1230 Participants Needed

Brief Behavioral Activation Treatment for Postpartum Depression

(SUMMIT Trial)

Recruiting at 4 trial locations
DR
Overseen ByDaisy R Singla, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mount Sinai Hospital, Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

DR

Daisy R Singla, PhD

Principal Investigator

Sinai Health System

Are You a Good Fit for This Trial?

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

EPDS≥10
I am currently pregnant (up to 36 weeks) or recently had a baby (4-30 weeks ago).

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.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief, manualized behavioral activation treatment delivered either in-person or via telemedicine by specialists or trained non-specialists

6 months

Follow-up

Participants are monitored for depressive and anxiety symptoms using standardized scales

12 months

Child Mental Health Development

Child mental development is assessed using the Bayley Mental Developmental Scale IV and Home Observation Measurement Evaluation

6 to 24 months post child birth

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: TelemedicineExperimental Treatment1 Intervention
Group II: Non-specialistExperimental Treatment1 Intervention
Group III: SpecialistActive Control1 Intervention
Group IV: In-PersonActive Control1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security