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Clinical Trials/NCT04331925
NCT04331925CompletedNot Applicable

Impact of Journal Program on Wellbeing of NICU Parents

Vanderbilt University Medical Center2 sites in 1 country100 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Change in HADS anxiety score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in HADS anxiety score

Time Frame: Baseline to 2-4 weeks

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

Time Frame: Baseline to 2-4 weeks

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Shashy

Clinical Fellow

Vanderbilt University Medical Center

Study Sites (2)

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