Clinical trial NCT04153864: Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
Official title: Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: Depression
Anxiety
Maternal mental health
Behavioral Activation
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Endeavor Health
name: Women's College Hospital
name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
name: University of Colorado, Boulder
name: Harvard Medical School (HMS and HSDM)
name: Patient-Centered Outcomes Research Institute
First posted: 2019-11-06
Enrollment: 1230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score
timeFrame: 3-months post-randomization
Secondary outcomes:
measure: Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) mean score
timeFrame: 6- and 12-months post-randomization
measure: Anxiety symptoms: Generalized Anxiety Disorder Scale (GAD-7) mean score
timeFrame: 3-, 6-, 12-months post-randomization
measure: Child Mental Health Development
timeFrame: 6 to 24 months post child birth (extended due to COVID-19)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Sinai Health System
name: Daisy R Singla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315.
citation: Bayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006.
citation: 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.
citation: 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.
citation: 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.