Impact of Journal Program on Wellbeing of NICU Parents

Depression Clinical Trial

Official title:

Impact of Journal Program on Wellbeing of NICU Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331925
• Other study ID #: 181831
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: March 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the impact of a journaling program on rates of anxiety and depression in neonatal intensive care unit (NICU) parents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mother, father, and/or legal guardian of infant

• > 28 weeks gestation

• At least 5 days anticipated admission in Vanderbilt NICU

Exclusion Criteria:

• < 28 weeks gestation

• Expected death or discharge within 5 days of admission

• Primary medical team feels that participation would be disruptive or detrimental to infant's care

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Anxiety and depression screening
At the time of consent, the participant parent will be randomized into either the control or intervention groups. The control group will complete the Hospital Anxiety and Depression Scale (HADS) questionnaire at the start of the study. After two weeks or at the time of discharge, the control group will complete the HADS questionnaire again.
• Journaling
Parents randomized into the intervention group be given verbal instructions to use a journal how/when they choose for the duration of the intervention period

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HADS anxiety score	The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. The range of scores for anxiety is 0 to 21. A score of 0 is no anxiety. A score of 1-7 indicates some anxiety. A score of greater than or equal to 8 is the cut-off for clinical anxiety.	Baseline to 2-4 weeks
Primary	Change in HADS depression score	The HADS is a fourteen item scale that generates: Seven of the items relate to depression and seven relate to anxiety. The range of scores for depression is 0 to 21. A score of 0 is no depression. A score of 1-7 indicates some depression. A score of greater than or equal to 8 is the cut-off for clinical depression.	Baseline to 2-4 weeks