N/A
Completed N=1,230
Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
Source: ClinicalTrials.gov NCT04153864 ↗Enrolled (actual)
1,230
Serious AEs
1.5%
Results posted
Aug 2025
Primary outcomePrimary: Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score — 9.27; 8.91; 9.15; 8.92 score on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score |
— | — |
| SECONDARY Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score |
— | — |
| SECONDARY Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score |
6.44; 6.36; 6.43; 6.29 | <0.05 sig |
| SECONDARY Child Mental Health Development |
— | — |
Eligibility Criteria
Inclusion Criteria
- EPDS≥10
- ≥18 years
- Pregnant up to 36 weeks or 4-30 weeks postpartum
- Speaks English or (US sites) Spanish
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04153864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.