in progress

Final Research Plan

Perinatal Depression: Preventive Interventions

June 01, 2023

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Figure 1 is the analytic framework that depicts the two Key Questions to be addressed in the systematic review. The figure illustrates how interventions to prevent perinatal depression in pregnant or postpartum individuals may result in improved maternal, infant, and child health outcomes (KQ1). Additionally, the figure depicts whether interventions to prevent perinatal depression in pregnant or postpartum individuals are associated with any harms (KQ2).

  1. Do interventions to prevent perinatal depression improve health outcomes in pregnant or postpartum individuals or their children?
    1. In trials that limit enrollment to individuals at increased risk, how are participants identified as being at increased risk of developing perinatal depression?
  2. What harms are associated with interventions to prevent perinatal depression in pregnant or postpartum individuals?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework. 

  1. Are there reliable and valid prognostic tools for identifying individuals who are at increased risk of developing perinatal depression?
  2. When is the most effective time to provide interventions to prevent perinatal depression?

To the extent possible, we plan to describe the population, risk assessment, and intervention characteristics of the included studies. Data on population characteristics will help us to explore the degree to which the findings are representative of different populations of persons at risk for perinatal depression. These groups include, but are not limited to, categorizations by various social determinants of health, such as education, socioeconomic status, age, gender, and racial, ethnic, and cultural identity. We will endeavor to determine if depression prevention interventions developed and customized for specific populations are effective in those populations.

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

Category Included Excluded
Aim/ Objective Studies with a primary aim to prevent perinatal depression Studies restricted to screening for and treatment of depression during pregnancy or in the postpartum period
Population Pregnant and postpartum (≤1 year) individuals; study may target individuals with mental health symptoms or disorders (see exceptions under exclusion criteria)
  • Studies limited to perinatal individuals currently experiencing or being treated for a depressive episode
  • Studies limited to individuals with psychotic or development disorders (e.g., schizophrenia or pervasive development disorder) 
  • Studies limited to individuals with a medical condition (e.g., HIV/AIDS)
  • Studies limited to spouses or domestic partners
  • Studies limited to individuals in institutions (e.g., psychiatric inpatients, prison inmates, juvenile detention centers, foster homes, or group homes)
  • Studies limited to persons in long-term care or residential facilities
Studies in mixed populations that include >50% of any of the above populations will be excluded
Interventions Interventions to reduce the risk of perinatal depression initiated during pregnancy or the first year postpartum, including:
  • Behavioral counseling, educational, or supportive interventions
  • Physical activity
  • Prophylactic psychotropic pharmacotherapy
  • Infant/parent sleep promotion 
  • Complementary therapies (e.g., yoga or light therapy)
  • Interventions within closed preexisting social networks (e.g., church or worksite)
  • General parenting education without a mental health component (e.g., prenatal or infant care classes) 
  • Dietary supplements
  • Hormonal therapies
  • Care delivery model interventions
Comparators
  • No intervention
  • Usual care
  • Waitlist
  • Attention control
  • Minimal intervention (e.g., usual care limited to no more than 15 minutes of information)
  • Placebo required for medication trials
  
Outcomes KQ 1:

Maternal health outcomes:

  • Depression incidence or symptoms (required)
  • Suicide deaths, attempts, or ideation, including self-harm
  • Anxiety incidence or symptoms
  • Health-related quality of life
  • Functioning, including maternal functioning
  • ED visits and hospital admission admissions, including psychiatric hospital admissions
  • Marital discord and family function
Infant/child health outcomes (for newborn infant or other children in the family):
  • Mortality
  • Neglect or abuse
  • Physical, social, emotional, or behavioral development 
  • Attachment or bonding
  • Achievement of recognized developmental milestones 
  • Health care utilization (e.g., ED visits, hospital admissions, or neonatal intensive care unit stays/number of days)
KQ 2:
  • Serious maternal or fetal/infant harms related to antidepressant use
  • Neonatal intensive care unit admission
  • Serious harms reported in trials of treatment benefit 
  • Withdrawals due to adverse events in trials of treatment benefit
 KQ 1: Maternal behavioral intermediate outcomes (e.g., physical activity levels or dietary intake)
Timing of Outcome Assessment KQ 1: ≥6 weeks after baseline assessment or intervention initiation

KQ 2: ≥6 weeks after baseline assessment or intervention initiation

For prophylactic psychotropic pharmacotherapy interventions only: any time after the intervention is initiated

 KQ 1: <6 weeks after baseline assessment or intervention initiation
Settings
  • Primary care settings
  • Virtual (e.g., web-based interventions) 
  • Mental health clinic settings
  • Community settings
  • Home visits
  • Correctional facilities
  • School classrooms
  • Worksites
  • Inpatient/residential/long-term care facilities
  • EDs
Study Designs KQ 1: RCTs

KQ 2: RCTs; for medications determined to be efficacious in KQ1 evidence: RCTs, existing systematic reviews

 All other study designs (e.g., case report or case series)
Countries Countries categorized as “Very High” on the 2021 Human Development Index, as defined by the United Nations Development Programme Countries not categorized as “Very High” on the Human Development Index
Languages English Languages other than English
Quality  Fair or good, according to design-specific criteria Poor, according to design-specific criteria

Abbreviations: AIDS = acquired immunodeficiency syndrome; ED = emergency department; HIV = human immunodeficiency virus; KQ = key question; RCT = randomized, controlled trial.

The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) website from February 23, 2023, to March, 22, 2023. In response to public comment, the Research Plan was revised to clarify the list of included and excluded maternal health outcomes for Key Question 1 (benefits) and the included study designs and minimum followup time requirement for Key Question 2 (harms). Other minor clarifying revisions were made to the Research Plan text.