Impact of Journal Program on Wellbeing of NICU Parents

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Journal Program on Wellbeing of NICU Parents

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Anxiety and depression screening
* Behavioral: Journaling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anxiety and depression screening<br>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<br>* 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.<br>Behavioral: Journaling<br>* 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<br>|
| Experimental: Anxiety and depression screening with journaling<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICU parents, Journaling