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Completed

NCT Number: NCT04153864

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

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.

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Key information

Conditions

Perinatal Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sinai Health System, Toronto, Ontario, Canada

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About this study

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:

  • March 2020-July 2021: For the duration of the COVID-19 pandemic period participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
  • July 2021 to January 2022: Randomization of participants to all 4 arms resumed, using a raking approach (weight ratio of 3:1 favoring In-Person to Telemedicine), to rebalance the arms.
  • January 2022 to April 2022: In light of the COVID-19 Omicron variant, participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
  • April 2022 to present: Randomization of participants to all 4 arms resumed at all sites (ratio 1:1:1:1) to 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. Randomization to all 4 arms will be followed until in-person arms are fully enrolled after which randomization 1:1 to the two telemedicine arms will be followed. A flexible study design was established at each site based on site-specific COVID restrictions.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Activation Treatment

Behavioral

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

Other names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

Primary outcomes

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

    Time frame: 3-months post-randomization

    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.

Secondary outcomes

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

    Time frame: 6- and 12-months post-randomization

    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.

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

    Time frame: 3-months post-randomization

    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. Child Mental Health Development

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

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

Registry information

Official study title

Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety

Acronym: SUMMIT

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Nov 6, 2019
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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