A Digital Acceptance and Commitment Therapy and Education Intervention for Caregivers of Very Preterm Infants in the Neonatal Intensive Care Unit: Randomized Controlled Trial.

Background: Parents of very preterm infants admitted to the neonatal intensive care unit (NICU) experience high levels of psychological distress, yet access to timely, evidence-based mental health support is limited by staffing and resource constraints. Digital mental health interventions offer a scalable approach to addressing this gap; however, their effectiveness has not been well established in NICU caregiver populations, particularly during periods of acute stress. Objective: This study aims to evaluate the effectiveness of a self-guided digital acceptance and commitment therapy (ACT)-based intervention combined with NICU-specific education (NICU parent acceptance and commitment therapy [NPACT]). The study explored the intervention's effects on stress among parents and primary caregivers of very preterm infants, compared to a digital education-only intervention, and active control. Methods: We conducted a 3-arm, single-center, randomized controlled cluster trial in a tertiary NICU. Parents and primary caregivers of very preterm infants (<32 wk' gestational age,<1 wk old) were randomized by family cluster to (1) NPACT (ACT+ education), (2) a digital education-only intervention, or (3) active control. Digital interventions were delivered via a web-based platform over 2 weeks. The primary outcome was NICU-related stress on the Parent Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) at 2 weeks postrandomization. Secondary outcomes included caregiver anxiety, depression, perceived stress, and selected neonatal outcomes. Engagement and perceived helpfulness were assessed for digital interventions. Results: A total of 102 caregivers from 68 family clusters (79 infants; mean gestational age 28.1, SD 2.2 wk) were enrolled. There were no statistically significant between-group differences in the mean PSS:NICU scores at 2 weeks (NPACT 3.0, SD 0.9; education-only 2.5, SD 1; active control 2.6, SD 0.9; adjusted mean difference for NPACT vs active control 0.04, 95% CI -0.39 to 0.47). No between-group differences were observed for secondary psychological outcomes at any time point. However, caregivers in both digital intervention groups had higher odds of full breastfeeding at discharge compared with active control. Engagement with the digital interventions was high, with 97% (28/29) of NPACT participants and 76% (19/25) of education-only participants completing at least 5 of 7 modules, and both interventions were rated as very helpful. Conclusions: In this trial, an unguided digital mental health intervention delivered during NICU admission did not reduce NICU-specific parental stress or other psychological outcomes relative to active control. However, the intervention was highly used by caregivers. These findings suggest that while a brief digital mental health intervention can be successfully implemented in a high-stress clinical setting with caregivers, its capacity to reduce acute psychological distress may be limited. Secondary findings indicate potential benefits of the digital intervention on breastfeeding, generating hypotheses for future research. Digital mental health interventions in neonatal settings may be most effective when integrated within hybrid models of care and/or delivered beyond the acute admission phase.