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Scaling Up Maternal Mental Health Care by Increasing Access to Treatment (SUMMIT) (SUMMIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153864
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
NorthShore University HealthSystem
Women's College Hospital
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
University of Colorado, Boulder
Harvard Medical School
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Brief Summary:
SUMMIT (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=1368). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether one brief, behavioral activation (BA) delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health 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, 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.

Condition or disease Intervention/treatment Phase
Perinatal Depression Behavioral: Brief Behavioral Activation Treatment Not Applicable

Detailed Description:
Eligible participants will be randomly assigned to the same BA treatment for perinatal depressive and anxiety symptoms in one of four arms: 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1368 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

The intervention modules include:

  1. Brief BA psychological treatment delivered by a non-specialist provider
  2. Brief BA psychological treatment delivered through telemedicine
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigators and outcome Assessors are independent from type of treatment delivery and allocation status.
Primary Purpose: Treatment
Official Title: Scaling Up Maternal Mental Health Care by Increasing Access to Treatment (SUMMIT): A Study Protocol for Perinatal Depression and Anxiety
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-specialist
Trained nurses or midwives with general health care professional skills (as assessed during recruitment) with no previous experience delivering psychological treatments implementing a brief, manualized behavioral activation treatment
Behavioral: Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Other Name: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

Active Comparator: Specialist
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
Behavioral: Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Other Name: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

Experimental: Telemedicine
A brief, manualized behavioral activation treatment delivered over Ontario telemedicine Network in Toronto, via the UNC TelePsychiatry Program in Chapel Hill, and via Zoom in Chicago
Behavioral: Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Other Name: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

Active Comparator: In-Person
A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore Chicago
Behavioral: Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Other Name: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms




Primary Outcome Measures :
  1. Treatment of perinatal depressive symptoms by non-specialist providers [ Time Frame: 3-months post-randomization ]
    Brief BA psychological treatment is delivered by non-specialist providers. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms.

  2. Treatment of perinatal depressive symptoms through telemedicine [ Time Frame: 3-months post-randomization ]
    Brief BA psychological treatment is delivered through telemedicine. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms.


Secondary Outcome Measures :
  1. Treatment of perinatal anxiety symptoms by non-specialist providers [ Time Frame: 3 months post-randomization ]
    Brief BA psychological treatment is delivered by non-specialist providers. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms.

  2. Treatment of perinatal anxiety symptoms through telemedicine [ Time Frame: 3 months post-randomization ]
    Brief BA psychological treatment is delivered through telemedicine. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms.

  3. Child Mental Health Development [ Time Frame: 9 to 12 months post child birth ]
    Child mental development is measured by Bayley Mental Developmental Scale III and the provision of psychosocial stimulation by the mother measured by Home Observation Measurement Evaluation. Cognitive development, expressive and receptive language, and fine and gross motor development composite scores are measured by Bayley Mental Developmental Scale III. The composite scores are scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scaled scores are associated with higher mental health development in child. The minimum and maximum values for the Home Observation Measurement Evaluation scale scores are 0 and 45 respectively. Higher scores are associated with more enriched environment.

  4. Response and Remission [ Time Frame: 3 months post-randomization ]
    Response and Remission is measured by Patient Health Questionnaire 9. The minimum and maximum values for Patient Health Questionnaire 9 are 0 and 27 respectively. Response and Remission is defined as PHQ-9 of less than 10 and 5 respectively.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EPDS≥10
  • ≥18 years
  • Pregnant up to 30 weeks or 4-30 weeks postpartum
  • Speaks English or (US sites) Spanish

Exclusion Criteria:

  • Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
  • Psychotropic medication dose or medication change within two weeks of enrollment or beginning treatment
  • Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
  • Active substance abuse or dependence
  • Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
  • Non-English, non-Spanish speakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153864


Contacts
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Contact: Daisy R Singla, PhD 416 562 4438 daisy.singla@utoronto.ca
Contact: Sarah Rachel Katz 4165864800 ext 4407 sarahrachel.katz@sinaihealthsystem.ca

Locations
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United States, Illinois
NorthShore University Health System
Evanston, Illinois, United States, 60201
Contact: Richard K Silver, MD       RSilver@northshore.org   
Contact: Christina Goode       CGoode@northshore.org   
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Contact: Samantha Meltzer-Brody, MD, MPH       samantha_meltzer-brody@med.unc.edu   
Contact: Holly Krohn       holly_krohn@med.unc.edu   
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Contact: Cindy-Lee Dennis       cindylee.dennis@utoronto.ca   
Sinai Health System
Toronto, Ontario, Canada, M5G 1X5
Contact: Daisy R Singla, PhD    416 562 4438    daisy.singla@utoronto.ca   
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Contact: Simone Vigod       simone.vigod@wchospital.ca   
Contact: Maria Michalowska       Maria.Michalowska@wchospital.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
University of North Carolina, Chapel Hill
NorthShore University HealthSystem
Women's College Hospital
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
University of Colorado, Boulder
Harvard Medical School
Investigators
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Principal Investigator: Daisy R Singla, PhD Sinai Health System

Publications:
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT04153864    
Other Study ID Numbers: PCS-2018C1-10621
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Sinai Hospital, Canada:
Depression
Anxiety
Maternal mental health
Behavioral Activation
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases