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Impact of Journal Program on Wellbeing of NICU Parents

Impact of Journal Program on Wellbeing of NICU Parents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04331925
Enrollment
100
Registered
2020-04-02
Start date
2019-02-01
Completion date
2019-12-12
Last updated
2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

NICU parents, Journaling

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.

Interventions

BEHAVIORALAnxiety 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.

BEHAVIORALJournaling

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

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Change in HADS anxiety scoreBaseline to 2-4 weeksThe 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 scoreBaseline to 2-4 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026