AnxietyNCT04331925
Impact of Journal Program on Wellbeing of NICU Parents
A study testing Anxiety and depression screening and Journaling in people with Anxiety and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Anxiety and depression screening and Journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother, father, and/or legal guardian of infant
- > 28 weeks gestation
- At least 5 days anticipated admission in Vanderbilt NICU
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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.
- Conditions
- Anxiety, Depression
- Being tested
- Anxiety and depression screening, Journaling
- Keywords
- NICU parents, Journaling
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety and depression screeningBehavioural
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.
JournalingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Anxiety and depression screening; Behavioral: 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 Receives: Behavioral: Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Feb 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Shashy, Vanderbilt University Medical Center
- Investigators
- Amy Weitlauf, PHD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331925
- Sponsor's protocol ID
- 181831
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33649444
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Journal Program on Wellbeing of NICU Parents
- ClinicalTrials.gov ID
- NCT04331925
- Acronym / sponsor ID
- 181831
- Conditions
- Anxiety, Depression
- Keywords
- NICU parents, Journaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety and depression screening | Other | Behavioral: Anxiety and depression screening, Behavioral: JournalingHospital 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 |
| Anxiety and depression screening with journaling | Experimental | Behavioral: JournalingParents 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mother, father, and/or legal guardian of infant
- > 28 weeks gestation
- At least 5 days anticipated admission in Vanderbilt NICU
Key exclusion criteria (3 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety and depression screeningAt 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. | Behavioural | Anxiety and depression screening |
| JournalingParents randomized into the intervention group be given verbal instructions to use a journal how/when they choose for the duration of the intervention period | Behavioural | Anxiety and depression screening, Anxiety and depression screening with journaling |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 33649444Russell 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Weitlauf, PHD study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety and depression screening and Journaling in people with Anxiety and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HADS anxiety score (time frame: Baseline to 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.