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Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

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ClinicalTrials.gov Identifier: NCT03942627
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Post-traumatic Stress Symptoms Behavioral: Mindfulness Program Behavioral: Infant Health Education Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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")



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942627


Contacts
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Contact: Tamar Mendelson, Ph.D. (410)502-6219 tmendel1@jhu.edu
Contact: Erica Sibinga, M.D., Ph.D. (410)550-4134 esibinga@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Tamar Mendelson, PHD    410-502-6219    tmendel1@jhu.edu   
Contact: Tracey Chambers-Thomas, B.S.    (410)550-6507    tchambe5@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Erica Sibinga, M.D., Ph.D. Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03942627     History of Changes
Other Study ID Numbers: IRB00159072
R34AT009615 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
mindfulness
maternal depression

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms