Clinical trial NCT02935504: PRogram In Support of Moms (PRISM): A Pilot Study
Official title: PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: Depression
Pregnancy
Postpartum
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-10-17
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that aims to improve women's access to and participation in perinatal depression treatment and thereby improve depression outcomes

Detailed description: Major depressive disorder continues to be the leading cause of disability among women of reproductive age and major public health concern. Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, behavior and development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the majority of women are amenable to depression screening, screening alone does not improve treatment entry or outcome. Despite the availability of effective evidence-based treatments and frequent contact with obstetric providers, less than one-third of women who screen positive for depression receive treatment. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed a program called "PRogram In Support of Moms" (PRISM) that aims to leverage existing roles and resources to target patient, provider, and system level barriers to perinatal depression treatment. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. Four practices were randomly assigned to PRISM versus an active comparison group called MCPAP for Moms which is a state-wide telephonic perinatal psychiatry program. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 3 months postpartum among patients.

Eligibility criteria: Inclusion Criteria:

1. Female
2. Age 18-55 years
3. English speaking
4. 4-36 weeks gestational age (GA) or 2-12 weeks postpartum
5. Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
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 consent

Exclusion Criteria:

1. Lack of verbal and written English fluency
2. Under age 18 or over age 55
3. Current active substance use disorder
4. Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
5. Psychotic component to illness as determined by the M.I.N.I.

Primary outcomes:
measure: Depression Severity
timeFrame: Baseline to 10-35 weeks follow-up
Secondary outcomes:
measure: Provider Fidelity
timeFrame: Baseline to 1 year follow-up (post intervention)
Other outcomes:
Locations:
Study officials:
affiliation: • UMass Memorial Medical Center/UMass Medical School
name: Nancy Byatt, DO, MS, MBA
role: PRINCIPAL_INVESTIGATOR
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