Department of Obstetrics and Gynecology; Department of Psychiatry; Department of Quantitative Health Sciences; Department of Family Medicine and Community Health; Graduate School of Biomedical Sciences; Implementation Science and Practice Advances Research Center
Female Urogenital Diseases and Pregnancy Complications | Health Services Administration | Health Services Research | Maternal and Child Health | Mental and Social Health | Obstetrics and Gynecology | Psychiatry | Psychiatry and Psychology | Women's Health
BACKGROUND: Perinatal 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.
METHODS: This 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.
DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.
Depression, Implementation randomized controlled trial, Integrated care, Intervention, Methods, Perinatal, Postpartum, Pregnancy, Protocol
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© The Author(s). 2019 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI of Published Version
BMC Pregnancy Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3. Link to article on publisher's site
BMC pregnancy and childbirth
Moore Simas, Tiffany A.; Brenckle, Linda; Sankaran, Padma; Masters, Grace A.; Person, Sharina D.; Weinreb, Linda; Ko, Jean Y.; Robbins, Cheryl L.; Allison, Jeroan J.; and Byatt, Nancy, "The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings" (2019). Psychiatry Publications and Presentations. 840.
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This work is licensed under a Creative Commons Attribution 4.0 License.
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