Final Research Plan

Perinatal Depression: Preventive Interventions

August 11, 2016

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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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.

The draft Research Plan was available for comment from May 19 until June 16, 2016 at 5:00 p.m., ET.

Abbreviation: HrQoL = health-related quality of life.

Text Description.

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 may result in improved health outcomes for both the mother and infant/child, including decreased incidence of perinatal depression and symptoms; improved quality of life and functioning; improved health, physical, and psychosocial development; and decreased mortality, neglect, and abuse (KQ 1). Additionally, the figure depicts whether interventions to prevent perinatal depression are associated with any harms (KQ 2).

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

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 perinatal depression?
  2. When is the most effective time to provide interventions to prevent perinatal depression?

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 (KQs).

  Included Excluded
Aim/Objective Studies on counseling or pharmacologic interventions to prevent perinatal depression Studies restricted to screening for and treatment of depression during pregnancy or in the postpartum period
Populations
  • Pregnant women and mothers ≤1 year postpartum; may target women with mental health ymptoms or disorders (see exceptions under exclusion criteria)
  • A priori subpopulations of interest: adolescents, racial/ethnic minority women, women with a history of depressive disorders (including perinatal depression), women with anxiety disorders, women with low socioeconomic status, and single mothers
  • Studies limited to perinatal 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 imited 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 in mixed populations that include >50% of any of the above populations will be excluded
Interventions Counseling and pharmacologic interventions to reduce the risk of perinatal depression initiated during pregnancy or the first year postpartum, including:
  • Counseling (e.g., cognitive behavioral therapy, interpersonal psychotherapy, nondirective counseling, debriefing), psychoeducation, or other supportive interventions (e.g., peer mentoring, support group)
  • Care delivery models targeting improved mental health outcomes
  • 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 perinatal depression
  • Widely available physical activity or 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)
  • General parenting education without a mental health component (e.g., prenatal or infant care classes)
  • Other prophylactic medications
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
 Active intervention (i.e., comparative effectiveness)
Outcomes KQ 1: Maternal health outcomes:
  • Depression incidence or symptoms (required)
  • Suicide deaths, attempts, or ideation, including self-harm
  • Health-related quality of life, including stress and anxiety
  • Functioning, including maternal functioning
  • Health care utilization (e.g., emergency department visits, hospital admissions)
  • Breastfeeding
  • 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., emergency department visits, hospital admissions, neonatal intensive care unit stays/number of days)

KQ 2:

  • Reduced satisfaction with care
  • Care avoidance
  • Maternal or fetal/infant harms related to antidepressant use:
    • Gestational diabetes or metabolic effects
    • Preeclampsia
    • Vaginal bleeding or postpartum hemorrhage
    • Miscarriage or spontaneous abortion
    • Infant serotonin syndrome or serotonin withdrawal syndrome
    • Infant cardiac effects
    • Infant seizures or convulsions
    • Perinatal death
    • Preterm birth or early gestational age
    • Low birth weight or small for gestational age
    • Neonatal respiratory distress
    • Neonatal 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: ≥6 weeks after baseline assessment or intervention initiation

KQ 2: Any time after the intervention is initiated

 KQ 1: <6 weeks after baseline assessment or intervention initiation
Settings
  • 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 report, 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

The draft Research Plan was posted on the USPSTF Web site from May 19, 2016 to June 15, 2016. In response to public comments, the USPSTF expanded the scope of the review to include prevention of depression onset during pregnancy as well as the postnatal period, thus changing the focus from postpartum to perinatal depression prevention. In addition, the USPSTF expanded the allowable time window for intervention initiation and outcomes assessment and added more intervention modalities. Additional comments were addressed through clarification of the text.