IMAGINE: pilot trial of a digital group intervention to prevent perinatal depression

PROJECT SUMMARY/ABSTRACT An estimated 13% of pregnant individuals in the US experience depression perinatally (in pregnancy and/or up to 1 year postpartum), making depression one of the largest contributors to maternal morbidity. Perinatal depression is associated with adverse effects for both the perinatal person and their child. Risk of perinatal depression is inequitably distributed, disproportionately impacting low-income, racial minority individuals and those who have had adverse life experiences. The US Preventive Services Task Force (USPSTF) recently endorsed counseling interventions as moderately effective at preventing perinatal depression and recommended referral of all at-risk individuals to cognitive behavioral therapy (CBT) or interpersonal therapy. However, there remain significant barriers to accessing facility-based interventions for at-risk individuals, including lack of financial resources, time, transportation, or social support to attend in-person services. These barriers may be especially heightened in those individuals at highest risk of perinatal depression. Some access barriers may be overcome by using mobile technology to deliver evidence-based interventions remotely. We previously developed and pilot-tested a digital group adaptation of the evidence-based CBT intervention, the Mothers and Babies course. This digital intervention, named IMAGINE, was developed based on formative input from perinatal individuals and their healthcare providers. IMAGINE is a manualized 10- to 12-week intervention delivered to groups of 6-10 individuals, using asynchronous, interactive, multimedia messaging and an optional weekly synchronous group video call. IMAGINE’s strengths include its fidelity to an evidence-based intervention and inclusion of facilitator guidance and peer support to maximize efficacy. In this pilot effectiveness trial application, we propose to engage a broad range of stakeholders including perinatal individuals at risk of perinatal depression as well as service providers, administrators and payers to complete the following specific aims. In Aim 1 we will use a human-centered design approach to refine IMAGINE and prepare for its delivery as part of routine perinatal mental health services. We will then conduct a pilot randomized trial to (Aim 2) obtain preliminary data on IMAGINE’s engagement of CBT mechanistic targets and effectiveness in preventing perinatal depression, and (Aim 3) obtain preliminary data on implementation outcomes (acceptability, appropriateness, usability, feasibility) and their drivers. This proposal addresses an urgent need to improve access to evidence-based interventions to prevent perinatal depression among those at highest risk. Completion of these aims will generate preliminary data, study tools, and a participatory group of stakeholder advisers to enable pragmatic evaluation of IMAGINE’s impact on perinatal mental health in a future R01.