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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SUMMIT Trial 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.Check my eligibility

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.See study design

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.

SUMMIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

SUMMIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

Child Mental Health Development

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

SUMMIT 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,510 Previous Clinical Trials

4,191,863 Total Patients Enrolled

6 Trials studying Postpartum Depression

340 Patients Enrolled for Postpartum Depression

Sunnybrook Health Sciences CentreOTHER

657 Previous Clinical Trials

1,550,081 Total Patients Enrolled

1 Trials studying Postpartum Depression

156 Patients Enrolled for Postpartum Depression

Harvard Medical School (HMS and HSDM)OTHER

195 Previous Clinical Trials

1,314,815 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes is this trial hoping to realize?

"The primary goal of this trial, as assessed over a 3-month post-randomization period, is to treat depressive symptoms in expectant mothers through telemedicine. As secondary objectives, the treatment of anxiety will be evaluated using the Generalized Anxiety 7 Item Questionnaire (range 0 to 21), and Response/Remission measured via Patient Health Questionnaire 9 (range 0 to 27). Additionally, Child Mental health Development will rely on Bayley Mental Developmental Scale III scores (mean 100; standard deviation 15; range 40–160) and Home Observation Measurement Evaluation scale scores (0–45); higher values indicating better outcomes"

Answered by AI

Are there any vacancies in this clinical experiment for participants?

"Per the details presented on clinicaltrials.gov, this particular trial is currently seeking participants for its research. This investigation was initially posted on June 1st 2020 and has since been amended as of October 2021."

Answered by AI

What is the size of the sample group participating in this research endeavor?

"Yes, clinicaltrials.gov confirms that this medical trial is presently recruiting patients. It initially went live on June 1st 2020 and was last updated on October 1st 2021; 1368 individuals are needed for the study at 5 different sites."

Answered by AI