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

Study Overview
=================
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: 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. 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. 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. 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.

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

Conditions
-----------------
Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: Brief Behavioral Activation Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The intervention modules include: Brief BA psychological treatment delivered by a non-specialist provider Brief BA psychological treatment delivered through telemedicine
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-specialist<br>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<br>* A manualized 6-8 session BA treatment delivered individually to each participant.<br>* Other names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms;|
| Active Comparator: Specialist<br>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<br>* A manualized 6-8 session BA treatment delivered individually to each participant.<br>* Other names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms;|
| Experimental: Telemedicine<br>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<br>* A manualized 6-8 session BA treatment delivered individually to each participant.<br>* Other names: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms;|
| Active Comparator: In-Person<br>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<br>* A manualized 6-8 session BA treatment delivered individually to each participant.<br>* 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Anxiety, Maternal mental health, Behavioral Activation