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N/A N=312 Randomized Single-blind Health Services Research

PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics

Depression

Bottom Line

View on ClinicalTrials.gov: NCT02760004 ↗
Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Edinburgh Postnatal Depression Scale Score (EPDS) — -4.3; -4.2 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PRogram In Support of Moms (PRISM) (Behavioral); MCPAP for Moms (Behavioral)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Massachusetts, Worcester
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Edinburgh Postnatal Depression Scale Score (EPDS)		 -4.3; -4.2 —
SECONDARY
Participants Initiating Treatment		 78; 70 —
SECONDARY
Participants Sustaining Mental Health Treatment		 38; 32 —

Summary

The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth.

Eligibility Criteria

Inclusion Criteria

  • Female
  • Age 18-55 years
  • English speaking
  • >4 weeks Gestational age (GA) until 4 months postpartum
  • 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)
  • Edinburgh Postnatal Depression Scale score (EPDS) ≥10
  • Able to communicate in written and spoken English; and
  • Cognitively able to participate in informed verbal consent

Exclusion Criteria

  • Lack of verbal and written English fluency
  • Under age 18 or over age 55
  • substance use disorder as determined by the questions in 4 Ps questionnaire
  • Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
  • Prisoner
  • Women participating in 'Moms do care' study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02760004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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