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Draft Research Plan

Draft Research Plan for Perinatal Depression: Interventions

This opportunity for public comment expired on June 15, 2016 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Abbreviations: HrQoL = health-related quality of life; PPD = postpartum depression.

Text Description.

This figure is the analytic framework that depicts the two Key Questions to be addressed in the systematic review. The figure illustrates how interventions to prevent postpartum depression may result in improved health outcomes for both the mother and infant/child, including decreased incidence of postpartum depression; improved quality of life; improved psychosocial development; and decreased mortality, neglect, and abuse (KQ 1). Additionally, the figure depicts whether interventions to prevent postpartum depression are associated with any harms (KQ 2).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Do interventions to prevent postpartum depression improve health outcomes among postpartum women and their infants?
    1. How are women identified as being at high risk of developing postpartum depression among trials that limit enrollment to high-risk women?
  2. What harms are associated with interventions to prevent postpartum depression among pregnant or postpartum women and their infants?

Draft: Proposed Contextual Questions

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 women who are at high risk of developing postpartum depression?
  2. When is the most effective time to intervene during pregnancy or the postpartum period to prevent postpartum depression?

Draft: Proposed Research Approach

The Proposed 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 (KQs).

  Included Excluded
Objective Studies on interventions to prevent postpartum depression Studies restricted to screening for and treatment of depression during pregnancy or in the postpartum period
Populations Pregnant women and new mothers (≤12 weeks postpartum) of any age; may target women with mental health symptoms or disorders (see exceptions under exclusion criteria)
  • Studies limited to postpartum women currently experiencing or being treated for a depressive episode
  • Studies limited to women with psychotic or development disorders (e.g., schizophrenia, pervasive development disorder)
  • Studies limited to women with a medical condition (e.g., HIV/AIDS)
  • Nonhuman populations
  • Studies limited to spouses or domestic partners
  • Studies limited to persons in institutions (e.g., psychiatric inpatients, prison inmates, juvenile detention centers, foster homes, group homes)
  • Studies limited to persons in long-term care or residential facilities

Studies with mixed populations but more than 50% of the above populations will be excluded

Interventions Interventions to reduce the risk of postpartum depression, including:
  • Counseling (e.g., psychoeducation, cognitive behavioral therapy, interpersonal psychotherapy, nondirective counseling, debriefing), psychoeducation, or other counseling or social support (including peer mentoring)
  • Prophylactic use of antidepressants (i.e., tricyclic antidepressants and monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, dopamine reuptake inhibitors, 5-HT2A receptor antagonists, serotonin reuptake inhibitors, tetracyclic antidepressants); harms will only be examined for medications with evidence of benefit to prevent postpartum depression
  • Widely available complementary and alternative therapies (i.e., massage, acupuncture, hypnosis, light exposure, yoga)
  • Hormonal therapy (e.g., estrogen, oxytocin, thyroxine)
  • Interventions within closed preexisting social networks (e.g., church, worksite program)
  • Healthy lifestyle counseling (e.g., physical activity, diet)
  • Parenting education (e.g., prenatal or infant care classes)
  • Other prophylactic medications


  • 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
Active intervention (i.e., comparative effectiveness)
Outcomes KQ 1: Maternal health outcomes
  • Depression incidence or symptoms (required outcome)
  • Suicide deaths, attempts, or ideation, including self-harm
  • Health-related quality of life, including stress and anxiety
  • Functioning
  • Health care utilization (e.g., emergency department visits, hospital admissions)
  • Breastfeeding
  • Marital discord and family function

Infant/child health outcomes

  • Mortality
  • Neglect or abuse
  • Physical, social, emotional, or behavioral development
  • Attachment or bonding
  • Achievement of recognized developmental milestones
  • Health care utilization (e.g., emergency department visits, hospital admissions)

KQ 2:

  • Satisfaction with care or care avoidance
  • Maternal or fetal/infant harms related to antidepressant use:
    • Serotonin syndrome or serotonin withdrawal syndrome
    • Cardiac effects
    • Seizures or convulsions
    • Gestational diabetes or metabolic effects
    • Preeclampsia
    • Vaginal bleeding or postpartum hemorrhage
    • Miscarriage or spontaneous abortion
    • Perinatal death
    • Preterm birth or early gestational age
    • Low birth weight or small for gestational age
    • Neonatal respiratory distress
    • Pulmonary hypertension
    • Major malformations, including cardiac malformations
    • Neonatal intensive care unit admission
    • Other harms reported in trials of treatment benefit
  • Other harms of psychotherapy
KQ 1: Maternal behavioral outcomes (e.g., increase in physical activity)
Timing of Outcome Assessment KQ 1: Postdelivery to 12 months postpartum

KQ 2: Any time after intervention, up to 12 months postpartum

KQ 1: During pregnancy and ≥12 months postpartum

KQ 2: ≥12 months postpartum

  • Primary care settings (e.g., internal medicine, family medicine, obstetrics/gynecology, pediatrics, family planning clinics, military health clinics, school-based health clinics, midwifery services)
  • 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
  • Emergency departments
Study designs KQ 1: Randomized, controlled trials; controlled clinical trials

KQ 2: Systematic reviews; meta-analyses; randomized, controlled trials; controlled clinical trials; and large comparative cohort studies (for harms of antidepressant use only)

All other study designs (e.g., case reports, case series)
Countries Countries categorized as “very high” on the 2014 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 USPSTF criteria Poor, according to design-specific USPSTF criteria
Current as of: May 2016

Internet Citation: Draft Research Plan: Perinatal Depression: Interventions. U.S. Preventive Services Task Force. May 2016.

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