Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Post-traumatic Stress Symptoms
• Intervention / Treatment: Behavioral: Mindfulness Program; Behavioral: Infant Health Education Program

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness Program; The intervention consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of mindfulness practices delivered via audio recordings to assist mothers in managing stress during the NICU stay and another series for the transition home.
Placebo Comparator: 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.	Behavioral: Infant Health Education Program; The active control condition consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of audio recordings providing information on infant health and development for mothers to use during the NICU stay and another series for the transition home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8	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.	2 weeks
Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)	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.	2 weeks
Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)	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.	Up to 2 weeks
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	Self-reported measure assessing sleep quality	4 weeks
Coping as assessed by the Brief Cope Scale	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")	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Erica Sibinga, M.D., Ph.D., Johns Hopkins University

Publications and helpful links

General Publications

• Mendelson T, McAfee C, Damian AJ, Brar A, Donohue P, Sibinga E. A mindfulness intervention to reduce maternal distress in neonatal intensive care: a mixed methods pilot study. Arch Womens Ment Health. 2018 Dec;21(6):791-799. doi: 10.1007/s00737-018-0862-x. Epub 2018 Jun 5.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: mindfulness; maternal depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IRB00159072; R34AT009615 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No