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

Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: Brief Behavioral Activation Treatment

Detailed Description

Eligible participants are 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. However, due to the COVID-19 pandemic, recruitment was adjusted as below:

1. March 2020-July 2021: For the duration of the COVID-19 pandemic period participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
2. July 2021 to January 2022: Randomization of participants to all 4 arms resumed, using a raking approach (weight ratio of 3:1 favoring In-Person to Telemedicine), to rebalance the arms.
3. January 2022 to April 2022: In light of the COVID-19 Omicron variant, participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
4. April 2022 to present: Randomization of participants to all 4 arms resumed at all sites (ratio 1:1:1:1) to 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. Randomization to all 4 arms will be followed until in-person arms are fully enrolled after which randomization 1:1 to the two telemedicine arms will be followed. A flexible study design was established at each site based on site-specific COVID restrictions.

This approach was verified by the study statistician, an independent methodologist and the study funder. All analyses will be run as both intent-to-treat and per protocol.

• Study Type: Interventional
• Enrollment (Actual): 1230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daisy R Singla, PhD; Phone Number: 416 562 4438; Email: daisy.singla@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Sinai Health System
• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• EPDS≥10
• ≥18 years
• Pregnant up to 36 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms
Experimental: Non-specialist; 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	Behavioral: Brief Behavioral Activation Treatment; A manualized 6-8 session BA treatment delivered individually to each participant.; Other Names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms
Experimental: Telemedicine; A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore	Behavioral: Brief Behavioral Activation Treatment; A manualized 6-8 session BA treatment delivered individually to each participant.; Other Names: 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	Behavioral: Brief Behavioral Activation Treatment; A manualized 6-8 session BA treatment delivered individually to each participant.; Other Names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score	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. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth, obstetrical complications and COVID-19 related events).	3-months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score	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. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth, obstetrical complications and COVID-19 related events).	6- and 12-months post-randomization
Anxiety symptoms: Generalized Anxiety Disorder Scale (GAD-7) mean score	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. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth, obstetrical complications and COVID-19 related events).	3-, 6-, 12-months post-randomization
Child Mental Health Development	Child mental development is measured by Bayley Mental Developmental Scale IV and the provision of psychosocial stimulation by the mother measured by Home Observation Measurement Evaluation. Cognitive development, expressive and receptive language scores are measured by Bayley Mental Developmental Scale IV. 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.	6 to 24 months post child birth (extended due to COVID-19)

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Harvard Medical School (HMS and HSDM); Patient-Centered Outcomes Research Institute; Sunnybrook Health Sciences Centre; Unity Health Toronto; University of North Carolina, Chapel Hill; University of Colorado, Boulder; Women's College Hospital; NorthShore University HealthSystem
• Investigators: Principal Investigator: Daisy R Singla, PhD, Sinai Health System

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
• Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315.
• Bayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006.
• Singla DR, Meltzer-Brody SE, Silver RK, Vigod SN, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Schoueri-Mychasiw N, Hollon SD, Kiss A, Clark D, Dalfen AK, Dimidjian S, Gaynes BN, Katz SR, Lawson A, Leszcz M, Maunder RG, Mulsant BH, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Dennis CL, Patel V. Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial. Trials. 2021 Mar 5;22(1):186. doi: 10.1186/s13063-021-05075-1.
• McCabe-Beane JE, Segre LS, Perkhounkova Y, Stuart S, O'Hara MW. The identification of severity ranges for the Edinburgh Postnatal Depression Scale. Journal of Reproductive and Infant Psychology. 2016;34(3):293-303.
• Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Estimated): April 10, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Behavioral Activation; Anxiety; Maternal mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Infant, Newborn, Diseases; Depression; Depressive Disorder; Asphyxia Neonatorum
• Other Study ID Numbers: PCS-2018C1-10621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No