Emotional Distress, Nurse Delivered Counseling
Conditions
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
6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.
RCT Control Usual mental health care delivered by NICU social workers
Open trial: Listening Visits delivered by a NICU nurse via zoom
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 51 |
Baseline characteristics
| Characteristic | Trial #1 (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person | Total | Trial #2 (Open Trial Due to Pandemic) Listening Visits Delivered Via Zoom by a NICU Nurse | Trial #1 (RCT) Control Group: Mental Health Care Delivered by NICU Social Work |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 51 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 51 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Mean Score IDAS-GD | 53.50 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 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 40 Participants | 7 Participants | 16 Participants |
| Region of Enrollment United States | 20 Participants | 51 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Female | 20 Participants | 51 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 | 0 / 9 |
| other Total, other adverse events | 0 / 20 | 0 / 22 | 0 / 9 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 | 0 / 9 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trial #1: (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 4 Weeks (end of treatment) | 46.12 score on a scale | Standard Deviation 12.74 |
| Trial #1: (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 8 Weeks (follow up) | 42.39 score on a scale | Standard Deviation 12.37 |
| Trial #1: (RCT): Control Group -Mental Health Care Delivered by NICU Social Work | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 4 Weeks (end of treatment) | 51.10 score on a scale | Standard Deviation 13.32 |
| Trial #1: (RCT): Control Group -Mental Health Care Delivered by NICU Social Work | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 8 Weeks (follow up) | 41.69 score on a scale | Standard Deviation 13.32 |
| Trial #2Open Trial: Listening Visits Delivered by NICU Nurse Over Zoom | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 4 Weeks (end of treatment) | 40.11 score on a scale | Standard Deviation 13.78 |
| Trial #2Open Trial: Listening Visits Delivered by NICU Nurse Over Zoom | Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up) | 8 Weeks (follow up) | 32.39 score on a scale | Standard Deviation 10.04 |