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Impact of Journal Program on Wellbeing of NICU Parents

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety and depression screening
Journaling
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anxiety focused on measuring NICU parents, Journaling

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Anxiety and depression screening

Anxiety and depression screening with journaling

Arm Description

Hospital Anxiety and Depression Scale (HADS) questionnaire administered at the start of the study. After two weeks or at the time of discharge, participants will complete the HADS questionnaire again

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. They will also complete the HADS questionnaire before and after the intervention period of two weeks. At the end of the intervention period, these parents will also complete a survey regarding their experience with journaling

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2020
Last Updated
March 31, 2020
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04331925
Brief Title
Impact of Journal Program on Wellbeing of NICU Parents
Official Title
Impact of Journal Program on Wellbeing of NICU Parents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
NICU parents, Journaling

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety and depression screening
Arm Type
Other
Arm Description
Hospital Anxiety and Depression Scale (HADS) questionnaire administered at the start of the study. After two weeks or at the time of discharge, participants will complete the HADS questionnaire again
Arm Title
Anxiety and depression screening with journaling
Arm Type
Experimental
Arm Description
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. They will also complete the HADS questionnaire before and after the intervention period of two weeks. At the end of the intervention period, these parents will also complete a survey regarding their experience with journaling
Intervention Type
Behavioral
Intervention Name(s)
Anxiety and depression screening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Journaling
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in HADS anxiety score
Description
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.
Time Frame
Baseline to 2-4 weeks
Title
Change in HADS depression score
Description
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.
Time Frame
Baseline to 2-4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Weitlauf, PHD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33649444
Citation
Russell LN, Gregory ML, Warren ZE, Weitlauf AS. Uptake and impact of journaling program on wellbeing of NICU parents. J Perinatol. 2021 Aug;41(8):2057-2062. doi: 10.1038/s41372-021-00983-1. Epub 2021 Mar 1.
Results Reference
derived

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Impact of Journal Program on Wellbeing of NICU Parents

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