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
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 ba...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-07-01
|
| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12884-019-2387-3 |
| _version_ | 1818246402469265408 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Tiffany A. Moore Simas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T14:48:14Z |
| format | Article |
| id | doaj.art-31c51168ff94401083f3db343b766b37 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-12T14:48:14Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-31c51168ff94401083f3db343b766b372022-12-22T00:21:04ZengBMCBMC Pregnancy and Childbirth1471-23932019-07-0119111310.1186/s12884-019-2387-3The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settingsTiffany A. Moore Simas0Linda Brenckle1Padma Sankaran2Grace A. Masters3Sharina Person4Linda Weinreb5Jean Y. Ko6Cheryl L. Robbins7Jeroan Allison8Nancy Byatt9University of Massachusetts Medical SchoolDepartment of Psychiatry, University of Massachusetts Medical SchoolDepartment of Psychiatry, University of Massachusetts Medical SchoolUniversity of Massachusetts Medical SchoolUniversity of Massachusetts Medical SchoolDepartment of Family Medicine and Community Health, University of Massachusetts Medical SchoolCenters for Disease Control and PreventionCenters for Disease Control and PreventionUniversity of Massachusetts Medical SchoolUniversity of Massachusetts Medical SchoolAbstract 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.http://link.springer.com/article/10.1186/s12884-019-2387-3PregnancyPostpartumPerinatalDepressionIntegrated careMethods |
| spellingShingle | 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 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 BMC Pregnancy and Childbirth Pregnancy Postpartum Perinatal Depression Integrated care Methods |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | program in support of moms prism study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings |
| topic | Pregnancy Postpartum Perinatal Depression Integrated care Methods |
| url | http://link.springer.com/article/10.1186/s12884-019-2387-3 |
| work_keys_str_mv | AT tiffanyamooresimas theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT lindabrenckle theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT padmasankaran theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT graceamasters theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT sharinaperson theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT lindaweinreb theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT jeanyko theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT cheryllrobbins theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT jeroanallison theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT nancybyatt theprograminsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT tiffanyamooresimas programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT lindabrenckle programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT padmasankaran programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT graceamasters programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT sharinaperson programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT lindaweinreb programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT jeanyko programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT cheryllrobbins programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT jeroanallison programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings AT nancybyatt programinsupportofmomsprismstudyprotocolforaclusterrandomizedcontrolledtrialoftwoactiveinterventionsaddressingperinataldepressioninobstetricsettings |