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Completed

NCT Number: NCT03942627

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.

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Key information

Conditions

Depressive Symptoms Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Post-traumatic Stress Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness program

Behavioral

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.

Infant Health Education Program

Behavioral

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.

Primary outcomes

  1. Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8

    Time frame: 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.

  2. Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)

    Time frame: 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 outcomes

  1. Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)

    Time frame: 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.

  2. Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)

    Time frame: 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.

  3. Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 weeks

    Self-reported measure assessing sleep quality

  4. Coping as assessed by the Brief Cope Scale

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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