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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR016751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial #1: (RCT) Treatment Group: Listening Visits delivered by NICU nurse in person | Experimental | Listening Visits delivered by a NICU nurse in person in the RCT |
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| Trial #1: (RCT): Control Group -Mental health care delivered by NICU social work | Active Comparator | Mental health care provided by NICU social workers. |
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| Trial #2Open Trial: Listening Visits delivered by NICU nurse over zoom | Experimental | Open Trial: Listening Visits delivered by NICU nurse over zoom |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RCT Treatment -Listening Visits delivered by NICU nurse in person | Behavioral | 6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) |
| 4 weeks and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria Women is not currently receiving counseling services
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| Name | Affiliation | Role |
|---|---|---|
| Lisa S. Segre, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Stead Family Children's Hospital | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25486371 | Background | Segre LS, Brock RL, O'Hara MW. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial. J Consult Clin Psychol. 2015 Apr;83(2):314-24. doi: 10.1037/a0038495. Epub 2014 Dec 8. | |
| 23949835 | Background | Segre LS, Chuffo-Siewert R, Brock RL, O'Hara MW. Emotional distress in mothers of preterm hospitalized infants: a feasibility trial of nurse-delivered treatment. J Perinatol. 2013 Dec;33(12):924-8. doi: 10.1038/jp.2013.93. Epub 2013 Aug 15. |
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No significant events after participant enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Jul 20, 2023 |
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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.
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| RCT Control Usual mental health care delivered by NICU social workers | Behavioral | RCT Control Usual mental health care delivered by NICU social workers |
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| Open trial: Listening Visits delivered by a NICU nurse via zoom | Behavioral | Open trial: Listening Visits delivered by a NICU nurse via zoom |
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| Trial #1 (RCT) Control Group: Usual 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 |
| FG002 | Trial #2 (Exploratory Open Trial Due to Pandemic) Listening Visits Delivered Via Zoom | Open trial of Listening Visits delivered by NICU nurses via zoom. When Trial 1 (RCT) was halted because of the pandemic, we conducted a small, open trial evaluating Listening Visits delivered by NICU nurses via zoom. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | 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." |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mean Score IDAS-GD | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) |
| Posted | Mean | Standard Deviation | score on a scale | 4 weeks and 8 weeks |
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Up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trial #1 RCT Treatment Group Listening Visits Delivered by NICU Nurses in Person | Trial #1 RCT Treatment Group Listening Visits delivered by NICU nurses in person | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Trial #1 RCT Control Group-Usual Mental Health Care From Social Work | Trial #1 RCT Control Group-Usual mental health care from social work | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Trial #2: Listening Visits Delivered Via Zoom | Trial #2: Listening Visits delivered via zoom | 0 | 9 | 0 | 9 | 0 | 9 |
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Trial #1: RCT-Small sample, lack of ethnic/racial diversity in the sample, types of treatment used by usual care group was not documented Trial #2: Open Trial: Small, sample, lack of ethnic/racial diversity
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa S. Segre | University of Iowa | 13193357079 | lisa-segre@uiowa.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2021 | Jul 20, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2020 | Jul 24, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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