Trial Outcomes & Findings for Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns (NCT NCT03704948)
NCT ID: NCT03704948
Last Updated: 2023-09-29
Results Overview
* 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
4 weeks and 8 weeks
Results posted on
2023-09-29
Participant Flow
No significant events after participant enrollment.
Participant milestones
| Measure |
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.
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
10
|
|
Overall Study
COMPLETED
|
20
|
22
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns
Baseline characteristics by cohort
| Measure |
Trial #1 (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person
n=20 Participants
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.
|
Trial #1 (RCT) Control Group: Mental Health Care Delivered by NICU Social Work
n=22 Participants
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
|
Trial #2 (Open Trial Due to Pandemic) Listening Visits Delivered Via Zoom by a NICU Nurse
n=9 Participants
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."
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Mean Score IDAS-GD
|
53.50 units on a scale
STANDARD_DEVIATION 11.35 • n=5 Participants
|
53.00 units on a scale
STANDARD_DEVIATION 14.12 • n=7 Participants
|
56.89 units on a scale
STANDARD_DEVIATION 11.85 • n=5 Participants
|
53.88 units on a scale
STANDARD_DEVIATION 12.53 • n=4 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Trial #1: (RCT) Treatment Group: Listening Visits Delivered by NICU Nurse in Person
n=16 Participants
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.
|
Trial #1: (RCT): Control Group -Mental Health Care Delivered by NICU Social Work
n=21 Participants
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
|
Trial #2Open Trial: Listening Visits Delivered by NICU Nurse Over Zoom
n=9 Participants
Open Trial: Listening Visits delivered by NICU nurse over zoom
Open trial: Listening Visits delivered by a NICU nurse via zoom: Open trial: Listening Visits delivered by a NICU nurse via zoom
|
|---|---|---|---|
|
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
|
51.10 score on a scale
Standard Deviation 13.32
|
40.11 score on a scale
Standard Deviation 13.78
|
|
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
|
41.69 score on a scale
Standard Deviation 13.32
|
32.39 score on a scale
Standard Deviation 10.04
|
Adverse Events
Trial #1 RCT Treatment Group Listening Visits Delivered by NICU Nurses in Person
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial #1 RCT Control Group-Usual Mental Health Care From Social Work
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial #2: Listening Visits Delivered Via Zoom
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place