Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,230
- 试验地点
- 10
- 主要终点
- Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcome assessors are independent from type of treatment delivery and allocation status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Pregnant up to 36 weeks or 4-30 weeks postpartum
- •Speaks English or (US sites) Spanish
排除标准
- •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
结局指标
主要结局
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
时间窗: 3-months post-randomization
Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.
次要结局
- Child Mental Health Development(6 to 24 months post child birth (extended due to COVID-19))
- Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score(6- and 12-months post-randomization)
- Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score(3-months post-randomization)
- Child Mental Health Development(6 to 24 months post child birth (extended due to COVID-19))