Impact of Journal Program on Wellbeing of NICU Parents

March 31, 2020 updated by: Laura Shashy, Vanderbilt University Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Anxiety and depression screening
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 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.
Behavioral: Journaling
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
EXPERIMENTAL: Anxiety and depression screening with journaling
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 2-4 weeks
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.
Baseline to 2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Study Chair: Amy Weitlauf, PHD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 12, 2019

Study Completion (ACTUAL)

December 12, 2019

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (ACTUAL)

April 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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