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Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns

Promoting Emotional Well-Being in Distressed NICU (Neonatal Intensive Care Unit) Mothers: A Phase 2 Evaluation of a Nurse-Delivered Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704948
Enrollment
55
Registered
2018-10-15
Start date
2019-02-14
Completion date
2022-06-20
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Distress, Nurse Delivered Counseling

Keywords

Depression, Listening Visits, Nurses, Hospitalized newborns

Brief summary

The proposed research has potential to dramatically improve care for emotionally distressed mothers of newborns hospitalized on the neonatal intensive care unit (NICU). Clinical NICU nurses are well-positioned to provide emotional support in the form of Listening Visits. Specifically, these nurses are easily accessible to NICU mothers, are often the most trusted professional on the healthcare team, they are knowledgeable about the newborn's medical conditions, and, finally they are already skilled in the art of warm communication. This intervention should not only improve depressive outcomes in emotionally distressed NICU mothers but also indirectly impact maternal perception of nurse support which is in turn related to depression symptoms and patient satisfaction, as well as infant length of stay by accelerating maternal readiness for infant discharge.

Detailed description

Infant admission to the neonatal intensive care unit (NICU) is an extremely stressful postpartum outcome, as evidenced by data showing significant depressive symptoms in some 63% of new NICU mothers. Thus, as part of a Family-Centered Care philosophy, focus on the emotional well-being of the mother (and indeed the entire family) should be widely adopted by NICU nursing units. In current clinical practice, however, the emotional well-being of NICU mothers is often ignored. At best, NICU mothers are screened for depression and if indicated, referred to a mental health professional. The extremes of no treatment and full-on mental healthcare comprise an inadequate approach for treating mothers dealing with a normative reaction to a stressful event. In alignment with the Nurse Parent Support Model, the investigators propose the implementation of Listening Visits as a cost-effective nurse-delivered supportive approach, proven to relieve moderately severe depressive symptoms in mothers of term infants. In the NICU setting, Listening Visits were first implemented in a phase-1 feasibility trial conducted by this research team. In that first trial, Listening Visits were delivered by a doctoral-level nurse practitioner and showed promise as means to reduce distress in NICU mothers. A Listening Visit program for emotionally distressed NICU mothers is innovative because it is a cost-effective approach that uses resources that are largely in place, to serve a persistent unmet need in a vulnerable postpartum population. By having nurses provides support, the concept of emotional distress in NICU mothers is normalized. This new application of Listening Visits also directly aligns with the NINR emphasis on promoting coping to prevent compromising mood states. The promising results of the feasibility trial now must be challenged with a control group comparison to definitively attribute maternal improvements to Listening Visits. Thus the objective of the proposed research is to conduct a Phase 2 pilot RCT to evaluate Listening Visits provided by bachelor's-level NICU nurses as compared with the care currently provided by the NICU social work team. The investigators will assess the relative effectiveness of Listening Visits vs. standard care on depressive symptoms. 50 women will be randomized into this trial.Due to the pandemic, recruitment for the RCT was halted with 45 women enrolled. Enrollment to the RCT of Listening Visits is closed. With approval from NINR, the IRB protocol of the RCT was modified to an open trial design, in which women received Listening Visits from a NICU nurse via Zoom. The goal is to enroll 20 women. In consultation with the Human Subjects Office University of Iowa (who in turn consulted with staff of Clinical Trials.gov), the study design section of this clinical trials registration number is updated to reflect the ongoing open trial design. We enrolled 55 participants. For the first 45, the study model was parallel. Group 1 received Listening Visits and Group 2 received usual mental health care from a NICU social worker. After the study modification design due to the pandemic, the study model was changed to a single group and they received Listening Visits over Zoom from a NICU nurse. We have listed the three arms based on both study designs.

Interventions

BEHAVIORALRCT Treatment -Listening Visits delivered by NICU nurse in person

6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.

BEHAVIORALRCT Control Usual mental health care delivered by NICU social workers

RCT Control Usual mental health care delivered by NICU social workers

BEHAVIORALOpen trial: Listening Visits delivered by a NICU nurse via zoom

Open trial: Listening Visits delivered by a NICU nurse via zoom

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

We enrolled 55 participants. For the first 45, the study model was parallel. Group 1 received Listening Visits and Group 2 received usual mental health care from a NICU social worker. After study modification design due to the pandemic, the study model was changed to singe group and they received Listening Visits over zoom from a NICU nurse.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ability to speak and read English * 18 years of age or older Edinburgh Postnatal Depression Scale (EPDS) score= 12 through 19, inclusive; with a rating of 2 or less on EPDS item #10) * Hospitalized newborn

Exclusion criteria

Women is not currently receiving counseling services

Design outcomes

Primary

MeasureTime frameDescription
Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)4 weeks and 8 weeks* Scale: Inventory of Depression & Anxiety Symptoms-General Depression (sub) Scale (IDAS-GD). * The IDAS-GD assesses depression symptoms * The IDAS-GD is a 20-item Likert-scale instrument assesses dysphoria, suicidality, lassitude, insomnia, appetite loss and well-being, using a 5-point scale ranging from not at all to extremely, indicating how much they had experienced each symptom during the past 2 weeks. * Total score for IDAS-GD can range from 1-100, with higher scores indicating more depression symptoms

Countries

United States

Participant flow

Pre-assignment details

No significant events after participant enrollment.

Participants by arm

ArmCount
Trial #1 (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person
Listening Visits delivered by a NICU nurse in person in the RCT RCT Treatment -Listening Visits delivered by NICU nurse in person: 6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.
20
Trial #1 (RCT) Control Group: Mental Health Care Delivered by NICU Social Work
Mental health care provided by NICU social workers. RCT Control Usual mental health care delivered by NICU social workers: RCT Control Usual mental health care delivered by NICU social workers
22
Trial #2 (Open Trial Due to Pandemic) Listening Visits Delivered Via Zoom by a NICU Nurse
Trial 1, the RCT (Arms 1 and 2) were halted because of the pandemic with 45 of the 50 projected participants enrolled. We closed enrollment to the RCT and pivoted (with NINR approval) conduct an exploratory open trial of Listening Visits delivered via zoom by a NICU nurse. As directed by NIH help desk, the data for Arm 3 (the open trial of Listening Visits delivered via zoom by a NICU nurse) is reported here as Arm 3.
9
Total51

Baseline characteristics

CharacteristicTrial #1 (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in PersonTotalTrial #2 (Open Trial Due to Pandemic) Listening Visits Delivered Via Zoom by a NICU NurseTrial #1 (RCT) Control Group: Mental Health Care Delivered by NICU Social Work
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants51 Participants9 Participants22 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants51 Participants9 Participants22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Mean Score IDAS-GD53.50 units on a scale
STANDARD_DEVIATION 11.35
53.88 units on a scale
STANDARD_DEVIATION 12.53
56.89 units on a scale
STANDARD_DEVIATION 11.85
53.00 units on a scale
STANDARD_DEVIATION 14.12
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants6 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants40 Participants7 Participants16 Participants
Region of Enrollment
United States
20 Participants51 Participants9 Participants22 Participants
Sex: Female, Male
Female
20 Participants51 Participants9 Participants22 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 220 / 9
other
Total, other adverse events
0 / 200 / 220 / 9
serious
Total, serious adverse events
0 / 200 / 220 / 9

Outcome results

Primary

Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)

* Scale: Inventory of Depression & Anxiety Symptoms-General Depression (sub) Scale (IDAS-GD). * The IDAS-GD assesses depression symptoms * The IDAS-GD is a 20-item Likert-scale instrument assesses dysphoria, suicidality, lassitude, insomnia, appetite loss and well-being, using a 5-point scale ranging from not at all to extremely, indicating how much they had experienced each symptom during the past 2 weeks. * Total score for IDAS-GD can range from 1-100, with higher scores indicating more depression symptoms

Time frame: 4 weeks and 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Trial #1: (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in PersonMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)4 Weeks (end of treatment)46.12 score on a scaleStandard Deviation 12.74
Trial #1: (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in PersonMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)8 Weeks (follow up)42.39 score on a scaleStandard Deviation 12.37
Trial #1: (RCT): Control Group -Mental Health Care Delivered by NICU Social WorkMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)4 Weeks (end of treatment)51.10 score on a scaleStandard Deviation 13.32
Trial #1: (RCT): Control Group -Mental Health Care Delivered by NICU Social WorkMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)8 Weeks (follow up)41.69 score on a scaleStandard Deviation 13.32
Trial #2Open Trial: Listening Visits Delivered by NICU Nurse Over ZoomMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)4 Weeks (end of treatment)40.11 score on a scaleStandard Deviation 13.78
Trial #2Open Trial: Listening Visits Delivered by NICU Nurse Over ZoomMean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)8 Weeks (follow up)32.39 score on a scaleStandard Deviation 10.04
p-value: <0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026