Anxiety, Depressive Symptoms, Post-traumatic Stress Symptoms
Conditions
Keywords
mindfulness, maternal depression
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALInfant 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ) | 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. |
| Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU) | 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. |
| Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | 4 weeks | Self-reported measure assessing sleep quality |
| Coping as assessed by the Brief Cope Scale | 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) |
Countries
United States
Outcome results
None listed