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.
Adult
Cluster Analysis
Depression
/ diagnosis
Depression, Postpartum
/ diagnosis
Female
Humans
Mental Health
Outcome Assessment, Health Care
Patient Participation
Perinatal Care
/ methods
Pregnancy
Pregnancy Complications
/ diagnosis
Psychological Techniques
Psychosocial Support Systems
Research Design
Depression
Implementation randomized controlled trial
Integrated care
Intervention
Methods
Perinatal
Postpartum
Pregnancy
Protocol
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
22 Jul 2019
22 Jul 2019
Historique:
received:
31
05
2018
accepted:
30
06
2019
entrez:
24
7
2019
pubmed:
25
7
2019
medline:
14
1
2020
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.
Identifiants
pubmed: 31331292
doi: 10.1186/s12884-019-2387-3
pii: 10.1186/s12884-019-2387-3
pmc: PMC6647165
doi:
Banques de données
ClinicalTrials.gov
['NCT02760004']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
256Subventions
Organisme : NCRR NIH HHS
ID : KL2TR000160
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1TR000161
Pays : United States
Organisme : CDC HHS
ID : 1U01 DP006093
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1TR001453
Pays : United States
Organisme : NCCDPHP CDC HHS
ID : U01 DP006093
Pays : United States
Organisme : NCATS NIH HHS
ID : TL1 TR001454
Pays : United States
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