A Pilot Randomized Controlled Trial of a Multimodal Wellness Intervention for Perinatal Mental Health

Abstract

Introduction

Evidence has shown that pregnant women who report high rates of psychologic stress are at increased risk for perinatal complications. We conducted a pilot randomized controlled trial (RCT) of a multimodal wellness intervention (MWI) composed of motivational interviewing and mental wellness skills to examine feasibility and acceptability of MWI and to compare changes in subjective measures of psychological and socioemotional outcomes among pregnant women through early postpartum.

Methods

Between March 2023 and February 2024, eligible pregnant individuals aged 18 and older, at 10 to 24 weeks’ gestation, and English-speaking were recruited from a university-affiliated federally qualified health center (FQHC) in a large metropolitan area. Forty participants were randomized 1:1 to 4 weekly individual (45-60 minutes) virtual sessions of MWI or prenatal education control. Patient-reported perinatal distress and wellness indicators were interview-administered at baseline, postintervention, 2 months postintervention, and 6 weeks postpartum. This study was registered at ClinicalTrials.gov (NCT05718479).

Results

The mean (SD) age of participants was 27.9 (5.7) years. Most participants identified as Black or African American (70%) pregnant women, with three-quarters being seen for prenatal services at an FQHC. The mean (SD) number of completed intervention sessions was 3.3 (1.3), with 75% of participants completing all 4 sessions. All participants reported being satisfied with the intervention, with 73% who were very satisfied and 86.7% who found the program very useful. MWI versus prenatal education demonstrated medium- to large-sized effects on reducing anxiety from mild to minimal symptoms and resulted in significantly increased health-promoting behaviors (eg, exercise, sleep, nutrition) at follow-up timepoints.

Discussion

Findings suggest that MWI was feasible and acceptable, in addition to demonstrating larger reductions in anxiety and greater increases in health-promoting behaviors compared to prenatal education among pregnant women. Further exploration of efficacy outcomes would require a larger sample size to detect more precise effects of MWI on psychological and socioemotional functioning during the perinatal period.