Trial Outcomes & Findings for Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT) (NCT NCT04153864)

Last Updated: 2025-08-14

Results Overview

Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

1230 participants

Primary outcome timeframe

3-months post-randomization

Results posted on

2025-08-14

Participant Flow

Participants were recruited from January 2020 to October 2023 from five clinical sites (Mount Sinai Hospital, Women's College Hospital, St. Michael's Hospital, University of North Carolina and Endeavor Health).

A total of 3,629 individuals were approached. 1,543 agreed to participate by completing the consent form and 1,512 completed a second, more detailed screening. A total of 1,230 participants were enrolled and randomized into the trial.

Participant milestones

Participant milestones
Measure	Arm 1: Telemedicine Non-Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider.	Arm 2: In-Person Non-Specialist The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider	Arm 3: Telemedicine Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider.	Arm 4: In-Person Specialist The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider.
Overall Study STARTED	472	145	469	144
Overall Study COMPLETED	419	128	417	134
Overall Study NOT COMPLETED	53	17	52	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Telemedicine Non-Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider.	Arm 2: In-Person Non-Specialist The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider	Arm 3: Telemedicine Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider.	Arm 4: In-Person Specialist The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider.
Overall Study Withdrawal by Subject	21	7	23	2
Overall Study Lost to Follow-up	4	0	3	0
Overall Study Did not complete 3-month follow-up assessment but continued in the trial	28	10	26	8

Baseline Characteristics

Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Telemedicine Non-Specialist n=472 Participants The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider.	Arm 2: In-Person Non-Specialist n=145 Participants The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider	Arm 3: Telemedicine Specialist n=469 Participants The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider.	Arm 4: In-Person Specialist n=144 Participants The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider.	Total n=1230 Participants Total of all reporting groups
Age, Continuous	33.08 years STANDARD_DEVIATION 5.10 • n=471 Participants • Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3	33.84 years STANDARD_DEVIATION 4.79 • n=145 Participants • Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3	33.04 years STANDARD_DEVIATION 4.79 • n=466 Participants • Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3	34.10 years STANDARD_DEVIATION 5.01 • n=144 Participants • Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3	33.27 years STANDARD_DEVIATION 4.95 • n=1226 Participants • Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3
Sex/Gender, Customized Female	441 Participants n=472 Participants	144 Participants n=145 Participants	440 Participants n=469 Participants	143 Participants n=144 Participants	1168 Participants n=1230 Participants
Sex/Gender, Customized Different Identity	1 Participants n=472 Participants	0 Participants n=145 Participants	0 Participants n=469 Participants	0 Participants n=144 Participants	1 Participants n=1230 Participants
Sex/Gender, Customized Genderqueer/Gender non-confirming	2 Participants n=472 Participants	0 Participants n=145 Participants	0 Participants n=469 Participants	0 Participants n=144 Participants	2 Participants n=1230 Participants
Sex/Gender, Customized Prefer not to answer	1 Participants n=472 Participants	0 Participants n=145 Participants	1 Participants n=469 Participants	0 Participants n=144 Participants	2 Participants n=1230 Participants
Sex/Gender, Customized Not reported	27 Participants n=472 Participants	1 Participants n=145 Participants	28 Participants n=469 Participants	1 Participants n=144 Participants	57 Participants n=1230 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=472 Participants	0 Participants n=145 Participants	3 Participants n=469 Participants	1 Participants n=144 Participants	5 Participants n=1230 Participants
Race/Ethnicity, Customized Asian	87 Participants n=472 Participants	27 Participants n=145 Participants	73 Participants n=469 Participants	22 Participants n=144 Participants	209 Participants n=1230 Participants
Race/Ethnicity, Customized Black/African American	40 Participants n=472 Participants	19 Participants n=145 Participants	46 Participants n=469 Participants	19 Participants n=144 Participants	124 Participants n=1230 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	1 Participants n=472 Participants	1 Participants n=145 Participants	1 Participants n=469 Participants	1 Participants n=144 Participants	4 Participants n=1230 Participants
Race/Ethnicity, Customized White	242 Participants n=472 Participants	69 Participants n=145 Participants	231 Participants n=469 Participants	72 Participants n=144 Participants	614 Participants n=1230 Participants
Race/Ethnicity, Customized Multi-race	34 Participants n=472 Participants	10 Participants n=145 Participants	45 Participants n=469 Participants	11 Participants n=144 Participants	100 Participants n=1230 Participants
Race/Ethnicity, Customized Hispanic (Latino/Latina)	38 Participants n=472 Participants	10 Participants n=145 Participants	39 Participants n=469 Participants	14 Participants n=144 Participants	101 Participants n=1230 Participants
Race/Ethnicity, Customized Other	15 Participants n=472 Participants	4 Participants n=145 Participants	14 Participants n=469 Participants	2 Participants n=144 Participants	35 Participants n=1230 Participants
Race/Ethnicity, Customized Prefer not to answer	13 Participants n=472 Participants	5 Participants n=145 Participants	14 Participants n=469 Participants	2 Participants n=144 Participants	34 Participants n=1230 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=472 Participants	0 Participants n=145 Participants	3 Participants n=469 Participants	0 Participants n=144 Participants	4 Participants n=1230 Participants
Baseline EPDS	15.63 units on a scale STANDARD_DEVIATION 3.76 • n=472 Participants	15.68 units on a scale STANDARD_DEVIATION 3.83 • n=145 Participants	15.96 units on a scale STANDARD_DEVIATION 3.92 • n=469 Participants	15.72 units on a scale STANDARD_DEVIATION 3.96 • n=144 Participants	15.77 units on a scale STANDARD_DEVIATION 3.85 • n=1230 Participants
Baseline GAD-7	11.92 units on a scale STANDARD_DEVIATION 4.76 • n=472 Participants	12.00 units on a scale STANDARD_DEVIATION 4.54 • n=145 Participants	11.72 units on a scale STANDARD_DEVIATION 5.11 • n=469 Participants	11.87 units on a scale STANDARD_DEVIATION 5.08 • n=144 Participants	11.85 units on a scale STANDARD_DEVIATION 4.90 • n=1230 Participants

PRIMARY outcome

Timeframe: 3-months post-randomization

Population: 1\. The groups shown below are non-mutually exclusive, as participants were included in two arms (as reflected in the four arms described in the Participant Flow table). This overlap occurred because the study used a 2 × 2 factorial design, in which participants simultaneously received a combination of two interventions.

Outcome measures

Outcome measures
Measure	Non-Specialist n=547 Participants Trained non-mental health providers (e.g., registered nurses, midwives and doulas) without formal training in mental health care or previous experience delivering psychological treatments.	Specialist n=551 Participants Psychiatrists, psychologists and social workers with a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment	Telemedicine n=836 Participants A brief, manualized behavioral activation treatment delivered over a secure HIPPA/PHIPPA compliant audio-visual digital platform (i.e., Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in Chicago)	In-Person n=262 Participants A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within Toronto, Chapel Hill and Chicago
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score	9.27 score on a scale Interval 8.85 to 9.7	8.91 score on a scale Interval 8.49 to 9.33	9.15 score on a scale Interval 8.79 to 9.5	8.92 score on a scale Interval 8.38 to 9.45

SECONDARY outcome

Timeframe: 6- and 12-months post-randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-months post-randomization

Population: 1. The groups shown below are non-mutually exclusive, as participants were included in two arms (the four arms described in the Participant Flow table). This overlap occurred because the study used a 2 × 2 factorial design, in which participants simultaneously received combinations of two interventions. 2. At 3-months post-randomization, GAD-7 data were missing for some participants; the numbers presented above reflect only those with available data and used for analysis.

Generalized Anxiety Disorder (GAD-7) is a brief, 7-item self-administered questionnaire used to screen for and assess the anxiety symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-21. Higher GAD-7 total scores indicates a greater severity of anxiety symptoms.

Outcome measures

Outcome measures
Measure	Non-Specialist n=545 Participants Trained non-mental health providers (e.g., registered nurses, midwives and doulas) without formal training in mental health care or previous experience delivering psychological treatments.	Specialist n=550 Participants Psychiatrists, psychologists and social workers with a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment	Telemedicine n=834 Participants A brief, manualized behavioral activation treatment delivered over a secure HIPPA/PHIPPA compliant audio-visual digital platform (i.e., Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in Chicago)	In-Person n=261 Participants A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within Toronto, Chapel Hill and Chicago
Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score	6.44 units on a scale Interval 6.01 to 6.86	6.36 units on a scale Interval 5.95 to 6.78	6.43 units on a scale Interval 6.09 to 6.78	6.29 units on a scale Interval 5.71 to 6.88

SECONDARY outcome

Timeframe: 6 to 24 months post child birth (extended due to COVID-19)

Child mental development was measured by Bayley Mental Developmental Scale IV and the provision of psychosocial stimulation by the mother (study participant) as measured by the Home Observation Measurement Evaluation. The Bayley Mental Developmental Scale IV was used to measure cognitive development and expressive and receptive language in participants' children. The composite scores are scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scaled scores are associated with higher mental health development in children. The minimum and maximum values for the Home Observation Measurement Evaluation scale scores are 0 and 45 respectively. Higher scores are associated with a more enriched environment.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Telemedicine Non-Specialist

Serious events: 10 serious events

Other events: 1 other events

Deaths: 1 deaths

Arm 2: In-Person Non-Specialist

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3: Telemedicine Specialist

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 4: In-Person Specialist (4)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Telemedicine Non-Specialist n=472 participants at risk The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider.	Arm 2: In-Person Non-Specialist n=145 participants at risk The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider.	Arm 3: Telemedicine Specialist n=469 participants at risk The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider.	Arm 4: In-Person Specialist (4) n=144 participants at risk The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider.
General disorders Fetal or infant death	1.1% 5/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.21% 1/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
General disorders Hospitalization	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.69% 1/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.64% 3/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
General disorders Life threatening events in the mother, fetus, neonate or infant	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
General disorders Maternal death	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
General disorders Other serious important medical events	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.21% 1/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
General disorders Hospitalization + Life threatening events in the mother, fetus, neonate or infant	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.69% 1/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.21% 1/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.

Other adverse events

Other adverse events
Measure	Arm 1: Telemedicine Non-Specialist n=472 participants at risk The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider.	Arm 2: In-Person Non-Specialist n=145 participants at risk The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider.	Arm 3: Telemedicine Specialist n=469 participants at risk The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider.	Arm 4: In-Person Specialist (4) n=144 participants at risk The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider.
Psychiatric disorders Imminent and active suicidal intent	0.00% 0/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.69% 1/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.
Psychiatric disorders Increase in depressive symptoms	0.21% 1/472 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/145 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/469 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.	0.00% 0/144 • Baseline to 3-months post-randomization We reported all Serious Adverse Events (SAEs) to the Data Safety Monitoring Board (DSMB) within 72 hours of a confirmed SAE. We reported all Adverse Events (AEs) to the DSMB within 5 days of a confirmed AE as per the study's safety protocols and DSMB charter.

Additional Information

Dr. Daisy R Singla

Sinai Health System (Canada)

Phone: 416-535-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place