Protocol for an economic evaluation of scalable strategies to improve mental health among perinatal women: non-specialist care delivered via telemedicine vs. specialist care delivered in-person.

BACKGROUND: Perinatal depression affects an estimated 1 in 5 women in North America during the perinatal period, with annualized lifetime costs estimated at $20.6 billion CAD in Canada and over $45.9 billion USD in the US. Access to psychological treatments remains limited for most perinatal women suffering from depression and anxiety. Some barriers to effective care can be addressed through task-sharing to non-specialist providers and through telemedicine platforms. The cost-effectiveness of these strategies compared to traditional specialist and in-person models remains unknown. This protocol describes an economic evaluation of non-specialist providers and telemedicine, in comparison to specialist providers and in-person sessions within the ongoing Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial. METHODS: The economic evaluation will be undertaken alongside the SUMMIT trial. SUMMIT is a pragmatic, randomized, non-inferiority trial across five North American study sites (N = 1,226) of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a behavioural activation treatment for perinatal depressive and anxiety symptoms. The primary economic evaluation will be a cost-utility analysis. The outcome will be the incremental cost-effectiveness ratio, which will be expressed as the additional cost required to achieve an additional quality-adjusted life-year, as assessed by the EuroQol 5-Dimension 5-Level instrument. A secondary cost-effectiveness analysis will use participants' depressive symptom scores. A micro-costing analysis will be conducted to estimate the resources/costs required to implement and sustain the interventions; healthcare resource utilization will be captured via self-report. Data will be pooled and analysed using uniform price and utility weights to determine cost-utility across all trial sites. Secondary country-specific cost-utility and cost-effectiveness analyses will also be completed. Sensitivity analyses will be conducted, and cost-effectiveness acceptability-curves will be generated, in all instances. DISCUSSION: Results of this study are expected to inform key decisions related to dissemination and scale up of evidence-based psychological interventions in Canada, the US, and possibly worldwide. There is potential impact on real-world practice by informing decision makers of the long-term savings to the larger healthcare setting in services to support perinatal women with common mental health conditions.

Scaling up quality-assured psychotherapy: The role of therapist competence on perinatal depression and anxiety outcomes.

OBJECTIVES: To examine: (1) the psychometric properties of two therapist competence measures-multiple choice questionnaire (MCQ) and standardized role-plays; (2) whether therapist competence differed between non-specialist (NSPs) and specialist (SPs) providers; and (3) the relations between therapist competence and patient outcomes among perinatal patients receiving brief psychotherapy. METHODS: This study is embedded within the SUMMIT Trial-a large, ongoing psychotherapy trial for perinatal women with depressive and anxiety symptoms. We assessed the: (1) psychometric properties of therapist competence measures using Cronbach's alpha and inter-class correlation; (2) differences in therapist competence scores between n = 23 NSPs and n = 22 SPs using a two-sample t-test; and (3) relations between therapist competence measures and perinatal patient outcomes through a linear regression model. RESULTS: Internal consistency for role-play was acceptable (α = 0.71), whereas MCQ was excellent (α = 0.97). Role-play showed good inter-rater reliability (ICC = 0.80) and scores were higher for SPs compared with NSPs (t(2,38) = -2.86, p = 0.0069) and associated with outcomes of anxiety (B = 1.52, SE = 0.60, p = 0.01) and depressive (B = 0.96, SE = 0.55, p = 0.08) symptom scores. CONCLUSIONS: Our study highlights the importance of demonstrating psychological treatment skills through standardized role-plays over knowledge-based competence to predict perinatal patient outcomes. Using well-defined evidence-based tools is critical for deploying NSPs to provide high-quality psychotherapy and increase accessibility to psychological treatments for perinatal populations worldwide.

Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study.

BACKGROUND: Depression is one of the most common complications of childbirth, and is experienced by approximately 17% of pregnant women and 13% of postpartum women. An estimated 85% of these women go untreated-an alarming statistic given the serious consequences for the mother, her child, other family members, and society. Professional societies (the American College of Obstetricians and Gynecologists and American Academy of Pediatrics) have recommended improvements in screening and treatment. Meta-analyses indicate that cognitive behavioral therapy eHealth interventions are efficacious for depression, generally, and for perinatal depression, specifically. Earlier controlled trials have established the effectiveness and acceptability of MomMoodBooster (including an Australian version, MumMoodBooster), an eHealth program for ameliorating postpartum depression. OBJECTIVE: This study aimed to evaluate the effectiveness of a perinatal version of MomMoodBooster encompassing both prenatal and postpartum content in a healthcare delivery setting already providing universal screening and referral of at-risk patients as part of routine care. STUDY DESIGN: A practical effectiveness study randomly assigned 95 pregnant and 96 postpartum women screened as depressed and satisfying eligibility criteria to experimental groups: the healthcare organization's perinatal depression care program (routine-care group) and routine care+MomMoodBooster2 program (eHealth group). Eligibility criteria included: pregnant or <1 year postpartum, ≥18 years of age, no active suicidal ideation, access to broadband internet via desktop/laptop, tablet, or smartphone, and English language proficiency. RESULTS: Intent-to-treat analyses of group effects used fixed-effects growth models to assess 12-week posttest change in outcomes. Results showed that both groups had significantly decreased depression severity, anxiety, stress, and automatic thoughts, and increased behavioral activation and self-efficacy. Relative to the routine-care group, the eHealth group displayed significantly greater decreases in depression severity and stress. These group comparisons were not moderated by depression severity (screening or baseline), anxiety, stress, or pregnant/postpartum status. Almost all (93%; n=89) women in the eHealth group visited their program, of whom 99% visited program sessions (M sessions visited=4.3±2.0; M total session duration=73.0±70.2 minutes; 49% viewed all 6 sessions). Among confirmed eHealth program users who provided ratings, 96% (79/82) rated their program as easy to use, 83% rated it helpful, and 93% (76/82) indicated that they would recommend it. CONCLUSION: Results support the effectiveness of using MomMoodBooster2 as a treatment option for perinatal women with depression, especially when combined with universal depression screening and referral. Consequently, the eHealth program shows promise as a tool to increase the reach of treatment delivery and to potentially reduce the number of untreated perinatal women with depression.

Associations Between Maternal Depression, Antidepressant Use During Pregnancy, and Adverse Pregnancy Outcomes: An Individual Participant Data Meta-analysis.

OBJECTIVE: To evaluate the associations of depressive symptoms and antidepressant use during pregnancy with the risks of preterm birth, low birth weight, small for gestational age (SGA), and low Apgar scores. DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov, and PsycINFO up to June 2016. METHODS OF STUDY SELECTION: Data were sought from studies examining associations of depression, depressive symptoms, or use of antidepressants during pregnancy with gestational age, birth weight, SGA, or Apgar scores. Authors shared the raw data of their studies for incorporation into this individual participant data meta-analysis. TABULATION, INTEGRATION, AND RESULTS: We performed one-stage random-effects meta-analyses to estimate odds ratios (ORs) with 95% CIs. The 215 eligible articles resulted in 402,375 women derived from 27 study databases. Increased risks were observed for preterm birth among women with a clinical diagnosis of depression during pregnancy irrespective of antidepressant use (OR 1.6, 95% CI 1.2-2.1) and among women with depression who did not use antidepressants (OR 2.2, 95% CI 1.7-3.0), as well as for low Apgar scores in the former (OR 1.5, 95% CI 1.3-1.7), but not the latter group. Selective serotonin reuptake inhibitor (SSRI) use was associated with preterm birth among women who used antidepressants with or without restriction to women with depressive symptoms or a diagnosis of depression (OR 1.6, 95% CI 1.0-2.5 and OR 1.9, 95% CI 1.2-2.8, respectively), as well as with low Apgar scores among women in the latter group (OR 1.7, 95% CI 1.1-2.8). CONCLUSION: Depressive symptoms or a clinical diagnosis of depression during pregnancy are associated with preterm birth and low Apgar scores, even without exposure to antidepressants. However, SSRIs may be independently associated with preterm birth and low Apgar scores. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42016035711.

Feasibility of perinatal mood screening and text messaging on patients' personal smartphones.

Screens and adjunctive treatments for perinatal mood are available, but barriers prevent many women from receiving them. Mobile technology may help bypass barriers. The purpose of this study was to evaluate the feasibility of screening and texting perinatal women via their personal smartphones. This prospective cohort study enrolled 203 pregnant and postpartum women receiving obstetric care at a Midwestern US academic medical center. Participants received one electronic mood screen and three text messages per week for two weeks. Texts were based on the Mothers and Babies Course, a CBT-based preventative program that addresses limited social support, lack of pleasant activities, and harmful thought patterns. Feasibility was defined as the ability to take the mood screen and receive texts without technical difficulties. Demographic variables were paired with results. Insurance type (private or public) was used as a proxy for socioeconomic status. Pearson chi-squared tests were used to analyze the data. A text-based satisfaction survey was also administered. The sample was 72% privately insured and 28% publicly insured. Sixty-seven percent completed electronic screening. Screen completion was significantly associated with private insurance (OR = 3.8, 95% CI 2.00-7.30) and "married" status (OR = 1.93, 95% CI 1.01-3.70). Most survey respondents (92%) found it easy to receive the texts, and 76% responded with very favorable comments about the texts. Smartphone mood screening and supportive texting were technically feasible. Screen completion was lower among single women with public insurance.

The experience of depression, anxiety, and mania among perinatal women.

We assessed differential item functioning (DIF) based on computerized adaptive testing (CAT) to examine how perinatal mood disorders differ from adult psychiatric disorders. The CAT-Mental Health (CAT-MH) was administered to 1614 adult psychiatric outpatients and 419 perinatal women with IRB approval. We examined individual item-level differences using logistic regression and overall score differences by scoring the perinatal data using the original bifactor model calibration based on the psychiatric sample data and a new bifactor model calibration based on the perinatal data and computing their correlation. To examine convergent validity, we computed correlations of the CAT-MH with contemporaneously administered Edinburgh Postnatal Depression Scales (EPDS). The rate of major depression in the perinatal sample was 13 %. Rates of anxiety, mania, and suicide risk were 5, 6, and 0.4 %, respectively. One of 66 depression items, one of 69 anxiety items, and 15 of 53 mania items exhibited DIF (i.e., failure to discriminate between high and low levels of the disorder) in the perinatal sample based on the psychiatric sample calibration. Removal of these items resulted in correlations of the original and perinatal calibrations of r = 0.983 for depression, r = 0.986 for anxiety, and r = 0.932 for mania. The 91.3 % of cases were concordantly categorized as either "at-risk" or "low-risk" between the EPDS and the perinatal calibration of the CAT-MH. There was little evidence of DIF for depression and anxiety symptoms in perinatal women. This was not true for mania. Now calibrated for perinatal women, the CAT-MH can be evaluated for longitudinal symptom monitoring.

Suicide risk among perinatal women who report thoughts of self-harm on depression screens.

OBJECTIVE: To estimate the incidence and clinical significance of suicidal ideation revealed during perinatal depression screening and estimate the associated suicide risk. METHODS: Retrospective cohort study of women completing the Edinburgh Postnatal Depression Scale at 24-28 weeks of gestation and 6 weeks postpartum through a suburban integrated health system with approximately 5,000 annual deliveries on two hospital campuses. Suicidal ideation on the Edinburgh Postnatal Depression Scale and prediction of suicide risk were examined through multivariable modeling and qualitative analysis of clinical assessments. RESULTS: Among 22,118 Edinburgh Postnatal Depression Scale questionnaires studied, suicidal ideation was reported on 842 (3.8%, 95% confidence interval [CI] 3.5-4.1%) and was positively associated with younger maternal age (antepartum mean age 30.9 compared with 31.9 years, P=.001), unpartnered relationship status (antepartum 29.5% compared with 16.5%, P<.001 and postpartum 25.0% compared with 17.5%, P<.01), non-Caucasian race (antepartum 62.1% compared with 43.8%, P<.001 and postpartum 62.4% compared with 45.2%, P<.001), non-English language (antepartum 11.0% compared with 6.6%, P<.001 and postpartum 12.4% compared with 7.7%, P<.01), public insurance (antepartum 19.9% compared with 12.5%, P<.001 and postpartum 18.2% compared with 14.2%, P<.001), and preexisting psychiatric diagnosis (antepartum 8.4% compared with 4.2%, P<.001 and postpartum 12.0% compared with 5.8%, P<.001). Multivariable antepartum and postpartum models retained relationship status, language, relationship status by language interaction, and race; the postpartum model also found planned cesarean delivery negatively associated with suicidal ideation risk (odds ratio [OR] 0.56, 95% CI 0.36-0.87) and severe vaginal laceration positively associated with suicidal ideation risk (OR 2.1, 95% CI 1.00-4.40). A qualitative study of 574 women reporting suicidal ideation indicated that 330 (57.5%, 95% CI 53.5-61.5%) experienced some degree of suicidal thought. Six patients (1.1%, 95% CI 0.2-1.9%) demonstrated active suicidal ideation with plan, intent, and access to means. Within this highest risk group, three patients reported a suicide attempt within the perinatal period. CONCLUSION: Among perinatal women screened for depression, 3.8% reported suicidal ideation, but only 1.1% of this subgroup was at high risk for suicide. These findings support the need for systematic evaluation of those who report suicidal ideation to identify the small subset requiring urgent evaluation and care.

Antenatal depressive symptoms increase the likelihood of preterm birth.

OBJECTIVE: We evaluated the relationship between antenatal depressive symptoms and preterm birth. STUDY DESIGN: Patients completed the Edinburgh Postnatal Depression Scale between 24-28 weeks of gestation. A score ≥ 12 (or thoughts of self-harm) indicated an at-risk woman. Symptomatic women were compared to risk-negative patients for relevant demography, historical variables, and pregnancy outcome. RESULTS: After screening 14,175 women we found a screen positive rate of 9.1% (n = 1298). At-risk women had a significant increase in preterm birth at <37, <34, <32, and <28 weeks of gestation. Multivariable analysis adjusting for maternal age, race/ethnicity, prior preterm delivery, and insurance status revealed a persistent association between antenatal depressive symptoms and preterm birth (adjusted odds ratio, 1.3; 95% confidence interval, 1.09-1.35), which was also observed after multiple gestations were excluded from the analysis (odds ratio, 1.7; 95% confidence interval, 1.38-1.99). CONCLUSION: In this large cohort of prenatally screened women, those with depressive symptoms had an increased likelihood of preterm birth.

The pattern of depression screening results across successive pregnancies.

OBJECTIVE: Determine whether depression screen results are consistent across successive pregnancies. STUDY DESIGN: The Edinburgh Postnatal Depression Scale was administered in 2 successive pregnancies to 2116 women. A woman was "screen-positive" if she scored ≥ 12 at 24-28 weeks' or 6-weeks' postpartum. Screen-positive women were assessed by telephone and triaged by mental health professionals. RESULTS: Most women (87.9%) were screen-negative in both pregnancies; 1.7% screened successively positive, 5.9% screened positive in only the first pregnancy; 4.5% screened positive in only the second pregnancy. Unpartnered, nonwhite, and publicly insured women were each likelier to screen positive in either or both pregnancies (P < .0001). Gestational age at delivery was significantly greater in women who never screened positive (P < .05). A majority (63%) of screen-positive women in both pregnancies reported no history of mood disorder. CONCLUSION: There is sufficient variability in depression screening results between successive gestations to warrant screening during each pregnancy.

Barriers to mental health treatment among obstetric patients at risk for depression.

OBJECTIVE: The objective of the study was to examine mental health referrals outcomes among obstetric patients at risk for depression. STUDY DESIGN: Fifty-one perinatal women who were offered mental health referrals were queried about their behaviors at 4 steps in the treatment engagement process and factors facilitating or impeding each step. RESULTS: Although 59% of at-risk women accepted mental health referrals, only 27% ultimately engaged in treatment. Women who proactively sought help via a hotline were more likely to accept referrals (P < .001), contact a referred provider (P < .001), and engage in treatment (P < .05) than those who received unsolicited referrals after screening at-risk for depression. Barriers to successful treatment linkage were identified at the patient, provider, and system levels. CONCLUSION: Only a minority of women who are at risk for perinatal depression and receive mental health referrals ultimately engage in treatment. Successful linkage may be enhanced via interventions targeting identified barriers; such interventions require prospective evaluation.

Obstetric care provider engagement in a perinatal depression screening program.

To investigate obstetric care provider attitudes toward perinatal depression screening and factors associated with variable screening rates. Provider attitudes about depression screening were investigated via structured interviews (open-ended and rating scale questions) and analyzed using qualitative content analysis. Most providers (86%) found screening effective at identifying women at risk for perinatal depression (average rating of 8.7 on 10-point analog scale). However, 95% overestimated their own screening rates and 67% inaccurately thought they achieved universal screening. Providers not directly involved in their office-based screening process demonstrated lower average screening rates (37%) than those who maintained active involvement (59%; p = 0.07). Obstetric care providers support perinatal depression screening in the context of a program that assumes responsibility for processing screens, conducts assessments of at-risk women and provides referrals to mental health professionals. Provider participation in screening and tying screening to routine obstetric outpatient activities such as glucose tolerance testing are associated with higher screening rates.

The utility of maternal depression screening in the third trimester.

OBJECTIVE: The purpose of this study was to estimate the prevalence of maternal depressive risk in patients during the third trimester and to determine whether unique at-risk women are identified when the data are compared with postpartum screening. STUDY DESIGN: As part of a comprehensive program for universal perinatal depression screening and behavioral health referral of at-risk women, patients completed the Edinburgh Postnatal Depression Scale both during pregnancy (24-28 weeks of gestation) and again at 6 weeks after delivery. Based on Edinburgh Postnatal Depression Scale scores of > or =12, the prevalence of antepartum depressive risk and the rates of concordant/discordant risk status with the corresponding postpartum results were calculated. Discordant-risk cases were further analyzed to determine whether obstetric, psychosocial, or demographic variables were associated with changing risk status over time. RESULTS: We screened 1584 women in the third trimester and again after delivery: 7.7% and 6.8% of the women scored in the at-risk range in the antepartum and postpartum time frames, respectively; 88.9% of patients had the same risk status, and 11.1% were discordant before and after delivery. Statistically significant associations were found between premature birth, newborn infant admission to the intensive care nursery, and acquisition of postpartum depressive risk. CONCLUSION: Screening for depression in the third trimester resulted in a comparable prevalence rate of depressive risk identification when compared with the postpartum time frame. Unique women were identified before and after delivery who may have been missed if screening had not been performed twice.