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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Endeavor Health | OTHER |
| Women's College Hospital | OTHER |
| Unity Health Toronto |
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SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
Eligible participants are 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. However, due to the COVID-19 pandemic, recruitment was adjusted as below:
This approach was verified by the study statistician, an independent methodologist and the study funder. All analyses will be run as both intent-to-treat and per protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-specialist | Experimental | Trained non-mental health providers (e.g., nurses or midwives) with general healthcare professional skills (as assessed during recruitment) with no previous experience delivering psychological treatments implementing a brief, manualized behavioral activation treatment |
|
| Specialist | Active Comparator | Psychiatrists, psychologists and social workers with experience in treating perinatal mental illness and a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment |
|
| Telemedicine | Experimental | A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore |
|
| In-Person | Active Comparator | A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Activation Treatment | Behavioral | A manualized 6-8 session BA treatment delivered individually to each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 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. | 3-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 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. | 6- and 12-months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daisy R Singla, PhD | Sinai Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | 60201 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3651732 | Background | Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782. | |
| 16717171 | Background | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Telemedicine Non-Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider. |
| FG001 | Arm 2: In-Person Non-Specialist | The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider |
| FG002 | Arm 3: Telemedicine Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider. |
| FG003 | Arm 4: In-Person Specialist | The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Telemedicine Non-Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider. |
| BG001 | Arm 2: In-Person Non-Specialist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data is missing for 4 participants, distributed as follows: Arm 1 = 1 Arm 3 = 3 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3-months post-randomization |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Telemedicine Non-Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal or infant death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Imminent and active suicidal intent | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daisy R Singla | Sinai Health System (Canada) | 416-535-8501 | 39423 | daisy.singla@utoronto.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2024 | Jul 25, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2023 | Jun 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| University of Colorado, Boulder | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
The intervention modules include:
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Investigators and outcome assessors are independent from type of treatment delivery and allocation status.
|
| Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 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. | 3-months post-randomization |
| Child Mental Health Development | 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. | 6 to 24 months post child birth (extended due to COVID-19) |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Sinai Health System | Toronto | Ontario | M5G 1X5 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Background | Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315. |
| Background | Bayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006. |
| Background | 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. |
| 25161068 | Background | Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806. |
| 41028222 | Derived | Andrejek N, Lea Z, Cussons A, Sandeep S, Dennis CL, La Porte LM, Vigod SN, Silver RK, Meltzer-Brody S, Singla DR. Advancing telemedicine and task-sharing to improve access to psychotherapy for perinatal populations. Commun Med (Lond). 2025 Sep 30;5(1):406. doi: 10.1038/s43856-025-01099-9. |
| 40835941 | Derived | Zaidan M, Lawson AS, Andrejek N, Walsh K, Dennis CL, Meltzer-Brody S, Silver RK, Stuebe AM, Vigod SN, Singla DR. Bridges to treatment satisfaction: the roles of trauma, social support, race and ethnicity among perinatal women receiving behavioural activation therapy. BMC Med. 2025 Aug 20;23(1):489. doi: 10.1186/s12916-025-04272-y. |
| 40833774 | Derived | Kaliush PR, Molina NC, Berenbaum TS, Dennis CL, Gaynes BN, Meltzer-Brody S, Reyes-Rodriguez ML, Silver RK, Stuebe AM, Vigod SN, Schiller CE, Singla DR. Behavioral Activation for Perinatal Suicide Ideation: Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1234-1239. doi: 10.1001/jamapsychiatry.2025.2116. |
| 40459806 | Derived | Andrejek N, Ravitz P, Mikelsteins K, La Porte L, Kim JJ, Schiller CE, Reyes-Rodriguez ML, Barker LC, Dennis CL, Silver RK, Meltzer-Brody S, Singla DR. Clinical Supervision Models for Non-specialist Providers Delivering Psychotherapy: A Qualitative Analysis. Adm Policy Ment Health. 2025 Sep;52(5):932-949. doi: 10.1007/s10488-025-01450-1. Epub 2025 Jun 3. |
| 40033113 | Derived | Singla DR, Silver RK, Vigod SN, Schoueri-Mychasiw N, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Lawson AS, Kiss A, Hollon SD, Dennis CL, Berenbaum TS, Krohn HA, Gibori JE, Charlebois J, Clark DM, Dalfen AK, Davis W, Gaynes BN, Leszcz M, Katz SR, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Zlobin C, Mulsant BH, Patel V, Meltzer-Brody S. Task-sharing and telemedicine delivery of psychotherapy to treat perinatal depression: a pragmatic, noninferiority randomized trial. Nat Med. 2025 Apr;31(4):1214-1224. doi: 10.1038/s41591-024-03482-w. Epub 2025 Mar 3. |
| 36174135 | Derived | Singla DR, Hossain S, Andrejek N, Cohen MJ, Dennis CL, Kim J, La Porte L, Meltzer-Brody SE, Puerto Nino A, Ravitz P, Schoueri-Mychasiw N, Silver R, Vigod SN, Zibaman M, Schiller CE. Culturally sensitive psychotherapy for perinatal women: A mixed methods study. J Consult Clin Psychol. 2022 Oct;90(10):770-786. doi: 10.1037/ccp0000754. Epub 2022 Sep 29. |
| 33673867 | Derived | Singla DR, Meltzer-Brody SE, Silver RK, Vigod SN, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Schoueri-Mychasiw N, Hollon SD, Kiss A, Clark D, Dalfen AK, Dimidjian S, Gaynes BN, Katz SR, Lawson A, Leszcz M, Maunder RG, Mulsant BH, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Dennis CL, Patel V. Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial. Trials. 2021 Mar 5;22(1):186. doi: 10.1186/s13063-021-05075-1. |
| Lost to Follow-up |
|
| Did not complete 3-month follow-up assessment but continued in the trial |
|
The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider
| BG002 | Arm 3: Telemedicine Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider. |
| BG003 | Arm 4: In-Person Specialist | The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline EPDS | 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. | Mean | Standard Deviation | units on a scale |
|
| Baseline GAD-7 | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Specialist | Psychiatrists, psychologists and social workers with a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment |
| OG002 | Telemedicine | 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) |
| OG003 | In-Person | A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within Toronto, Chapel Hill and Chicago |
|
|
|
| Secondary | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 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. | Not Posted | 6- and 12-months post-randomization | Participants |
| Secondary | Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 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. |
| Posted | Mean | 95% Confidence Interval | units on a scale | 3-months post-randomization |
|
|
|
|
| Secondary | Child Mental Health Development | 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. | Not Posted | 6 to 24 months post child birth (extended due to COVID-19) | Participants |
| 1 |
| 472 |
| 10 |
| 472 |
| 1 |
| 472 |
| EG001 | Arm 2: In-Person Non-Specialist | The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider. | 0 | 145 | 2 | 145 | 0 | 145 |
| EG002 | Arm 3: Telemedicine Specialist | The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider. | 0 | 469 | 6 | 469 | 0 | 469 |
| EG003 | Arm 4: In-Person Specialist (4) | The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider. | 0 | 144 | 0 | 144 | 1 | 144 |
| Hospitalization | General disorders | Non-systematic Assessment |
|
| Life threatening events in the mother, fetus, neonate or infant | General disorders | Non-systematic Assessment |
|
| Maternal death | General disorders | Non-systematic Assessment |
|
| Other serious important medical events | General disorders | Non-systematic Assessment |
|
| Hospitalization + Life threatening events in the mother, fetus, neonate or infant | General disorders | Non-systematic Assessment |
|
| Increase in depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
|
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| Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis. | t-test, 1 sided | <0.05 | Mean Difference (Final Values) | 0.14 | 1-Sided | 95 | 0.73 | Non-Inferiority | The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions. |