Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

Johns Hopkins University

Status: Completed

Conditions: Depressive Symptoms; Post-traumatic Stress Symptoms; Anxiety

Treatments: Behavioral: Infant Health Education Program; Behavioral: Mindfulness Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03942627

IRB00159072

R34AT009615 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This small randomized pilot study will evaluate feasibility and preliminary outcomes of an audio-delivered mindfulness program to reduce psychological distress for mothers with an infant in neonatal intensive care, as compared with an active control condition.

Full description

An estimated 400,000-480,000 infants in the U.S. with serious medical conditions are cared for in neonatal intensive care units (NICUs) each year. Maternal stress exposure related to infants' NICU stays is an under-appreciated public health problem with negative implications for maternal and child health and wellbeing. Flexible, effective intervention strategies have potential to improve maternal mental health and parenting, promoting positive emotional and behavioral outcomes for both mothers and infants.

In the investigators' successful pilot research, the investigators developed an audio-delivered mindfulness program to help NICU mothers reduce rumination and worry, cultivate a state of calm awareness, and promote self care. In this small randomized pilot study, the investigators will randomly assign mothers with an infant in the neonatal intensive care unit (NICU) to receive either the mindfulness intervention or an active control program (audio-delivered education on infant care and development).

This study will evaluate feasibility of all key research aspects, including recruitment, randomization, intervention and control conditions, and assessments, in preparation for a future larger-scale study. This study will also assess preliminary intervention outcomes to identify potential program benefits.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female
• 18 to 50 years old
• mother of an infant currently being treated in the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center NICU
• able to speak English

Exclusion criteria

• known to have serious psychopathology
• infant medically unstable/ progress is poor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Mindfulness Program

Experimental group

Description:

The intervention consists of an introductory video in which a mindfulness expert explains the program's approach and models practices to increase women's comfort with the material, four audio-recorded mindfulness practices for mothers' use when the baby is in the NICU, each available in 5- and 10-minute versions, and a brief video and four additional audio mindfulness practices (each available in briefer and longer versions) for use by mothers during and following the transition home with the baby.

Treatment:

Behavioral: Mindfulness Program

Infant Health Education Program

Placebo Comparator group

Description:

The intervention consists of an introductory video explaining the program's approach, four audio recordings providing education about infant health and development, each available in 5- and 10-minute versions, and a brief video and four additional educational recordings (each available in briefer and longer versions) for use by mothers during and following the transition home with the baby.

Treatment:

Behavioral: Infant Health Education Program