PRogram In Support of Moms (PRISM): A Pilot Study (PRISM-Pilot)
Primary Purpose
Perinatal Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRogram In Support of Moms (PRISM)
MCPAP for Moms
Sponsored by

About this trial
This is an interventional health services research trial for Perinatal Depression focused on measuring Depression, Pregnancy, Postpartum
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 18-55 years
- English speaking
- 4-36 weeks gestational age (GA) or 2-12 weeks postpartum
- Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
- Edinburgh Postnatal Depression Scale score (EPDS) ≥10
- Able to communicate in written and spoken English; and
- Cognitively able to participate in informed consent
Exclusion Criteria:
- Lack of verbal and written English fluency
- Under age 18 or over age 55
- Current active substance use disorder
- Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
- Psychotic component to illness as determined by the M.I.N.I.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Program In Support of Moms PRISM
MCPAP for Moms
Arm Description
PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.
Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts.
Outcomes
Primary Outcome Measures
Depression Severity
To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms.
Secondary Outcome Measures
Provider Fidelity
To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices.
Full Information
NCT ID
NCT02935504
First Posted
October 4, 2016
Last Updated
April 30, 2018
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02935504
Brief Title
PRogram In Support of Moms (PRISM): A Pilot Study
Acronym
PRISM-Pilot
Official Title
PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression
Keywords
Depression, Pregnancy, Postpartum
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Program In Support of Moms PRISM
Arm Type
Experimental
Arm Description
PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.
Arm Title
MCPAP for Moms
Arm Type
Active Comparator
Arm Description
Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts.
Intervention Type
Behavioral
Intervention Name(s)
PRogram In Support of Moms (PRISM)
Other Intervention Name(s)
Rapid Access to Perinatal Psychiatric care in Depression, RAPPID
Intervention Description
PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend:
Toolkit Care coordination Psychiatric consultation Implementation support
Engage clinic leaders and staff
Identify leadership group and prepare for change
Assess readiness to implement PRISM
Identify steps to achieve goals
Implement PRISM components into the clinic
Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention
Intervention Type
Behavioral
Intervention Name(s)
MCPAP for Moms
Intervention Description
MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals
Primary Outcome Measure Information:
Title
Depression Severity
Description
To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms.
Time Frame
Baseline to 10-35 weeks follow-up
Secondary Outcome Measure Information:
Title
Provider Fidelity
Description
To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices.
Time Frame
Baseline to 1 year follow-up (post intervention)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age 18-55 years
English speaking
4-36 weeks gestational age (GA) or 2-12 weeks postpartum
Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
Edinburgh Postnatal Depression Scale score (EPDS) ≥10
Able to communicate in written and spoken English; and
Cognitively able to participate in informed consent
Exclusion Criteria:
Lack of verbal and written English fluency
Under age 18 or over age 55
Current active substance use disorder
Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
Psychotic component to illness as determined by the M.I.N.I.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Byatt, DO, MS, MBA
Organizational Affiliation
• UMass Memorial Medical Center/UMass Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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PRogram In Support of Moms (PRISM): A Pilot Study
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