Abstract
BackgroundPerinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support.MethodsThis study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3–5 total study visits depending on whether their initial recruitment and interview was at 4–24 or 32–40 weeks gestation, or 1–3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm.DiscussionThis manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.Trial registrationClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.
Highlights
Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes
Despite being associated with negative maternal [2], birth [3], infant [4] and child outcomes [5,6,7], which are mitigated by effective treatment [8] that includes psychopharmacology and psychotherapy [9], perinatal depression remains under-diagnosed [10,11,12,13] and under-treated [14]
The aim of this paper is to describe the methods of a large-scale, multi-site cluster-randomized controlled trial (RCT) study protocol comparing two active interventions in addressing perinatal depression in obstetric settings
Summary
The most common pregnancy complication, is associated with negative maternal-offspring outcomes. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Despite being associated with negative maternal [2], birth [3], infant [4] and child outcomes [5,6,7], which are mitigated by effective treatment [8] that includes psychopharmacology and psychotherapy [9], perinatal depression remains under-diagnosed [10,11,12,13] and under-treated [14]. Provider and systems-level barriers include: (a) lack of obstetric provider training in technical aspects of depression care [20,21,22] and relevant communication skills [23]; (b) absence of standardized processes and procedures for integrateding obstetric and depression care [23, 24]; (c) lack of mental health providers willing to treat pregnant women [24]; (d) lack of referral networks [23,24,25,26,27]; and, (e) inadequate capacity and resources to ensure depression evaluation, treatment, followup, and care coordination [23,24,25,26,27,28,29]
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