Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
Key facts
- Who runs it
- Mount Sinai Hospital, Canada
- Where
- Chapel Hill and Evanston, United StatesSee the 2 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Completed
- People taking part
- 1,230 people enrolled
- Started
- 6 Jan 2020
- Ended
- 13 Feb 2025
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Brief Behavioral Activation Treatment
- Record updated
- 14 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- EPDS≥10
- ≥18 years
- Pregnant up to 36 weeks or 4-30 weeks postpartum
- Speaks English or (US sites) Spanish
Who cannot take part
- Psychotropic medication dose or medication change within two weeks of enrollment or beginning treatment
- Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
- 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
Where in United States
Also in 1 other country, 3 sites
- University of North CarolinaChapel Hill, United States
- Northshore University Health SystemEvanston, United States
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Non-specialistTreatment being tested
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
Treatment: Brief Behavioral Activation Treatment
- SpecialistExisting treatment, for comparison
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
Treatment: Brief Behavioral Activation Treatment
- TelemedicineTreatment being tested
A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore
Treatment: Brief Behavioral Activation Treatment
- In-PersonExisting treatment, for comparison
A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore
Treatment: Brief Behavioral Activation Treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
- Record updated
- 14 August 2025