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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to 24 months post child birth (extended due to covid-19)

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.

Primary study objectives

Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score

Secondary study objectives

Anxiety symptoms: Generalized Anxiety Disorder Scale (GAD-7) mean score

Child Mental Health Development

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

0 / 3Eligibility criteria met