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

Tiffany A Moore Simas, Linda Brenckle, Padma Sankaran, Grace A Masters, Sharina Person, Linda Weinreb, Jean Y Ko, Cheryl L Robbins, Jeroan Allison, Nancy Byatt, Tiffany A Moore Simas, Linda Brenckle, Padma Sankaran, Grace A Masters, Sharina Person, Linda Weinreb, Jean Y Ko, Cheryl L Robbins, Jeroan Allison, Nancy Byatt

Abstract

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.

Keywords: Depression; Implementation randomized controlled trial; Integrated care; Intervention; Methods; Perinatal; Postpartum; Pregnancy; Protocol.

Conflict of interest statement

TMS receives grant funding from The Centers for Disease Control and Prevention (CDC U01DP006093) and the National Institute of Health (NIH R41 MH113381) for projects related to perinatal depression. TMS receives a stipend from the Massachusetts Department of Mental Health via Beacon for her role as Engagement Director of the Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms). TMS is medical director of Lifeline4Moms. TMS co-directs the American College of Obstetricians and Gynecologists’ Expert Work Group on Maternal Mental Health and was a member of the Council on Patient Safety in Women’s Health Care’s task force for creation of the maternal mental health patient safety bundle and co-author on the associated commentary. TMS has served on ad hoc Physician Advisory Boards for Sage Therapeutics, has received speaking honoraria, and serves as a consultant on observational studies and a systematic review. TMS serves as a consultant to Ovia Health, has received compensation for reviewing a perinatal depression case for McGraw Hill, and has received speaking honoraria from Miller Medical Communications. NB receives grant funding from The Centers for Disease Control and Prevention (CDC U01DP006093) and the National Institute of Health (NIH R41 MH113381) for projects related to perinatal depression. NB is the founding and current Medical Director of the Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms) and receives salary support from the Massachusetts Department of Mental Health for that role. NB is the Executive Director of Lifeline4Moms. NB is a member of the American College of Obstetricians and Gynecologists’ Expert Work Group on Maternal Mental Health. NB has served as a consultant for Sage Therapeutics or their agents. She has also received speaking honoraria for Sage Therapeutics and has served on Advisory Boards. NB is also a council member of the Gerson Lerhman Group and has served on an Advisory Board for Jannsen. NB has served as a consultant to Ovia Health and has received honoraria from Miller Medical Communications and Medscape.

For the remaining authors no completing interests were declared.

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