Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

NCT03942627 | Completed DMC

• 2 other identifiers: IRB00159072R34AT009615
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Post-traumatic Stress Symptoms

Keywords

mindfulness; maternal depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  2 weeks

• 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

• Coping as assessed by the Brief Cope Scale

  Up to 2 weeks

Study Arms (2)

Mindfulness Program

EXPERIMENTAL

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

Infant Health Education Program

PLACEBO COMPARATOR

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

Interventions

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.

Mindfulness Program

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.

Infant Health Education Program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• 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

You may not qualify if:

• known to have serious psychopathology
• infant medically unstable/ progress is poor

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 29872924 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Erica Sibinga, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: May 28, 2019
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: October 27, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)