Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns
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|ClinicalTrials.gov Identifier: NCT03704948|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nurse Delivered Counseling Emotional Distress||Behavioral: Listening Visits Behavioral: Standard Care (Social Work)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel 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 :||October 2020|
|Estimated Study Completion Date :||October 2021|
Experimental: Listening Visits
Listening Visits delivered by a nurse.
Behavioral: Listening Visits
6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.
Active Comparator: Standard of Care (Social Work)
Standard mental health services provided by social workers.
Behavioral: Standard Care (Social Work)
Mental health services provided by social workers to emotionally distressed mothers.
- Mean depression symptoms score [ Time Frame: 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
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
|Contact: Lisa S. Segre, PhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Lisa S. Segre, PhD||University of Iowa|