Clinical trial NCT03942627: Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
Official title: Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Post-traumatic Stress Symptoms
Keywords: mindfulness
maternal depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-05-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
timeFrame: 2 weeks
measure: Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: 2 weeks
Secondary outcomes:
measure: Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)
timeFrame: 2 weeks
measure: Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)
timeFrame: Up to 2 weeks
measure: Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
measure: Coping as assessed by the Brief Cope Scale
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Erica Sibinga, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.