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

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Active, not recruiting

Conditions

Perinatal Depression

Treatments

Behavioral: Brief Behavioral Activation Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04153864
PCS-2018C1-10621

Details and patient eligibility

About

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.

Full description

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Enrollment

1,230 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

1,230 participants in 4 patient groups

Non-specialist
Experimental group
Description:
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:
Behavioral: Brief Behavioral Activation Treatment
Specialist
Active Comparator group
Description:
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:
Behavioral: Brief Behavioral Activation Treatment
Telemedicine
Experimental group
Description:
A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore
Treatment:
Behavioral: Brief Behavioral Activation Treatment
In-Person
Active Comparator group
Description:
A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore
Treatment:
Behavioral: Brief Behavioral Activation Treatment

Trial documents
1

Trial contacts and locations

5

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Central trial contact

Daisy R Singla, PhD

Data sourced from clinicaltrials.gov

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