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Clinical Trials/NCT03942627
NCT03942627
Completed
N/A

Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

Johns Hopkins University1 site in 1 country76 target enrollmentMay 28, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Johns Hopkins University
Enrollment
76
Locations
1
Primary Endpoint
Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 28, 2019
End Date
October 12, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

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

  • Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)(Up to 2 weeks)
  • Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(4 weeks)
  • Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)(2 weeks)
  • Coping as assessed by the Brief Cope Scale(Up to 2 weeks)

Study Sites (1)

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