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Completed

NCT Number: NCT04331925

Impact of Journal Program on Wellbeing of NICU Parents

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety and depression screening

Behavioral

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

Behavioral

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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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