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.

Journal: Contemporary clinical trials

Volume: 140

Issue: 

Year of Publication: 

Affiliated Institutions:  Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Electronic address: kristin.ginsberg@auckland.ac.nz. Department of Paediatrics: Child and Youth Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Liggins Institute, University of Auckland, Auckland, New Zealand. Department of Epidemiology and Biostatistics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Department of Psychology and Neuroscience, Auckland University of Technology, Auckland, New Zealand. Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.

Abstract summary 

Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education. Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group.In a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge.This study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population.This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).

Authors & Co-authors:  Ginsberg Alsweiler Rogers Cavadino Douglas Serlachius

Study Outcome 

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Statistics
Citations : 
Authors :  6
Identifiers
Doi : 10.1016/j.cct.2024.107519
SSN : 1559-2030
Study Population
Male,Female
Mesh Terms
Other Terms
Acceptance and Commitment therapy;Anxiety;Depression;Digital mental health interventions;NICU parents;Preterm babies;RCT protocol;Stress
Study Design
Study Approach
Country of Study
Publication Country
United States