Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)

NCT04153864 | Completed Results DMC

• 1 other identifier: PCS-2018C1-10621
• Study Type: interventional
• Target: 1,230
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Perinatal Depression

Keywords

Depression; Anxiety; Maternal mental health; Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score

  6- and 12-months post-randomization

• Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score

  3-months post-randomization

• Child Mental Health Development

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

Study Arms (4)

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

Behavioral: Brief 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

Behavioral: Brief 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

Behavioral: Brief Behavioral Activation Treatment

In-Person

ACTIVE COMPARATOR

A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore

Behavioral: Brief Behavioral Activation Treatment

Interventions

Brief Behavioral Activation Treatment BEHAVIORAL

A manualized 6-8 session BA treatment delivered individually to each participant.

Also known as: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

In-Person; Non-specialist; Specialist; Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EPDS≥10
• ≥18 years
• Pregnant up to 36 weeks or 4-30 weeks postpartum
• Speaks English or (US sites) Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• University of North Carolina, Chapel Hill: collaborator
• Endeavor Health: collaborator
• Women's College Hospital: collaborator
• Unity Health Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• University of Colorado, Boulder: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (12)

• 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.

  PMID: 3651732 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.

  PMID: 16717171 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.

  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.

  PMID: 25161068 BACKGROUND

• 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.

  PMID: 41028222 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.

  PMID: 40835941 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.

  PMID: 40833774 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.

  PMID: 40033113 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.

  PMID: 36174135 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.

  PMID: 33673867 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Dr. Daisy R Singla
• Organization: Sinai Health System (Canada)

daisy.singla@utoronto.ca

416-535-8501

Study Officials

• Daisy R Singla, PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors are independent from type of treatment delivery and allocation status.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention modules include: 1. Brief BA psychological treatment delivered by a non-specialist provider 2. Brief BA psychological treatment delivered through telemedicine

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: January 6, 2020
• Primary Completion: February 26, 2024
• Study Completion: February 13, 2025
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (3)