Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial.

BACKGROUND: Perinatal depression is a common and undertreated condition, with potential deleterious effects on maternal, obstetric, infant, and child outcomes. We aimed to compare the effectiveness of two systems-level interventions in the obstetric setting-the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the PRogram In Support of Moms (PRISM)-in improving depression symptoms and participation in mental health treatment among women with perinatal depression. METHODS: In this cluster-randomised, active-controlled trial, obstetric practices across Massachusetts (USA) were allocated (1:1) via covariate adaptive randomisation to either continue participating in the MCPAP for Moms intervention, a state-wide, population-based programme, or to participate in the PRISM intervention, which involved MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. English-speaking women (aged ≥18 years) who screened positive for depression (Edinburgh Postnatal Depression Scale [EPDS] score ≥10) were recruited from the practices. Patients were followed up at 4-25 weeks of gestation, 32-40 weeks of gestation, 0-3 months postpartum, 5-7 months postpartum, and 11-13 months postpartum via telephone interview. Participants were masked to the intervention; investigators were not masked. The primary outcome was change in depression symptoms (EPDS score) between baseline assessment and 11-13 months postpartum. Analysis was done by intention to treat, fitting generalised linear mixed models adjusting for age, insurance status, education, and race, and accounting for clustering of patients within practices. This trial is registered with ClinicalTrials.gov, NCT02760004. FINDINGS: Between July 29, 2015, and Sept 20, 2021, ten obstetric practices were recruited and retained; five (50%) practices were randomly allocated to MCPAP for Moms and five (50%) to PRISM. 1265 participants were assessed for eligibility and 312 (24·7%) were recruited, of whom 162 (51·9%) were enrolled in MCPAP for Moms practices and 150 (48·1%) in PRISM practices. Comparing baseline to 11-13 months postpartum, EPDS scores decreased by 4·2 (SD 5·2; p<0·0001) among participants in MCPAP for Moms practices and by 4·3 (SD 4.5; p<0·0001) among those in PRISM practices (estimated difference between groups 0·1 [95% CI -1·2 to 1·4]; p=0·87). INTERPRETATION: Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms. This finding is important because the 4-point decrease in EPDS score is clinically significant, and MCPAP for Moms has a lower intensity and greater population-based reach than does PRISM. FUNDING: US Centers for Disease Control and Prevention.

Results of a Statewide Survey of Obstetric Clinician Depression Practices.

Purpose: Perinatal depression affects upwards of one in seven women and is associated with significant negative maternal and child consequences. Despite this, it remains under-detected and under-treated. We sought to identify clinician practices, self-efficacy, and remaining barriers to comprehensively addressing perinatal depression care. Materials and Methods: Surveys were administered to obstetric clinicians in Massachusetts that queried frequency of depression screening and Likert questions about subsequent depression management. Results: Approximately 79.0% of clinicians approached completed the survey. Whereas most clinicians (93.5%) screened for perinatal depression at 6 weeks postpartum, fewer clinicians (66.1%) screened during pregnancy. Most reported they were comfortable providing support to their patients (98.4%), but fewer endorsed being able to treat them on their own (43.0%). Most noted an ability to treat with antidepressants (77.9%); however, fewer endorsed adequate access to nonmedication treatment (45.5%). Conclusions: The majority of surveyed clinicians screen for depression consistent with guidelines. However, efforts are focused on the postpartum period, despite literature citing two-thirds of patients experiencing onset before or during pregnancy. Respondents indicated an ability to treat with medication management, while noting greater challenge with referral. These findings describe the challenges of interdisciplinary coordination as a barrier to comprehensive perinatal mental health care. Clinical Trial Registration Number: NCT02760004.

Development of the Practice Readiness to Evaluate and address Perinatal Depression (PREPD) assessment.

OBJECTIVE: Perinatal depression is a common pregnancy complication and universal screening is recommended. The Practice Readiness to Evaluate and address Perinatal Depression (PREPD) was developed to measure obstetric practice readiness to integrate depression care into workflows. Objectives were to describe: (1) the PREPD; (2) associated characteristics by readiness level; and (3) use of the assessment to measure change. METHOD: The PREPD has four components, each scored to a 16-point maximum: (1) Environmental Scan (10% of PREPD); (2) Depression Detection, Assessment, and Treatment Questionnaire (30%); (3) Depression-related Policies Questionnaire (10%); and (4) Chart Abstraction (50%). Components were weighted and summed for an overall score. Summary and component scores were calculated by patient, practice, and provider. RESULTS: Average overall PREPD score was 7.3/16 (range: 4.8-9.9); scores varied between practices. The Environmental Scan averaged 2.0/16 (range: 0-5.2); Detection, Assessment, and Treatment averaged 8.3/16 (range: 3.0-11.5); Chart Abstraction averaged 7.2/16 (range: 5.1-9.6); and Depression-related Policies averaged 10.4/16 (range: 7.5-15). CONCLUSION: We found wide variation in obstetric practices' readiness to implement interventions for depression; most were minimally prepared. These data may be used to tailor practice intervention goals and as benchmarks with which to measure changes in integration of depression care over time.

Positive screening rates for bipolar disorder in pregnant and postpartum women and associated risk factors.

OBJECTIVE: Bipolar disorder affects 2-8% of pregnant and postpartum women; untreated illness is associated with poor outcomes. This study aimed to describe bipolar disorder screening rates in obstetric settings and associated characteristics. METHOD: Women were recruited during pregnancy through three months postpartum from 14 obstetric clinics in Massachusetts. The Mood Disorder Questionnaire (MDQ) was used to screen for bipolar disorder; a subset previously diagnosed with bipolar was also examined. Differences in characteristics by screening outcome were tested using chi-square and t-tests. RESULTS: Of 574 participating women, 18.8% screened positive for bipolar disorder. Compared to those with negative, those with positive bipolar screens had 18.5-times the prevalence of positive substance use screens (11.1% vs. 0.6%, p < 0.001) and 3.4-times reported feeling they were not receiving adequate psychiatric help (24.0 vs. 7.0%, p < 0.001). Less than half of those with positive bipolar screens (42.0%) and 61.3% with pre-existing bipolar reported receiving current psychiatric care. CONCLUSIONS: Almost one in five perinatal women screened positive for bipolar disorder. Positive screenings were associated with comorbid substance use and low treatment rates. This study highlights the importance of screening for bipolar disorder during the perinatal period and the need for systematic approaches to ensure adequate assessment and follow-up. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT02760004.

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.

BACKGROUND: Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support. METHODS: This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm. DISCUSSION: This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.

How obstetric settings can help address gaps in psychiatric care for pregnant and postpartum women with bipolar disorder.

To elucidate (1) the challenges associated with under-recognition of bipolar disorder in obstetric settings, (2) barriers pregnant and postpartum women with bipolar disorder face when trying to access psychiatric care, and (3) how obstetric settings can identify such women and connect them with mental health services. Structured, in-depth interviews were conducted with 25 pregnant and postpartum women recruited from obstetric practices who scored ≥ 10 on the Edinburgh Postnatal Depression Scale and met DSM-IV criteria for bipolar disorder I, II, or not otherwise specified using the Mini International Neuropsychiatric Interview. Quantitative analyses included descriptive statistics. Interviews were transcribed, and resulting data were analyzed using a grounded theory approach. Most participants (n = 19, 79.17%) did not have a clinical diagnosis of bipolar disorder documented in their medical records nor had received referral for treatment during pregnancy (n = 15, 60%). Of participants receiving pharmacotherapy (n = 14, 58.33%), most were treated with an antidepressant alone (n = 10, 71.42%). Most medication was prescribed by an obstetric (n = 4, 28.57%) or primary care provider (n = 7, 50%). Qualitative interviews indicated that participants want their obstetric practices to proactively screen for, discuss and help them obtain mental health treatment. Women face challenges in securing mental health treatment appropriate to their bipolar illness. Obstetric providers provide the bulk of medical care for these women and need supports in place to (1) better recognize bipolar disorder, (2) avoid inappropriate prescribing practices for women with undiagnosed bipolar disorder, and (3) ensure women are referred to specialized treatment when needed.

Access to Pharmacotherapy Amongst Women with Bipolar Disorder during Pregnancy: a Preliminary Study.

Bipolar disorder among pregnant women has deleterious effects on birth and child outcomes and is currently under-detected, not addressed effectively, or exacerbated through inappropriate treatment. The goal of this study was to identify perspectives of pregnant and postpartum women with bipolar disorder on barriers and facilitators to psychiatric treatment during pregnancy. In-depth interviews were conducted with pregnant and postpartum women who scored ≥ 10 on the Edinburgh Postnatal Depression Scale and met DSM-IV criteria for bipolar disorder I, II or not otherwise specified using the Mini International Neuropsychiatric Interview version 5.0. Interviews were transcribed, and resulting data were analyzed using a grounded theory approach to identify barriers and facilitators to bipolar disorder treatment access in pregnancy. Participant identified barriers included perception that psychiatric providers lack training and experience in the treatment of psychiatric illness during pregnancy, are reluctant to treat bipolar disorder among pregnant women, and believe that pharmacotherapy is not needed for psychiatric illness during pregnancy. Facilitators included participants' perception that providers' acknowledge risks associated with untreated or undertreated psychiatric illness during pregnancy and provide psycho-education about the risks, benefits and alternatives to pharmacotherapy. Psychiatric providers are critically important to the treatment of bipolar disorder and need knowledge and skills necessary to provide care during the perinatal period. Advancing psychiatric providers' knowledge/skills may improve access to pharmacotherapy for pregnant women with bipolar disorder.

PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women.

PURPOSE: This pilot study was designed to inform a larger effectiveness trial by: (1) assessing the feasibility of the PRogram In Support of Moms (PRISM) and our study procedures; and, (2) determining the extent to which PRISM as compared to an active comparison group, the Massachusetts Child Access Psychiatry Program (MCPAP) for Moms alone, improves depression among perinatal women. METHODS: Four practices were randomized to either PRISM or MCPAP for Moms alone, a state-wide telephonic perinatal psychiatry program. PRISM includes MCPAP for Moms plus implementation assistance with local champions, training, and implementation of office prompts and procedures to enhance depression screening, assessment and treatment. Patients with Edinburgh Postnatal Depression Scales (EPDS) ≥ 10 were recruited during pregnancy, and completed the EPDS and a structured interview at baseline and 3-12 weeks' postpartum. RESULTS: Among MCPAP for Moms alone practices, patients' (n = 9) EPDS scores improved from 15.22 to 10.11 (p = 0.010), whereas in PRISM practices patients' (n = 21) EPDS scores improved from 13.57 to 6.19 (p = 0.001); the between groups difference-of-differences was 2.27 (p = 0.341). CONCLUSIONS: PRISM was beneficial for patients, clinicians, and support staff. Both PRISM and MCPAP for Moms alone improve depression symptom severity and the percentage of women with an EPDS >10. The improvement difference between groups was not statistically significant due to limited power associated with small sample size.