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Behavioral Intervention

Brief Behavioral Activation Treatment for Postpartum Depression (SUMMIT Trial)

N/A
Waitlist Available
Led By Daisy R Singla, PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years
Be older than 18 years old
Must not have
Non-English, non-Spanish speakers
Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 to 24 months post child birth (extended due to covid-19)
Awards & highlights
No Placebo-Only Group

Summary

This trial is examining whether a brief behavioral activation treatment delivered via telemedicine is as effective as the same treatment delivered in person, and whether the treatment delivered by non-mental health nurses is as effective as when delivered by specialist providers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Behavioral Activation Treatment generally has minimal side effects as it's a psychological therapy rather than a drug-based intervention. However, discussing emotional topics can sometimes cause temporary discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English or Spanish.
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I do not have active suicidal thoughts or untreated psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 to 24 months post child birth (extended due to covid-19)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 24 months post child birth (extended due to covid-19) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Anxiety symptoms: Generalized Anxiety Disorder Scale (GAD-7) mean score
Child Mental Health Development
Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TelemedicineExperimental Treatment1 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-specialistExperimental Treatment1 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: SpecialistActive Control1 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-PersonActive Control1 Intervention
A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,569 Previous Clinical Trials
4,318,477 Total Patients Enrolled
5 Trials studying Postpartum Depression
255 Patients Enrolled for Postpartum Depression
Sunnybrook Health Sciences CentreOTHER
681 Previous Clinical Trials
1,564,528 Total Patients Enrolled
1 Trials studying Postpartum Depression
156 Patients Enrolled for Postpartum Depression
Harvard Medical School (HMS and HSDM)OTHER
204 Previous Clinical Trials
1,315,455 Total Patients Enrolled
Mount Sinai Hospital, CanadaLead Sponsor
204 Previous Clinical Trials
67,967 Total Patients Enrolled
Women's College HospitalOTHER
106 Previous Clinical Trials
42,331 Total Patients Enrolled
2 Trials studying Postpartum Depression
286 Patients Enrolled for Postpartum Depression
Unity Health TorontoOTHER
562 Previous Clinical Trials
452,721 Total Patients Enrolled
1 Trials studying Postpartum Depression
103 Patients Enrolled for Postpartum Depression
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,029 Total Patients Enrolled
1 Trials studying Postpartum Depression
9,444 Patients Enrolled for Postpartum Depression
NorthShore University HealthSystemOTHER
132 Previous Clinical Trials
736,412 Total Patients Enrolled
University of Colorado, BoulderOTHER
124 Previous Clinical Trials
28,191 Total Patients Enrolled
3 Trials studying Postpartum Depression
197 Patients Enrolled for Postpartum Depression
Daisy R Singla, PhDPrincipal InvestigatorSinai Health System

Media Library

Brief Behavioral Activation Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04153864 — N/A
Postpartum Depression Research Study Groups: Specialist, Telemedicine, Non-specialist, In-Person
Postpartum Depression Clinical Trial 2023: Brief Behavioral Activation Treatment Highlights & Side Effects. Trial Name: NCT04153864 — N/A
Brief Behavioral Activation Treatment (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04153864 — N/A
~208 spots leftby Dec 2025
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