Brief Behavioral Activation Treatment for Postpartum Depression

(SUMMIT Trial)

Recruiting at 4 trial locations

Overseen By Daisy R Singla, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Must not be taking: Psychotropics

Disqualifiers: Suicidal intent, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1230 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Daisy R Singla, PhD

Principal Investigator

Sinai Health System

Eligibility Criteria

The SUMMIT trial is for pregnant women up to 36 weeks or those who are 4-30 weeks postpartum, experiencing depression with an EPDS score of at least 10. Participants must be over 18 and speak English or Spanish. It excludes those with severe fetal issues, recent infant death, active suicidal thoughts, psychosis, recent psychotropic medication changes, ongoing psychotherapy, substance abuse issues, or non-English/Spanish speakers.

Inclusion Criteria

I speak English or Spanish.

EPDS≥10

I am 18 years old or older.

Exclusion Criteria

I do not speak English or Spanish.

You are currently addicted to drugs or alcohol.

My psychotropic medication dose hasn't changed in the last two weeks.

Treatment Details

Interventions

• Brief Behavioral Activation Treatment

Trial Overview SUMMIT is testing the effectiveness of a brief Behavioral Activation Treatment for perinatal depression and anxiety delivered via telemedicine versus in-person. It also compares treatment by trained nurses to specialist providers like psychiatrists. The study aims to understand how well these methods work across different locations and patient groups.

Participant Groups

Group I: Telemedicine Experimental Treatment 1 Intervention

A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore

Group II: Non-specialist Experimental Treatment 1 Intervention

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

Group III: Specialist Active Control 1 Intervention

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

Group IV: In-Person Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials

208

Recruited

1,421,000+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

NorthShore University HealthSystem

Collaborator

Trials

134

Recruited

740,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+