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

Perinatal Depression Clinical Trial

— SUMMIT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04153864
• Other study ID #: PCS-2018C1-10621
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1230
• Est. completion date: March 1, 2025
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Perinatal Depression

Intervention

Behavioral:
• Brief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.

Locations

Country	Name	City	State
Canada	Sinai Health System	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
United States	University of North Carolina	Chapel Hill	North Carolina
United States	NorthShore University Health System	Evanston	Illinois

Sponsors (9)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Harvard Medical School (HMS and HSDM), NorthShore University HealthSystem, Patient-Centered Outcomes Research Institute, Sunnybrook Health Sciences Centre, Unity Health Toronto, University of Colorado, Boulder, University of North Carolina, Chapel Hill, Women's College Hospital

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

Bayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006.

Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315.

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. — View 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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)