NCT04331925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 31, 2020

Last Update Submit

March 31, 2020

Conditions

AnxietyDepression

Keywords

NICU parentsJournaling

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Anxiety and depression screening

OTHER

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

Behavioral: Anxiety and depression screeningBehavioral: Journaling

Anxiety and depression screening with journaling

EXPERIMENTAL

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

Behavioral: Journaling

Interventions

Anxiety and depression screeningBEHAVIORAL

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.

Anxiety and depression screening
JournalingBEHAVIORAL

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

Anxiety and depression screeningAnxiety and depression screening with journaling

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother, father, and/or legal guardian of infant
  • \> 28 weeks gestation
  • At least 5 days anticipated admission in Vanderbilt NICU

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 33649444DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Amy Weitlauf, PHD

    Vanderbilt University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

February 1, 2019

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)