Abstract
BackgroundStress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being.Methods/DesignThe purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes.Trial registrationClinicalTrials.gov Identifier: NCT01901796
Highlights
Stress, depression, and anxiety affect 15 to 25% of pregnant women
Prenatal mental health problems Depression, anxiety, and stress are common in pregnancy
Anxiety, and stress are severely under detected and under treated, and two-thirds of women with substantial symptoms remain unidentified by most obstetrical providers [20,21]
Summary
Prenatal mental health problems Depression, anxiety, and stress are common in pregnancy. The predominant limitations of existing studies of integrated perinatal mental care (and areas we aim to improve upon) are: 1) all lacked a comparison group; 2) all primarily targeted depression without addressing stress and anxiety; 3) most conducted a minimal feasibility assessment, providing little guidance for improving the intervention or understanding its most effective components; 4) none evaluated clinical outcomes; 5) none used technological (for example, web-based) approaches to support integrated care, recommended as a key element of success of integrated care [41]; and 6) none targeted the most prominent barriers to mental healthcare reported by providers (for example, lack of time to screen, lack of screening tools and knowledge regarding their use, lack of referral mechanisms, unavailable and inaccessible nonpharmacological therapies) [28,47,48] or by pregnant/ postpartum women (lack of time, preference for working through their symptoms on their own, stigma associated with treatment, inability to find/access/afford nonpharmacologic therapy) [22,24,37] Together, these limitations highlight the lack of utility that current research offers in terms of implementing integrated psychosocial care in clinical settings. Research questions The research objectives, primary and secondary research questions, and hypotheses associated with the four identified knowledge gaps are described in Tables 1 and 2
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