Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nurse Delivered Counseling, Emotional Distress

Intervention / Treatment
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* Behavioral: RCT Treatment -Listening Visits delivered by NICU nurse in person
* Behavioral: RCT Control Usual mental health care delivered by NICU social workers
* Behavioral: Open trial: Listening Visits delivered by a NICU nurse via zoom


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial #1: (RCT) Treatment Group: Listening Visits delivered by NICU nurse in person<br>Listening Visits delivered by a NICU nurse in person in the RCT | Behavioral: RCT Treatment -Listening Visits delivered by NICU nurse in person<br>* 6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.<br>* Other names: Counselling;|
| Active Comparator: Trial #1: (RCT): Control Group -Mental health care delivered by NICU social work<br>Mental health care provided by NICU social workers. | Behavioral: RCT Control Usual mental health care delivered by NICU social workers<br>* RCT Control Usual mental health care delivered by NICU social workers<br>* Other names: Usual Mental Health Care;|
| Experimental: Trial #2Open Trial: Listening Visits delivered by NICU nurse over zoom<br>Open Trial: Listening Visits delivered by NICU nurse over zoom | Behavioral: Open trial: Listening Visits delivered by a NICU nurse via zoom<br>* Open trial: Listening Visits delivered by a NICU nurse via zoom<br>* Other names: Person-centered counselling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Listening Visits, Nurses, Hospitalized newborns