13. 
Goodman JH. Women’s attitudes, preferences, and perceived barriers to treatment for 
perinatal depression. Birth. 2009;36(1):60-69.  
14. 
O'Mahen HA, Flynn HA. Preferences and perceived barriers to treatment for depression 
during the perinatal period. Journal of women's health. 2008;17(8):1301-1309.  
15. 
Byatt N, Xiao RS, Dinh KH, Waring ME. Mental health care use in relation to depressive 
symptoms among pregnant women in the USA. Archives of women's mental health. 
2016;19(1):187-191.  
16. 
Dennis CL, Chung‐Lee L. Postpartum depression help‐seeking barriers and maternal 
treatment preferences: A qualitative systematic review. Birth. 2006;33(4):323-331.  
17. 
O'Connor E, Rossom RC, Henninger M, Groom HC, Burda BU. Primary Care Screening for 
and Treatment of Depression in Pregnant and Postpartum Women: Evidence Report and 

42 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
Systematic Review for the US Preventive Services Task Force. Jama. Jan 26 2016;315(4):388-
406. doi:10.1001/jama.2015.18948 
18. 
Curry SJ, Krist AH, Owens DK, et al. Interventions to Prevent Perinatal Depression: US 
Preventive Services Task Force Recommendation Statement. Jama. 2019;321(6):580-587.  
19. 
Singla DR, Kohrt B, Murray LK, Anand A, Chorpita BF, Patel V. Psychological treatments 
for the world: lessons from low-and middle-income countries. Annual Review of Clinical 
Psychology. 2017;13(1) 
20. 
Hoeft TJ, Fortney JC, Patel V, Unützer J. Task‐Sharing Approaches to Improve Mental 
Health Care in Rural and Other Low‐Resource Settings: A Systematic Review. The Journal of 
rural health. 2016; 
21. 
Singla D, Lazarus A, Atif N, et al. “Someone like us”: Delivering maternal mental health 
through peers in two South Asian contexts. Journal of affective disorders. 2014;168:452-458.  
22. 
O'Mahen HA, Grieve H, Jones J, McGinley J, Woodford J, Wilkinson EL. Women's 
experiences of factors affecting treatment engagement and adherence in internet delivered 
Behavioural Activation for Postnatal Depression. Internet Interventions. 2015;2(1):84-90.  
23. 
Patel V, Weobong B, Weiss HA, et al. The Healthy Activity Program (HAP), a lay 
counsellor-delivered brief psychological treatment for severe depression, in primary care in 
India: a randomised controlled trial. The Lancet. 2017;389(10065):176-185.  
24. 
Dimidjian S, Goodman SH, Sherwood NE, et al. A pragmatic randomized clinical trial of 
behavioral activation for depressed pregnant women. Journal of Consulting and Clinical 
Psychology. 2017;85(1):26.  
25. 
Dimidjian S, Hollon SD, Dobson KS, et al. Randomized trial of behavioral activation, 
cognitive therapy, and antidepressant medication in the acute treatment of adults with major 
depression. Journal of consulting and clinical psychology. 2006;74(4):658.  
26. 
Dobson KS, Hollon SD, Dimidjian S, et al. Randomized trial of behavioral activation, 
cognitive therapy, and antidepressant medication in the prevention of relapse and recurrence 
in major depression. Journal of consulting and clinical psychology. 2008;76(3):468.  
27. 
Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and 
treatment of perinatal mood disorders: a systematic review. BMC pregnancy and childbirth. 
2016;16(1):38.  
28. 
Andrews G. Utility of computerised cognitive–behavioural therapy for depression. The 
British Journal of Psychiatry. 2010;196(4):257-258.  
29. 
Lokkerbol J, Adema D, Cuijpers P, et al. Improving the cost-effectiveness of a healthcare 
system for depressive disorders by implementing telemedicine: a health economic modeling 
study. The American Journal of Geriatric Psychiatry. 2014;22(3):253-262.  
30. 
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety 
and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PloS 
one. 2010;5(10):e13196.  
31. 
Singla DR, Raviola G, Patel V. Scaling up psychological treatments for common mental 
disorders: a call to action. World Psychiatry. in press; 
32. 
Dimidjian S, Barrera Jr M, Martell C, Muñoz RF, Lewinsohn PM. The origins and current 
status of behavioral activation treatments for depression. Annual Review of Clinical Psychology. 
2011;7:1-38.  

43 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
33. 
Jacobson NS, Martell CR, Dimidjian S. Behavioral activation treatment for depression: 
Returning to contextual roots. Clinical Psychology: science and practice. 2001;8(3):255-270.  
34. 
Weobong B, Weiss HA, McDaid D, et al. Sustained effectiveness and cost-effectiveness 
of the Healthy Activity Program, a brief psychological treatment for depression delivered by lay 
counsellors in primary care: twelve-month follow-up of a randomised controlled trial. PLoS 
Medicine. 2017;17(9) 
35. 
Cuijpers P, Van Straten A, Warmerdam L. Behavioral activation treatments of 
depression: A meta-analysis. Clinical psychology review. 2007;27(3):318-326.  
36. 
Mazzucchelli T, Kane R, Rees C. Behavioral activation treatments for depression in 
adults: a meta‐analysis and review. Clinical Psychology: Science and Practice. 2009;16(4):383-
411.  
37. 
Richards DA, Ekers D, McMillan D, et al. Behavioural Therapy for Depression (COBRA): a 
randomised, controlled, non-inferiority trial. 2016; 
38. 
Dimidjian S, Goodman SH. Preferences and attitudes toward approaches to depression 
relapse/recurrence prevention among pregnant women. Behaviour research and therapy. 
2014;54:7-11.  
39. 
O'mahen H, Richards D, Woodford J, et al. Netmums: a phase II randomized controlled 
trial of a guided Internet behavioural activation treatment for postpartum depression. 
Psychological medicine. 2014;44(08):1675-1689.  
40. 
Singla DR, Kumbakumba E, Aboud FE. Effects of a parenting intervention to address 
maternal psychological wellbeing and child development and growth in rural Uganda: a 
community-based, cluster-randomised trial. The Lancet Global Health. 2015;3(8):e458-e469.  
41. 
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 
10-item Edinburgh Postnatal Depression Scale. The British journal of psychiatry. 
1987;150(6):782-786.  
42. 
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized 
anxiety disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-1097.  
43. 
O'Mahen HA, Richards DA, Woodford J, et al. Netmums: a phase II randomized 
controlled trial of a guided Internet behavioural activation treatment for postpartum 
depression. Psychol Med. Jun 2014;44(8):1675-89. doi:10.1017/S0033291713002092 
44. 
Posner K, Brent D, Lucas C, et al. Columbia-suicide severity rating scale (C-SSRS). New 
York, NY: Columbia University Medical Center. 2008; 
45. 
Kim JJ, La Porte LM, Saleh MP, et al. Suicide risk among perinatal women who report 
thoughts of self-harm on depression screens. Obstetrics & Gynecology. 2015;125(4):885-893.  
46. 
Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric 
Interview (MINI): the development and validation of a structured diagnostic psychiatric 
interview for DSM-IV and ICD-10. The Journal of clinical psychiatry. 1998; 
47. 
Kimmel MC, Lara-Cinisomo S, Melvin K, Di Florio A, Brandon A, Meltzer-Brody S. 
Treatment of severe perinatal mood disorders on a specialized perinatal psychiatry inpatient 
unit. Archives of women's mental health. 2016;19(4):645-653.  
48. 
Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG. The alcohol use disorders 
identification test. Guidelines for use in primary health care Geneva: World Health Organization. 
1992; 

44 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
49. 
Maisto SA, Carey MP, Carey KB, Gordon CM, Gleason JR. Use of the AUDIT and the 
DAST-10 to identify alcohol and drug use disorders among adults with a severe and persistent 
mental illness. Psychological assessment. 2000;12(2):186.  
50. 
Staley D, El-Guebaly N. Psychometric properties of the Drug Abuse Screening Test in a 
psychiatric patient population. Addictive Behaviors. 1990;15(3):257-264.  
51. 
Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. A single-question screening test 
for drug use in primary care. Archives of internal medicine. 2010;170(13):1155-1160.  
52. 
Singla DR, Weobong B, Nadkarni A, et al. Improving the scalability of psychological 
treatments in developing countries: an evaluation of peer-led therapy quality assessment in 
Goa, India. Behaviour research and therapy. 2014;60:53-59.  
53. 
Dennis C-L, Hodnett E, Kenton L, et al. Effect of peer support on prevention of postnatal 
depression among high risk women: multisite randomised controlled trial. Bmj. 
2009;338:a3064.  
54. 
Dennis C-L, Ravitz P, Grigoriadis S, et al. The effect of telephone-based interpersonal 
psychotherapy for the treatment of postpartum depression: study protocol for a randomized 
controlled trial. Trials. 2012;13(1):38.  
55. 
Spitzer RL, Kroenke K, Williams JB, Group PHQPCS. Validation and utility of a self-report 
version of PRIME-MD: the PHQ primary care study. Jama. 1999;282(18):1737-1744.  
56. 
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The multidimensional scale of perceived 
social support. Journal of personality assessment. 1988;52(1):30-41.  
57. 
Üstün TB, Chatterji S, Kostanjsek N, et al. Developing the World Health Organization 
disability assessment schedule 2.0. Bulletin of the World Health Organization. 2010;88:815-823.  
58. 
Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new 
five-level version of EQ-5D (EQ-5D-5L). Quality of Life Research. 2011-12-01 2011;20(10):1727-
1736. doi:10.1007/s11136-011-9903-x 
59. 
Lang AJ, Stein MB. An abbreviated PTSD checklist for use as a screening instrument in 
primary care. Behaviour research and therapy. 2005;43(5):585-594.  
60. 
Singla DR, MacKinnon DP, Fuhr DC, Sikander S, Rahman A, Patel V. Multiple mediation 
analysis of the peer-delivered Thinking Healthy Programme for perinatal depression: findings 
from two parallel, randomised controlled trials. The British Journal of Psychiatry. 2019:1-8.  
61. 
Attkisson CC, Zwick R. The Client Satisfaction Questionnaire: Psychometric properties 
and correlations with service utilization and psychotherapy outcome. Evaluation and program 
planning. 1982;5(3):233-237.  
62. 
Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short 
Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol 
Psychother. May-Jun 2010;17(3):231-9. doi:10.1002/cpp.658 
63. 
Brown G. Health service utilization and cost of care questionnaire. Health and Social 
Service Utilization Research Unit Hamilton, ON: McMaster University. 2001; 
64. 
Fuhr DC, Calvert C, Ronsmans C, et al. Contribution of suicide and injuries to pregnancy-
related mortality in low-income and middle-income countries: a systematic review and meta-
analysis. Lancet Psychiatry. Aug 2014;1(3):213-25. doi:10.1016/s2215-0366(14)70282-2 
65. 
Bradley RH, Caldwell BM. The HOME Inventory and family demographics. 
Developmental Psychology. 1984;20(2):315.  

45 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
66. 
Bayley N, Aylward G. Bayley scales of infant and toddler development. 4 edn ed. MN: 
NCS Pearson, Inc; 2019. 
67. 
Aboud FE, Singla DR. Challenges to changing health behaviours in developing countries: 
a critical overview. Social science & medicine. 2012;75(4):589-594.  
68. 
Singla DR, Hollon SD, Velleman R, et al. Temporal pathways of change in two 
randomized controlled trials for depression and harmful drinking in Goa, India. Psychological 
Medicine. 2019:1-9. doi:10.1017/S0033291718003963 
69. 
Trevillion K, Ryan E, Pickles A, et al. An exploratory parallel-group randomised controlled 
trial of antenatal Guided Self-Help (plus usual care) versus usual care alone for pregnant 
women with depression: DAWN trial. Journal of affective disorders. 2020;261:187-197.  
70. 
Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the 
economic evaluation of health care programmes. Oxford university press; 2015. 
71. 
Wodchis WP, Bushmeneva K, Nikitovic M, McKillop I. Guidelines on person-level costing 
using administrative databases in Ontario. 2013; 
72. 
Pollack LM, Chen J, Cox S, et al. Healthcare Utilization and Costs Associated With 
Perinatal Depression Among Medicaid Enrollees. American Journal of Preventive Medicine. 
2022/02/25/ 2022;doi:https://doi.org/10.1016/j.amepre.2021.12.008 
73. 
Edwards P, Roberts I, Clarke M, et al. Methods to influence response to postal 
questionnaires. The Cochrane Library. 2001; 
74. 
Seed M, Juarez M, Alnatour R. Improving recruitment and retention rates in preventive 
longitudinal research with adolescent mothers. Journal of Child and Adolescent Psychiatric 
Nursing. 2009;22(3):150-153.  
75. 
Hough RL, Tarke H, Renker V, Shields P, Glatstein J. Recruitment and retention of 
homeless mentally ill participants in research. Journal of consulting and clinical psychology. 
1996;64(5):881.  
76. 
Katz KS, El-Mohandes A, Johnson DM, Jarrett M, Rose A, Cober M. Retention of low 
income mothers in a parenting intervention study. Journal of Community Health. 
2001;26(3):203-218.  
77. 
McCabe-Beane JE, Segre LS, Perkhounkova Y, Stuart S, O’Hara MW. The identification of 
severity ranges for the Edinburgh Postnatal Depression Scale. Journal of Reproductive and 
Infant Psychology. 2016;34(3):293-303.  
78. 
Singla DR, Kumbakumba E. The development and implementation of a theory-informed, 
integrated mother-child intervention in rural Uganda. Social Science & Medicine. 2015;147:242-
251.  
79. 
Drugs CAf, Health Ti. Guidelines for the economic evaluation of health technologies: 
Canada. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2006. 
80. 
Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the 
non‐parametric bootstrap. Statistics in medicine. 2000;19(23):3219-3236.  
81. 
Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of 
uncertainty in cost-effectiveness analysis. Medical decision making. 1998;18(2_suppl):S68-S80.  
82. 
Bosmans JE, De Bruijne MC, Van Hout HP, Hermens ML, Adèr HJ, Van Tulder MW. 
Practical guidelines for economic evaluations alongside equivalence trials. Value in Health. 
2008;11(2):251-258.  

46 
 
SUMMIT Protocol V20: 25 Oct 2024 
 
 
 
 
 
 
 
83. 
Briggs AH. A Bayesian approach to stochastic cost‐effectiveness analysis. Health 
economics. 1999;8(3):257-261.  
84. 
Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. The British 
Journal of Psychiatry. 2005;187(2):106-108.  
85. 
Fairburn CG, Cooper Z. Therapist competence, therapy quality, and therapist training. 
Behaviour Research and Therapy. 2011;49(6):373-378.  
86. 
Sikander S, Lazarus A, Bangash O, et al. The effectiveness and cost-effectiveness of the 
peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the 
SHARE study protocol for randomised controlled trials. Trials. 2015;16(1):534.  
87. 
Fuhr DC, Weobong B, Lazarus A, et al. Delivering the Thinking Healthy Programme for 
perinatal depression through peers: an individually- randomised controlled trial in India. The 
Lancet Psychiatry. 2019;6(2):115-127.