Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704948
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
Lisa Segre, University of Iowa

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Nurse Delivered Counseling Emotional Distress Behavioral: Listening Visits via zoom Not Applicable

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. Because outcomes of infants will be obtained, the IRB has required that they be enrolled by their mothers as subjects so that data on their outcomes can be obtained. However, they are not receiving the intervention. 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 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Promoting Emotional Well-Being in Distressed NICU (Neonatal Intensive Care Unit) Mothers: A Phase 2 Evaluation of a Nurse-Delivered Approach
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Listening Visits
Listening Visits delivered by a nurse via zoom
 Behavioral: Listening Visits via zoom
6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.
Other Names:
  • Person-centered counselling
  • Counselling


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in depression symptoms score [ Time Frame: 4 and 8 weeks post enrollment ]
    • Scale: Inventory of Depression & Anxiety Symptoms-General Depression (sub) Scale (IDAS-GD).
    • The IDAS-GD assesses depression symptoms
    • The IDAS-GD is a 2-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

  2. Change in depression symptom Score [ Time Frame: 4 and 8 weeks post enrollment ]
    Edinburgh Postnatal Depression Scale


Secondary Outcome Measures :
  1. Reliable Change Index [ Time Frame: 4 and 8 weeks post enrollment ]
    Reliable change of depression scores using EPDS and IDAS-GD


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704948


Contacts
Layout table for location contacts
Contact: Lisa S. Segre, PhD 319-335-7079 lisa-segre@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Stead Family Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lisa S. Segre, PhD    319-335-7079    lisa-segre@uiowa.edu   
Sponsors and Collaborators
Lisa Segre
Investigators
Layout table for investigator information
Principal Investigator: Lisa S. Segre, PhD University of Iowa
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Lisa Segre, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03704948    
Other Study ID Numbers: 201805961
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Segre, University of Iowa:
Depression
Listening Visits
Nurses
Hospitalized newborns