{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:43:42Z","timestamp":1785545022011,"version":"3.56.0"},"reference-count":39,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Ment Health"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to evaluate the effectiveness of a self-guided digital acceptance and commitment therapy (ACT)\u2013based intervention combined with NICU-specific education (NICU parent acceptance and commitment therapy [NPACT]). The study explored the intervention\u2019s effects on stress among parents and primary caregivers of very preterm infants, compared to a digital education-only intervention, and active control.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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\u2019 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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 \u22120.39 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/92021","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T20:52:36Z","timestamp":1784839956000},"page":"e92021-e92021","source":"Crossref","is-referenced-by-count":0,"title":["A Digital Acceptance and Commitment Therapy and Education Intervention for Caregivers of Very Preterm Infants in the Neonatal Intensive Care Unit: Randomized Controlled Trial"],"prefix":"10.2196","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0636-3676","authenticated-orcid":false,"given":"Kristin Harrison","family":"Ginsberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0874-6654","authenticated-orcid":false,"given":"Jane","family":"Alsweiler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7275-4387","authenticated-orcid":false,"given":"Jenny","family":"Rogers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5709-367X","authenticated-orcid":false,"given":"Alana","family":"Cavadino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1433-0461","authenticated-orcid":false,"given":"Meihana","family":"Douglas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4797-8351","authenticated-orcid":false,"given":"Anna","family":"Serlachius","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,7,23]]},"reference":[{"issue":"2","key":"R1","doi-asserted-by":"publisher","first-page":"104","DOI":"10.3345\/cep.2023.00486","article-title":"Prevalence of anxiety, depression, and stress among parents of neonates admitted to neonatal intensive care unit: a systematic review and meta-analysis","volume":"67","author":"Shetty","journal-title":"Clin Exp Pediatr"},{"issue":"3","key":"R2","doi-asserted-by":"publisher","first-page":"230","DOI":"10.1007\/s10880-010-9202-7","article-title":"Prevalence and correlates of posttraumatic stress and postpartum depression in parents of infants in the Neonatal Intensive Care Unit (NICU)","volume":"17","author":"Lefkowitz","journal-title":"J Clin Psychol Med Settings"},{"issue":"10","key":"R3","doi-asserted-by":"publisher","DOI":"10.3390\/children12101311","article-title":"The impact of preterm birth on parents\u2019 mental health and the role of family-centred interventions: a narrative review","volume":"12","author":"C\u00eempian","journal-title":"Children (Basel)"},{"issue":"1","key":"R4","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1016\/j.ajog.2016.01.004","article-title":"Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort","volume":"215","author":"Manuck","journal-title":"Am J Obstet Gynecol"},{"issue":"5","key":"R5","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1016\/j.jogn.2020.05.007","article-title":"Effect of fathers\u2019 presence and involvement in newborn care in the NICU on mothers\u2019 symptoms of postpartum depression","volume":"49","author":"Kim","journal-title":"J Obstet Gynecol Neonatal Nurs"},{"issue":"3","key":"R6","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2016-1870","article-title":"NICU-based interventions to reduce maternal depressive and anxiety symptoms: a meta-analysis","volume":"139","author":"Mendelson","journal-title":"Pediatrics"},{"issue":"3","key":"R7","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1038\/s41372-018-0310-9","article-title":"Reducing parental trauma and stress in neonatal intensive care: systematic review and meta-analysis of hospital interventions","volume":"39","author":"Sabnis","journal-title":"J Perinatol"},{"key":"R8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2023.113456","article-title":"Psychosocial support provided to parents of infants in neonatal intensive care units: an international survey","volume":"259","author":"Ginsberg","journal-title":"J Pediatr"},{"issue":"6","key":"R9","doi-asserted-by":"publisher","DOI":"10.3390\/children9060793","article-title":"National cross-sectional study of mental health screening practices for primary caregivers of NICU infants","volume":"9","author":"Bloyd","journal-title":"Children (Basel)"},{"issue":"5","key":"R10","doi-asserted-by":"publisher","DOI":"10.2196\/35159","article-title":"Digital health interventions for delivery of mental health care: systematic and comprehensive meta-review","volume":"9","author":"Philippe","journal-title":"JMIR Ment Health"},{"issue":"4","key":"R11","doi-asserted-by":"publisher","first-page":"133","DOI":"10.5498\/wjp.v11.i4.133","article-title":"Effectiveness of digital psychotherapeutic intervention among perinatal women: A systematic review and meta-analysis of randomized controlled trials","volume":"11","author":"Lau","journal-title":"World J Psychiatry"},{"issue":"2","key":"R12","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1080\/17437199.2023.2185654","article-title":"Effects of digital health interventions on the psychological outcomes of perinatal women: umbrella review of systematic reviews and meta-analyses","volume":"18","author":"Lau","journal-title":"Health Psychol Rev"},{"key":"R13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcbs.2024.100809","article-title":"Acceptance and commitment therapy: what the history of ACT and the first 1,000 randomized controlled trials reveal","volume":"33","author":"Hayes","journal-title":"J Contextual Behav Sci"},{"issue":"1","key":"R14","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.brat.2005.06.006","article-title":"Acceptance and commitment therapy: model, processes and outcomes","volume":"44","author":"Hayes","journal-title":"Behav Res Ther"},{"key":"R15","doi-asserted-by":"publisher","DOI":"10.1016\/j.comppsych.2023.152426","article-title":"Effectiveness of acceptance and commitment therapy-based interventions for improving the psychological health of parents of children with special health care needs: a systematic review and meta-analysis","volume":"127","author":"Li","journal-title":"Compr Psychiatry"},{"key":"R16","doi-asserted-by":"publisher","DOI":"10.1016\/j.invent.2021.100382","article-title":"Supporting parents of children with chronic conditions: a randomized controlled trial of web-based and self-help ACT interventions","volume":"24","author":"Lappalainen","journal-title":"Internet Interv"},{"key":"R17","doi-asserted-by":"publisher","DOI":"10.2196\/66401","article-title":"Exploring stress and stress-reduction with caregivers and clinicians in the neonatal intensive care unit to inform intervention development: qualitative interview study","volume":"8","author":"Ginsberg","journal-title":"JMIR Pediatr Parent"},{"key":"R18","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2024.107519","article-title":"A digital acceptance and commitment therapy and education intervention targeting stress of parents and caregivers with preterm babies in the neonatal intensive care unit: A randomised controlled cluster trial protocol","volume":"140","author":"Ginsberg","journal-title":"Contemp Clin Trials"},{"issue":"sep04 1","key":"R19","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e5661","article-title":"Consort 2010 statement: extension to cluster randomised trials","volume":"345","author":"Campbell","journal-title":"BMJ"},{"key":"R20","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2010.07.040","article-title":"Relevance of CONSORT reporting criteria for research on eHealth interventions","volume":"81 Suppl","author":"Baker","journal-title":"Patient Educ Couns"},{"issue":"3","key":"R21","first-page":"148","volume":"42","author":"Miles","journal-title":"Nurs Res"},{"issue":"4","key":"R22","doi-asserted-by":"crossref","first-page":"385","DOI":"10.2307\/2136404","volume":"24","author":"Cohen","journal-title":"J Health Soc Behav"},{"key":"R23","unstructured":"Spielberger CD Gorsuch RL . Manual Fot the State-Trait Anxiety Inventory (Self Evaluation Questionnaire). Consulting Psychologists Press, Inc; 1970."},{"issue":"3","key":"R24","doi-asserted-by":"publisher","DOI":"10.1177\/014662167700100306","article-title":"The CES-D Scale: a self-report depression scale for research in the general population self-report depression scale for research in the general population","volume":"1","author":"Radloff","journal-title":"Appl Psychol Meas"},{"issue":"4","key":"R25","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1007\/BF03395492","article-title":"Measuring experiential avoidance: a preliminary test of a working model","volume":"54","author":"Hayes","journal-title":"Psychol Rec"},{"issue":"5","key":"R26","doi-asserted-by":"publisher","first-page":"e1414","DOI":"10.1542\/peds.2005-2580","article-title":"Reducing premature infants\u2019 length of stay and improving parents\u2019 mental health outcomes with the creating opportunities for parent empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial","volume":"118","author":"Melnyk","journal-title":"Pediatrics"},{"issue":"5","key":"R27","doi-asserted-by":"publisher","first-page":"555","DOI":"10.1016\/j.eurpsy.2014.12.008","article-title":"Early psychological reactions in parents of children with a life threatening illness within a pediatric hospital setting","volume":"30","author":"Muscara","journal-title":"Eur Psychiatry"},{"issue":"2","key":"R28","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1111\/1541-0420.00049","article-title":"Multiple outputation: inference for complex clustered data by averaging analyses from independent data","volume":"59","author":"Follmann","journal-title":"Biometrics"},{"issue":"4","key":"R29","doi-asserted-by":"publisher","first-page":"1121","DOI":"10.1093\/biomet\/88.4.1121","article-title":"Within-cluster resampling","volume":"88","author":"Hoffman","journal-title":"Biometrika"},{"issue":"2","key":"R30","doi-asserted-by":"publisher","first-page":"202","DOI":"10.1016\/j.jpeds.2009.08.049","article-title":"Accounting for multiple births in neonatal and perinatal trials: systematic review and case study","volume":"156","author":"Hibbs","journal-title":"J Pediatr"},{"issue":"9","key":"R31","doi-asserted-by":"publisher","first-page":"1277","DOI":"10.1177\/1049732305276687","article-title":"Three approaches to qualitative content analysis","volume":"15","author":"Hsieh","journal-title":"Qual Health Res"},{"key":"R32","doi-asserted-by":"publisher","DOI":"10.2196\/62761","article-title":"Exploring participants\u2019 experiences of digital health interventions with qualitative methods: guidance for researchers","volume":"26","author":"Harrison Ginsberg","journal-title":"J Med Internet Res"},{"issue":"19-20","key":"R33","doi-asserted-by":"publisher","first-page":"2745","DOI":"10.1111\/jocn.13259","article-title":"Systematic review of qualitative studies exploring parental experiences in the neonatal intensive care unit","volume":"25","author":"Al Maghaireh","journal-title":"J Clin Nurs"},{"issue":"2","key":"R34","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1089\/bfm.2022.0151","article-title":"Neonatal intensive care unit interventions to improve breastfeeding rates at discharge among preterm and low birth weight infants: a systematic review and meta-analysis","volume":"18","author":"Song","journal-title":"Breastfeed Med"},{"issue":"2","key":"R35","doi-asserted-by":"publisher","first-page":"387","DOI":"10.1007\/s10880-022-09902-8","article-title":"Mindfulness and relaxation-based interventions to reduce parental stress, anxiety and\/or depressive symptoms in the neonatal intensive care unit: a systematic review","volume":"30","author":"Ginsberg","journal-title":"J Clin Psychol Med Settings"},{"issue":"5","key":"R36","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2021-054272","article-title":"Promoting human milk and breastfeeding for the very low birth weight infant","volume":"148","author":"Parker","journal-title":"Pediatrics"},{"issue":"1","key":"R37","doi-asserted-by":"publisher","DOI":"10.1186\/s12887-024-04596-3","article-title":"The association between sex and neonatal respiratory distress syndrome","volume":"24","author":"Fang","journal-title":"BMC Pediatr"},{"issue":"6","key":"R38","doi-asserted-by":"publisher","DOI":"10.2196\/36004","article-title":"The effects of nonclinician guidance on effectiveness and process outcomes in digital mental health interventions: systematic review and meta-analysis","volume":"24","author":"Leung","journal-title":"J Med Internet Res"},{"key":"R39","unstructured":"Human health research services platform. Human Health Research Services Platform, University of Auckland. URL: https:\/\/www.healthresearchplatform.auckland.ac.nz\/ [Accessed 30-06-2026]"}],"container-title":["JMIR Mental Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/mental.jmir.org\/2026\/1\/e92021","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T22:24:01Z","timestamp":1785536641000},"score":1,"resource":{"primary":{"URL":"https:\/\/mental.jmir.org\/2026\/1\/e92021"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,23]]},"references-count":39,"URL":"https:\/\/doi.org\/10.2196\/92021","relation":{},"ISSN":["2368-7959"],"issn-type":[{"value":"2368-7959","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,23]]},"article-number":"v13i2e92021"}}