Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

Abstract

BackgroundStress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being.Methods/DesignThe purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes.Trial registrationClinicalTrials.gov Identifier: NCT01901796

Sleep duration, vital exhaustion, and odds of spontaneous preterm birth: a case–control study

“…Many pregnant women are affected by sleep deprivation and disorders; thus, this knowledge could significantly improve birth outcomes worldwide [ 7 – 10 ]. There have been multiple intervention studies aimed at improving sleep in pregnancy and the early post-partum period with the goal of decreasing rates of post-partum depression [ 42 – 44 ]. Additionally, Blyton et al [ 45 ] used positive airway pressure to treat sleep disordered breathing during pregnancy and was able to increase the average number of fetal movements in women with preeclampsia from 319 to 592 per night (P <0.0001).…”

Screening for and Treating Postpartum Depression and Psychosis: A Cost-Effectiveness Analysis

“…Further, a review of screening programs found five studies that concluded screening for depression resulted in decreased depressive symptoms and improved mental health, though there is a lack of well-designed randomized control trials in the field overall (Myers et al 2013; Thombs et al 2014). In Canada, a large randomized controlled trial is underway testing prenatal depression screening and online cognitive behavioral therapy via telemedicine technology, and early feasibility studies found that women were very receptive to depression screening and treatment (Kingston et al 2014). The intervention proposed in this paper models physicians providing depression treatment to women under the supervision of a psychiatrist.…”

“…Early data from trials in this area indicate both patients and providers can be receptive to the proposed intervention and the infrastructure needed to carry it out is already generating cost savings in the state (Frayne et al 2015; Kingston et al 2014; Office of Rural Health and Community Care 2014). Prospective research is needed to determine what policies, incentives, and monitoring are needed to increase screening and treatment of PPD and PP, both of which are important health issues for women, children, and families (Kozhimannil et al 2011; Milgrom et al 2011; Palladino et al 2011).…”

Perinatal Depression Among HIV-Infected Women in KwaZulu-Natal South Africa: Prenatal Depression Predicts Lower Rates of Exclusive Breastfeeding

“…Our findings demonstrating a strong link between prenatal depression decreasing a women’s likelihood to EBF at six-weeks, despite infant feeding intentions, highlight the critical need to increase attention on mental health support within prevention of MTCT of HIV programs. Identifying women with even mild prenatal depression is important to achieve better maternal and infant health outcomes [50]. …”