Depression
Conditions
Keywords
Depression
Brief 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.
Detailed description
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, and children's behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the vast majority of perinatal women are amenable to being screened for depression, screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a comprehensive intervention that is proactive, multifaceted, and practical. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to immediate resource provision/referrals and 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. PRISM builds on a low-cost and widely disseminated population-based model for delivering psychiatric care in primary care settings developed by our team. Because it uses existing infrastructure and resources, PRISM, has the potential to be feasible, sustainable, and transportable to other practice settings. The Investigators will compare PRISM vs. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group).
Interventions
BEHAVIORALPRogram 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
BEHAVIORALMCPAP 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
Sponsors
Centers for Disease Control and Prevention
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Female 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
1. Lack of verbal and written English fluency 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edinburgh Postnatal Depression Scale Score (EPDS) | Baseline up to 13 months postpartum | EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Initiating Treatment | Baseline to up to 13 months postpartum | Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms. |
| Participants Sustaining Mental Health Treatment | Baseline to up to 13 months postpartum | Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from the 10 participating OB/Gyn practices from October 2017 to November 2020. The 10 obstetric practices were randomized to one of the two interventions (5 each) and patient participants from these practices provided data for evaluating the effectiveness of each intervention. Individual patient participant data were analyzed to assess effectiveness.
Pre-assignment details
Of the 1265 screened, 312 met the inclusion criteria. The practices were randomized to the 2 intervention arms of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 150 |
| MCPAP for Moms MCPAP for Moms
Access to 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 | 162 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 22 |
Baseline characteristics
| Characteristic | PRISM Intervention | Total | MCPAP for Moms |
|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 6 | 32 years STANDARD_DEVIATION 6 | 33 years STANDARD_DEVIATION 6 |
| Education Associate degree | 8 Participants | 23 Participants | 15 Participants |
| Education Bachelor's degree | 30 Participants | 51 Participants | 21 Participants |
| Education Doctoral degree or equivalent | 0 Participants | 15 Participants | 15 Participants |
| Education Grade school/Some high school | 9 Participants | 15 Participants | 6 Participants |
| Education High school diplomaor GED equivalent | 46 Participants | 78 Participants | 32 Participants |
| Education Master's degree | 22 Participants | 51 Participants | 29 Participants |
| Education Other - Missing data | 1 Participants | 2 Participants | 1 Participants |
| Education Some college no degree | 34 Participants | 77 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 91 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 219 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Primary source of payment for prenatal care Medicaid/Mass Health/Other public | 86 Participants | 164 Participants | 78 Participants |
| Primary source of payment for prenatal care Private or Commercial | 61 Participants | 143 Participants | 82 Participants |
| Primary source of payment for prenatal care Tricare/Self-pay/Other | 2 Participants | 4 Participants | 2 Participants |
| Primary source of payment for prenatal care Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 20 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 39 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 27 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 37 Participants | 15 Participants |
| Race (NIH/OMB) White | 82 Participants | 184 Participants | 102 Participants |
| Region of Enrollment United States | 150 participants | 312 participants | 162 participants |
| Sex: Female, Male Female | 150 Participants | 312 Participants | 162 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 162 |
| other Total, other adverse events | 0 / 150 | 1 / 162 |
| serious Total, serious adverse events | 0 / 150 | 0 / 162 |
Outcome results
Primary
Change in Edinburgh Postnatal Depression Scale Score (EPDS)
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
Time frame: Baseline up to 13 months postpartum
Population: Out of the participants enrolled in the study, data was obtained and analyzed for 118 participants in the PRISM Intervention and 117 in the MCPAP for Moms for this outcome measure. These subgroups are based on the number of Participants who had both the baseline EPDS score and a final 11-13 months postpartum EPDS score. Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Change in Edinburgh Postnatal Depression Scale Score (EPDS) | -4.3 score on a scale | Standard Deviation 4.5 |
| MCPAP for Moms | Change in Edinburgh Postnatal Depression Scale Score (EPDS) | -4.2 score on a scale | Standard Deviation 5.2 |
Secondary
Participants Initiating Treatment
Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Time frame: Baseline to up to 13 months postpartum
Population: Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRISM Intervention | Participants Initiating Treatment | 78 Participants |
| MCPAP for Moms | Participants Initiating Treatment | 70 Participants |
Secondary
Participants Sustaining Mental Health Treatment
Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Time frame: Baseline to up to 13 months postpartum
Population: Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRISM Intervention | Participants Sustaining Mental Health Treatment | 38 Participants |
| MCPAP for Moms | Participants Sustaining Mental Health Treatment | 32 Participants |