Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

Not Applicable

Completed

• Conditions: Depressive Symptoms; Anxiety; Post-traumatic Stress Symptoms
• Interventions: Behavioral: Mindfulness Program; Behavioral: Infant Health Education Program

• Registration Number: NCT03942627
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-05-28
• Status Verified: 2020-10
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Program	Mindfulness Program	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.
Infant Health Education Program	Infant Health Education Program	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.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8	2 weeks	Self-reported depressive symptoms over the last 2 weeks. Each of the 8 items is scored 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 24. Higher scores mean more depressive symptoms.
Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)	2 weeks	Self-reported anxiety symptoms over the last 2 weeks. Each of the 7 items is rated from 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 21. Higher scores mean more anxiety.

Secondary Outcome Measures

Name	Time	Method
Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)	Up to 2 weeks	Self-report measure of perceived stress related to the NICU containing 4 sub scales, each with items rated on a scale of 1 (not at all stressful) to 5 (very stressful). Higher scores mean more stress.
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	4 weeks	Self-reported measure assessing sleep quality
Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)	2 weeks	31-item self-report measure of trauma symptoms. Items 1-30 are rated from 0 (not experienced) to 5 (very often experienced). Item 31 asks how many days symptoms were experienced since giving birth, ranging from no days to 5 or more days. Higher scores mean more frequent experience of trauma symptoms.
Coping as assessed by the Brief Cope Scale	Up to 2 weeks	28-item self-reported measure of coping strategies. Items are rated on a scale ranging from 1 ("I usually don't do this at all") to 4 ("I usually do this a lot")

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States