Impact of prenatal maternal depression on gestational length: post hoc analysis of a randomized clinical trial.

Background: Shortened gestation is a leading cause of childhood morbidity and mortality with lifelong consequences for health. There is a need for public health initiatives on increasing gestational age at birth. Prenatal maternal depression is a pervasive health problem robustly linked via correlational and epidemiological studies to shortened gestational length. This proof-of-concept study tests the impact of reducing prenatal maternal depression on gestational length with analysis of a randomized clinical trial (RCT). Methods: Participants included 226 pregnant individuals enrolled into an RCT and assigned to receive either interpersonal psychotherapy (IPT) or enhanced usual care (EUC). Recruitment began in July 2017 and participants were enrolled August 10, 2017 to September, 8 2021. Depression diagnosis (Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; DSM 5) and symptoms (Edinburgh Postnatal Depression Scale and Symptom Checklist) were evaluated at baseline and longitudinally throughout gestation to characterize depression trajectories. Gestational dating was collected based on current guidelines via medical records. The primary outcome was gestational age at birth measured dichotomously (≥39 gestational weeks) and the secondary outcome was gestational age at birth measured continuously. Posthoc analyses were performed to test the effect of reducing prenatal maternal depression on gestational length. This trial is registered with ClinicalTrials.gov (NCT03011801). Findings: Steeper decreases in depression trajectories across gestation predicted later gestational age at birth, specifically an increase in the number of full-term babies born ≥39 gestational weeks (EPDS linear slopes: OR = 1.54, 95% CI 1.10-2.16; and SCL-20 linear slopes: OR = 1.67, 95% CI 1.16-2.42). Causal mediation analyses supported the hypothesis that participants assigned to IPT experienced greater reductions in depression symptom trajectories, which in turn, contributed to longer gestation. Supporting mediation, the natural indirect effect (NIE) showed that reduced depression trajectories resulting from intervention were associated with birth ≥39 gestational weeks (EPDS, OR = 1.65, 95% CI 1.02-2.66; SCL-20, OR = 1.85, 95% CI 1.16-2.97). Interpretation: We used a RCT design and found that reducing maternal depression across pregnancy was associated with lengthened gestation. Funding: This research was supported by the NIH (R01 HL155744, R01 MH109662, R21 MH124026, P50 MH096889).

Interpersonal Psychotherapy's problem areas as an organizing framework to understand depression and sexual and reproductive health needs of Kenyan pregnant and parenting adolescents: a qualitative study.

BACKGROUND: Peripartum adolescents experience significant interpersonal transitions in their lives. Depression and emotional distress are often exacerbated by adolescents' responses to these interpersonal changes. Improved understanding of pregnancy-related social changes and maladaptive responses to these shifts may inform novel approaches to addressing the mental health needs of adolescents during the perinatal period. The paper aims to understand the sources of psychological distress in peripartum adolescents and map these to Interpersonal Psychotherapy's (IPT) problem areas as a framework to understand depression. METHOD: We conducted interviews in two Nairobi primary care clinics with peripartum adolescents ages 16-18 years (n = 23) with experiences of depression, keeping interpersonal psychotherapy framework of problem areas in mind. We explored the nature of their distress, triggers, antecedents of distress associated with an unplanned pregnancy, quality of their relationships with their partner, parents, and other family members, perceived needs, and sources of support. RESULTS: We found that the interpersonal psychotherapy (IPT) framework of interpersonal problems covering grief and loss, role transitions, interpersonal disputes, and social isolation was instrumental in conceptualizing adolescent depression, anxiety, and stress in the perinatal period. CONCLUSION: Our interviews deepened understanding of peripartum adolescent mental health focusing on four IPT problem areas. The interpersonal framework yields meaningful information about adolescent depression and could help in identifying strategies for addressing their distress.

Acceptability of virtual therapy for postpartum women during COVID-19: A national mixed methods study.

Background: Postpartum depression (PPD) affects one in eight women in the U.S., with rates increasing due to the COVID-19 pandemic. Given the unique circumstances of COVID-19, virtual therapy might be a unique way to overcome barriers to mental health services. The study sought to explore the acceptability of virtual therapy among women in the postpartum period. Methods: Using an online recruitment mixed methods approach, we collected data from a U.S. national cross-sectional sample of women (N = 479) who gave birth in the last 12 months. Findings: Results show that 66% of women endorsed items consistent with possible depression during the COVID-19 pandemic. Only 27% accessed therapy services during the postpartum period. While 88% were open to engaging in virtual therapy services, 12% identified several major concerns with virtual therapy, namely: (1) preference for in-person therapy (2) no perceived need for therapy (3) uncomfortable with virtual therapy, and (4) lack of privacy. Of note, 36% more Latinas reported dissatisfaction with quality of care received during virtual therapy compared to non-Latina participants. Despite a major shift to virtual care with COVID-19, future work is needed to make virtual mental health services more accessible for women with PPD.

Effectiveness of collaborative care in reducing suicidal ideation: An individual participant data meta-analysis.

To assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. METHOD: We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. RESULTS: We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I2, 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). CONCLUSION: Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most.

Change Mechanisms in Brief Interpersonal Psychotherapy for Women With Perinatal Depression: Qualitative Study.

OBJECTIVE: Brief interpersonal psychotherapy (IPT-B) has been shown to be effective in treating perinatal depression and in preventing depressive relapse among socioeconomically disadvantaged women. Yet, it is unclear how IPT-B alleviates depression. Previous research has suggested four possible change mechanisms derived from IPT's interpersonal model: decreasing interpersonal stress, facilitating emotional processing, improving interpersonal skills, and enhancing social support. This study explored how women who received IPT-B or enhanced maternity support services (MSS-Plus) evaluated their respective experiences. METHODS: A qualitative study was conducted with 16 women who had been recruited from public health clinics to participate in a larger, randomized controlled trial of women with major depression or dysthymia and who had been assigned to receive IPT-B or MSS-Plus. The sample was 63% non-Hispanic White, had an average age of 31.6 years, and was balanced in intervention group assignment, posttraumatic stress disorder status, and depression improvement. Telephone interviews included semistructured, open-ended questions eliciting participants' experiences with depression treatment. Predetermined, conceptually derived codes were based on the four postulated IPT change mechanisms. RESULTS: Thematic coded excerpts were collected and discussed. Excerpts lent support to the role of IPT-B in helping women decrease their interpersonal stress; identify, reflect on, and regulate their emotions; and improve their social skills. Evidence for increasing social support was mixed but highlighted the importance of the therapeutic relationship. CONCLUSIONS: Including qualitative findings into training in public health and other clinical settings will help illuminate the role of the provider in facilitating the change mechanisms that may lead to improved mental health among clients.

Mental health of pregnant and postpartum women in response to the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has been uniquely challenging for pregnant and postpartum women. Uncontrollable stress amplifies risk for maternal depression and anxiety, which are linked to adverse mother and child outcomes. This study examined change in internalizing symptoms from before to during the COVID-19 pandemic among pregnant and postpartum women longitudinally, and investigated moderation by loneliness and other contextual risk factors. METHODS: 135 women (M age = 31.81; 26% Latina, 55% non-Hispanic White, 11% Black; 39% low-income) enrolled in an existing prospective study completed self-report questionnaires including the EPDS and STAI-short form during early pregnancy, prior to COVID-19, and during COVID-19. RESULTS: Depressive symptoms were higher during COVID-19 compared to pre-COVID-19 and just as high as during early pregnancy. Anxiety symptoms were higher during COVID-19 compared to both pre-COVID-19 and early pregnancy. Higher loneliness was associated with increased depressive symptoms during COVID-19. Greater COVID-19 specific adversity was linked to greater increases in internalizing symptoms during COVID-19. Lower income-to-needs-ratio most strongly predicted symptoms during early pregnancy. LIMITATIONS: The present study is longitudinal, but the correlational nature of the data precludes causal conclusions regarding the effect of the pandemic on mental health. CONCLUSION: Longitudinal analyses suggest the COVID-19 pandemic resulted in increased internalizing symptoms among diverse pregnant and postpartum women. Interpersonal and contextual factors exacerbate risk and the impact of the pandemic on women's mental health. Identifying mothers at-risk for depression and anxiety may increase treatment utilization, mitigate fetal and infant exposure to maternal depression and anxiety, and help prevent adverse child outcomes.

Implementation of perinatal collaborative care: a health services approach to perinatal depression care.

AIM: Our objective was to integrate lessons learned from perinatal collaborative care programs across the United States, recognizing the diversity of practice settings and patient populations, to provide guidance on successful implementation. BACKGROUND: Collaborative care is a health services delivery system that integrates behavioral health care into primary care. While efficacious, effectiveness requires rigorous attention to implementation to ensure adherence to the core evidence base. METHODS: Implementation strategies are divided into three pragmatic stages: preparation, program launch, and program growth and sustainment; however, these steps are non-linear and dynamic. FINDINGS: The discussion that follows is not meant to be prescriptive; rather, all implementation tasks should be thoughtfully tailored to the unique needs and setting of the obstetric community and patient population. In particular, we are aware that implementation on the level described here assumes commitment of both effort and money on the part of clinicians, administrators, and the health system, and that such financial resources are not always available. We conclude with synthesis of a survey of existing collaborative care programs to identify implementation practices of existing programs.

Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial.

Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343). Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, -12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.

Preconception Health Risk Factors in Women with and without a History of Military Service.

INTRODUCTION: Given the increasing number of women service members and veterans of childbearing age, it is important to understand the preconception risks in this potentially vulnerable population. This study compared the prevalence of modifiable preconception risk factors among women with and without a history of service. METHODS: Analyses included data from the 2013 and 2014 Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. Preconception risk factors included health behaviors, chronic conditions, and mental health among women of childbearing age. Multivariate logistic regressions were used to compare the adjusted prevalence of each outcome among women with and without a history of service. Interaction terms assessed variation by age and history of service. RESULTS: Compared with women without a history of service, women with a history of service reported higher prevalence of insufficient sleep (49.6% vs. 36.3%; p < .001) and diagnosed depression (26.5% vs. 21.6%; p < .01). Women with a history of service were overall less likely to have obesity (19.8% vs. 26.5%; p < .001). Age-stratified results suggested that, compared with women without a history of service, women with a history of service were more likely to smoke in the 25 to 34 age group and reported comparable levels of obesity in the 35 to 44 age group. CONCLUSIONS: Women with a history of service demonstrated a preconception health profile that differs from women without a history of service. It is critical that providers are aware of their patients' military status and potential associated risks.

Adversities and mental health needs of pregnant adolescents in Kenya: identifying interpersonal, practical, and cultural barriers to care.

BACKGROUND: Adolescent pregnancies present a great public health burden in Kenya and Sub-Saharan Africa (UNFPA, Motherhood in Childhood: Facing the challenge of Adolescent Pregnancy, 2013). The disenfranchisement from public institutions and services is further compounded by cultural stigma and gender inequality creating emotional, psychosocial, health, and educational problems in the lives of vulnerable pregnant adolescents (Int J Adolesc Med Health 15(4):321-9, 2003; BMC Public Health 8:83, 2008). In this paper we have applied an engagement interview framework to examine interpersonal, practical, and cultural challenges faced by pregnant adolescents. METHODS: Using a qualitative study design, 12 pregnant adolescents (ages 15-19) visiting a health facility's antenatal services in Nairobi were interviewed. All recruited adolescents were pregnant for the first time and screened positive on the nine-item Patient Health Questionnaire (PHQ-9) with 16% of 176 participants interviewed in a descriptive survey in the same Kangemi primary health facility found to be severely depressed (Osok et al., Depression and its psychosocial risk factors in pregnant Kenyan adolescents: a cross-sectional study in a community health Centre of Nairobi, BMC Psychiatry, 2018 18:136 https://doi.org/10.1186/s12888-018-1706-y). An engagement interview approach (Social Work 52(4):295-308, 2007) was applied to elicit various practical, psychological, interpersonal, and cultural barriers to life adjustment, service access, obtaining resources, and psychosocial support related to pregnancy. Grounded theory method was applied for qualitative data sifting and analysis (Strauss and Corbin, Basics of qualitative research, 1990). RESULTS: Findings revealed that pregnant adolescents face four major areas of challenges, including depression, anxiety and stress around the pregnancy, denial of the pregnancy, lack of basic needs provisions and care, and restricted educational or livelihood opportunities for personal development post pregnancy. These challenges were related both to existing social and cultural values/norms on gender and traditional family structure, as well as to service structural barriers (including prenatal care, mental health care, newborn care, parenting support services). More importantly, dealing with these challenges has led to negative mental health consequences in adolescent pregnant girls, including feeling insecure about the future, feeling very defeated and sad to be pregnant, and feeling unsupported and disempowered in providing care for the baby. CONCLUSIONS: Findings have implications for service planning, including developing more integrated mental health services for pregnant adolescents. Additionally, we felt a need for developing reproductive education and information dissemination strategies to improve community members' knowledge of pregnant adolescent mental health issues.

Incremental Benefit-Cost of MOMCare: Collaborative Care for Perinatal Depression Among Economically Disadvantaged Women.

OBJECTIVE: Effectiveness of collaborative care for perinatal depression has been demonstrated for MOMCare, from early pregnancy up to 15 months postpartum, for Medicaid enrollees in a public health system. MOMCare had a greater impact on reducing depression and improving functioning for women with comorbid posttraumatic stress disorder (PTSD) than for those without PTSD. This study estimated the incremental benefit and cost and the net benefit of MOMCare for women with major depression and PTSD. METHODS: A randomized trial (September 2009 to December 2014) compared the MOMCare collaborative care depression intervention (choice of brief interpersonal psychotherapy or pharmacotherapy or both) with enhanced maternity support services (MSS-Plus) in the public health system of Seattle-King County. Among pregnant women with a probable diagnosis of major depression or dysthymia (N=164), two-thirds (N=106) met criteria for probable PTSD. Blinded assessments at three, six, 12, and 18 months postbaseline included the Symptom Checklist-20 depression scale and the Cornell Services Index. Analyses of covariance estimated gain in depression free days (DFDs) by intervention and PTSD status. RESULTS: When the analysis controlled for baseline depression severity, women with probable depression and PTSD in MOMCare had 68 more depression-free days over 18 months than those in MSS-Plus (p<.05). The additional depression care cost per MOMCare participant with comorbid PTSD was $1,312. The incremental net benefit of MOMCare was positive if a DFD was valued at ≥$20. CONCLUSIONS: For women with probable major depression and PTSD, MOMCare had significant clinical benefit over MSS-Plus, with only a moderate increase in health services cost.

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment.

We assessed dimensions of feasibility of a patient navigation system in the Head Start preschool setting to help low-income mothers with depression engage with mental health care. Forty-seven mothers participated; none refused. Navigators demonstrated excellent model fidelity; we experienced no adverse events. We discuss implications for future evaluation design.

Collaborative Care for Perinatal Depression Among Socioeconomically Disadvantaged Women: Adverse Neonatal Birth Events and Treatment Response.

OBJECTIVE: The study examined the effectiveness of a perinatal collaborative care intervention in moderating the effects of adverse neonatal birth events on risks of postpartum depressive symptoms and impaired functioning among women of lower socioeconomic status with antenatal depression. METHODS: A randomized controlled trial with blinded outcome assessments was conducted in ten public health centers, comparing MOMCare (choice of brief interpersonal psychotherapy, pharmacotherapy, or both) with intensive maternity support services (MSS-Plus). Participants had probable diagnoses of major depressive disorder or dysthymia during pregnancy. Generalized estimating equations estimated differences in depression and functioning measures between groups with and without adverse birth events within the treatment arms. A total of 160 women, 43% of whom experienced at least one adverse birth event, were included in the analyses. RESULTS: For women who received MOMCare, postpartum depression scores (measured with the Symptom Checklist-20) did not differ by whether or not they experienced an adverse birth event (mean±SD scores of .86±.51 for mothers with an adverse birth event and .83±.56 for mothers with no event; p=.78). For women who received MSS-Plus, having an adverse birth event was associated with persisting depression in the postpartum period (mean scores of 1.20±.0.61 for mothers with an adverse birth event and .93±.52 for mothers without adverse birth event; p=.04). Similar results were seen for depression response rates and functioning. CONCLUSIONS: MOMCare mitigated the risk of postpartum depressive symptoms and impaired functioning among women of low socioeconomic status who had antenatal depression and who experienced adverse birth events.

Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases.

Including target populations in the design and implementation of research trials has been one response to the growing health disparities endemic to our health care system, as well as an aid to study generalizability. One type of community-based participatory research is "Patient Centered-Research", in which patient perspectives on the germane research questions and methodologies are incorporated into the study. The Patient-Centered Outcomes Research Institute (PCORI) has mandated that meaningful patient and stakeholder engagement be incorporated into all applications. As of March 2015, PCORI funded seven clinically-focused studies of patients with kidney disease. The goal of this paper is to synthesize the experiences of these studies to gain an understanding of how meaningful patient and stakeholder engagement can occur in clinical research of kidney diseases, and what the key barriers are to its implementation. Our collective experience suggests that successful implementation of a patient- and stakeholder-engaged research paradigm involves: (1) defining the roles and process for the incorporation of input; (2) identifying the particular patients and other stakeholders; (3) engaging patients and other stakeholders so they appreciate the value of their own participation and have personal investment in the research process; and (4) overcoming barriers and challenges that arise and threaten the productivity of the collaboration. It is our hope that the experiences of these studies will further interest and capacity for incorporating patient and stakeholder perspectives in research of kidney diseases.

Patient Navigation for Mothers with Depression who Have Children in Head Start: A Pilot Study.

This study assesses the potential of social work-facilitated patient navigation to help mothers with depression engage with mental health care. We conducted a randomized pilot trial (N = 47) in Head Start-a U.S. preschool program for low-income children. Seven lay navigators received training and supervision from professional social workers. After 6 months, more navigated participants engaged with a psychologist, therapist, or social worker (45% vs. 13%, 95% confidence interval [CI] [2, 57]); engaged with any provider, (55% vs. 26%, 95% CI [1, 56]); and reported having a "depression care provider" (80% vs. 41%, 95% CI [9, 65]). Community-based navigation appears feasible; however, more definitive testing is necessary.

A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder.

OBJECTIVE: The comorbidity of posttraumatic stress disorder (PTSD) with antenatal depression poses increased risks for postpartum depression and may delay or diminish response to evidence-based depression care. In a secondary analysis of an 18-month study of collaborative care for perinatal depression, the authors hypothesized that pregnant, depressed, socioeconomically disadvantaged women with comorbid PTSD would show more improvement in the MOMCare intervention providing Brief Interpersonal Psychotherapy and/or antidepressants, compared to intensive public health Maternity Support Services (MSS-Plus). METHODS: A multisite randomized controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System, July 2009-January 2014. Pregnant women were recruited who met criteria for a probable diagnosis of major depressive disorder (MDD) on the Patient Health Questionnaire-9 and/or dysthymia on the MINI-International Neuropsychiatric Interview (5.0.0). The primary outcome was depression severity at 3-, 6-, 12-and 18-month follow-ups; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care. RESULTS: Sixty-five percent of the sample of 164 met criteria for probable comorbid PTSD. The treatment effect was significantly associated with PTSD status in a group-by-PTSD severity interaction, controlling for baseline depression severity (Wald χ²1 = 4.52, P = .03). Over the 18-month follow-up, those with comorbid PTSD in MOMCare (n = 48), versus MSS-Plus (n = 58), showed greater improvement in depression severity (Wald χ²1 = 8.51, P < .004), PTSD severity (Wald χ²1 = 5.55, P < .02), and functioning (Wald χ²1 = 4.40, P < .04); higher rates of depression response (Wald χ²1 = 4.13, P < .04) and remission (Wald χ²1 = 5.17, P < .02); and increased use of mental health services (Wald χ²1 = 39.87, P < .0001) and antidepressant medication (Wald χ²1 = 8.07, P < .005). Participants without comorbid PTSD in MOMCare (n = 33) and MSS-Plus (n = 25) showed equivalent improvement on these outcomes. CONCLUSIONS: Collaborative depression care had a greater impact on perinatal depressive outcomes for socioeconomically disadvantaged women with comorbid PTSD than for those without PTSD. Findings suggest that a stepped care treatment model for high-risk pregnant women with both MDD and PTSD could be integrated into public health systems in the United States. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01045655.

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes.

COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL.

BACKGROUND: Both antenatal and postpartum depression have adverse, lasting effects on maternal and child well-being. Socioeconomically disadvantaged women are at increased risk for perinatal depression and have experienced difficulty accessing evidence-based depression care. The authors evaluated whether "MOMCare,"a culturally relevant, collaborative care intervention, providing a choice of brief interpersonal psychotherapy and/or antidepressants, is associated with improved quality of care and depressive outcomes compared to intensive public health Maternity Support Services (MSS-Plus). METHODS: A randomized multisite controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System. From January 2010 to July 2012, pregnant women were recruited who met criteria for probable major depression and/or dysthymia, English-speaking, had telephone access, and ≥18 years old. The primary outcome was depression severity at 3-, 6-, 12-, 18-month postbaseline assessments; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care. RESULTS: All participants were on Medicaid and 27 years old on average; 58% were non-White; 71% were unmarried; and 65% had probable PTSD. From before birth to 18 months postbaseline, MOMCare (n = 83) compared to MSS-Plus participants (n = 85) attained significantly lower levels of depression severity (Wald's χ(2) = 6.09, df = 1, P = .01) and PTSD severity (Wald's χ(2) = 4.61, df = 1, P = .04), higher rates of depression remission (Wald's χ(2) = 3.67, df = 1, P = .05), and had a greater likelihood of receiving ≥4 mental health visits (Wald's χ(2) = 58.23, df = 1, P < .0001) and of adhering to antidepressants in the prior month (Wald's χ(2) = 10.00, df = 1, P < .01). CONCLUSION: Compared to MSS-Plus, MOMCare showed significant improvement in quality of care, depression severity, and remission rates from before birth to 18 months postbaseline for socioeconomically disadvantaged women. Findings suggest that evidence-based perinatal depression care can be integrated into the services of a county public health system in the United States. CLINICAL TRIAL REGISTRATION: ClinicalTrials.govNCT01045655.

Early pregnancy maternal vitamin D concentrations and risk of gestational diabetes mellitus.

BACKGROUND: While associations of vitamin D deficiency with type 2 diabetes have been well demonstrated, investigations of vitamin D and risk of gestational diabetes mellitus (GDM) reported inconsistent findings. We examined associations of vitamin D status with GDM. METHODS: In a nested case-cohort study (135 GDM cases and 517 non-GDM controls), we measured maternal serum vitamin D status (total 25[OH]D and 25[OH]D3 ) in early pregnancy (16 weeks on average) using liquid chromatography-tandem mass spectroscopy. GDM was diagnosed according to the American Diabetes Association guidelines. We calculated adjusted odds ratios and 95% confidence intervals (CIs) using logistic regression models. RESULTS: GDM cases had lower mean total 25[OH]D (27.3 vs. 29.3 ng/mL) and 25[OH]D3 (23.9 vs. 26.7 ng/mL) concentrations compared with women who did not develop GDM (both P-values < 0.05). Overall, 25[OH]D3 concentrations, but not total 25[OH]D concentrations, were significantly associated with GDM risk. A 5-ng/mL increase in 25[OH]D3 concentration was associated with a 14% decrease in GDM risk (P-value = 0.02). Women in the lowest quartile for 25[OH]D3 concentration had a twofold [95% CI 1.15, 3.58] higher risk of GDM compared with women in the highest quartile (P-value for trend < 0.05). CONCLUSIONS: Early pregnancy vitamin D status, particularly 25[OH]D3 , is inversely associated with GDM risk.

Culturally relevant treatment services for perinatal depression in socio-economically disadvantaged women: the design of the MOMCare study.

BACKGROUND: Depression during pregnancy has been demonstrated to be predictive of low birthweight, prematurity, and postpartum depression. These adverse outcomes potentially have lasting effects on maternal and child well-being. Socio-economically disadvantaged women are twice as likely as middle-class women to meet diagnostic criteria for antenatal major depression (MDD), but have proven difficult to engage and retain in treatment. Collaborative care treatment models for depression have not been evaluated for racially/ethnically diverse, pregnant women on Medicaid receiving care in a public health system. This paper describes the design, methodology, culturally relevant enhancements, and implementation of a randomized controlled trial of depression care management compared to public health Maternity Support Services (MSS). METHODS: Pregnant, public health patients, >18 years with a likely diagnosis of MDD or dysthymia, measured respectively by the Patient Health Questionnaire-9 (PHQ-9) or the Mini-International Neuropsychiatric Interview (MINI), were randomized to the intervention or to public health MSS. The primary outcome was reduction in depression severity from baseline during pregnancy to 18-months post-baseline (one-year postpartum). BASELINE RESULTS: 168 women with likely MDD (96.4%) and/or dysthymia (24.4%) were randomized. Average age was 27.6 years and gestational age was 22.4 weeks; 58.3% racial/ethnic minority; 71.4% unmarried; 22% no high school degree/GED; 65.3% unemployed; 42.1% making <$10,000 annually; 80.4% having recurrent depression; 64.6% PTSD, and 72% unplanned pregnancy. CONCLUSIONS: A collaborative care team, including a psychiatrist, psychologist, project manager, and 3 social workers, met weekly, collaborated with the patients' obstetrics providers, and monitored depression severity using an electronic tracking system. Potential sustainability of the intervention within a public health system requires further study.