PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
NCT ID: NCT02760004
Last Updated: 2024-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2017-10-11
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Prism Intervention
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM)
* Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
MCPAP for Moms Intervention
MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms)
MCPAP for Moms
* 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
Interventions
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PRogram In Support of Moms (PRISM)
* Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
MCPAP for Moms
* 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18-55 years
3. English speaking
4. \>4 weeks Gestational age (GA) until 4 months postpartum
5. Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)
6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10
7. Able to communicate in written and spoken English; and
8. Cognitively able to participate in informed verbal consent
Exclusion Criteria
2. Under age 18 or over age 55
3. substance use disorder as determined by the questions in 4 Ps questionnaire
4. Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
5. Prisoner
6. Women participating in 'Moms do care' study
18 Years
55 Years
FEMALE
No
Sponsors
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University of Massachusetts, Worcester
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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Nancy Byatt
Associate Professor of Psychiatry and Obstetrics & Gynecology
Principal Investigators
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Nancy Byatt, DO, MS, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Medical School/UMass Memorial Health Care
Tiffany A Moore Simas, MD, MPH, MEd
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Medical School/UMass Memorial Health Care
Jeroan J Allison, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Medical School/UMass Memorial Health Care
Locations
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UMass Medical School/UMass Memorial Medical Center
Worcester, Massachusetts, United States
Countries
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References
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Chen H, Wang J, Ch'ng YC, Mingoo R, Lee T, Ong J. Identifying mothers with postpartum depression early: integrating perinatal mental health care into the obstetric setting. ISRN Obstet Gynecol. 2011;2011:309189. doi: 10.5402/2011/309189. Epub 2011 Sep 15.
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Chaudron LH, Kitzman HJ, Peifer KL, Morrow S, Perez LM, Newman MC. Prevalence of maternal depressive symptoms in low-income Hispanic women. J Clin Psychiatry. 2005 Apr;66(4):418-23. doi: 10.4088/jcp.v66n0402.
Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.
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Myers ER, Aubuchon-Endsley N, Bastian LA, Gierisch JM, Kemper AR, Swamy GK, Wald MF, McBroom AJ, Lallinger KR, Gray RN, Green C, Sanders GD. Efficacy and Safety of Screening for Postpartum Depression [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC064-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137724/
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Karlson K, Holm A. Decomposing primary and secondary effects: A new decomposition method. Research in Social Stratification and Mobility 2011;29:221-37.
Julce C, Flahive J, Lightbourne T, Podila S, Mahanna A, Zimmermann M, Sheldrick RC, Moore Simas TA, Byatt N. Descriptive Characteristics of Psychiatric Medication Discontinuation Among Perinatal Women With Depressive Symptoms. Early Interv Psychiatry. 2025 Jun;19(6):e70070. doi: 10.1111/eip.70070.
Byatt N, Brenckle L, Sankaran P, Flahive J, Ko JY, Robbins CL, Zimmermann M, Allison J, Person S, Moore Simas TA. Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial. Lancet Public Health. 2024 Jan;9(1):e35-e46. doi: 10.1016/S2468-2667(23)00268-2.
Schipani Bailey E, Byatt N, Carroll S, Brenckle L, Sankaran P, Kroll-Desrosiers A, Smith NA, Allison J, Simas TAM. Results of a Statewide Survey of Obstetric Clinician Depression Practices. J Womens Health (Larchmt). 2022 May;31(5):675-681. doi: 10.1089/jwh.2021.0147. Epub 2021 Sep 2.
Masters GA, Brenckle L, Sankaran P, Person SD, Allison J, Moore Simas TA, Ko JY, Robbins CL, Marsh W, Byatt N. Positive screening rates for bipolar disorder in pregnant and postpartum women and associated risk factors. Gen Hosp Psychiatry. 2019 Nov-Dec;61:53-59. doi: 10.1016/j.genhosppsych.2019.09.002. Epub 2019 Oct 22.
Moore Simas TA, Brenckle L, Sankaran P, Masters GA, Person S, Weinreb L, Ko JY, Robbins CL, Allison J, Byatt N. 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 Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Comparing regression coefficients between models using logit and probit: a new method. Available online at Social Science Research Network, 2010. (Accessed Accessed August, 2011)
Total, direct, and indirect effects in logit models. 2010. (Accessed Accessed August, 2011
Other Identifiers
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H00009163
Identifier Type: -
Identifier Source: org_study_id
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