SuicideNCT06079853
Nurse Suicide: Physiologic Sleep Health Promotion Trial
A study testing PureSomni Sleep Health Product Kit in people with Suicide and Nurse's Role, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to identify factors (sleep, psychiatric characteristics, stressful life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors that predispose nurses to suicidal risk. The specific aims are: Aim 1. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Nurse's Role, Work Environment Adverse Effects
- What is being tested?
- PureSomni Sleep Health Product Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently practicing as a registered nurse in the clinical setting
- have worked continuously in the same position for at least 1 year
- read, speak, and understand English language
Who cannot join
- >1-month sick leave in the past 3 months
- pregnancy (known physiologic stress confounder)
- other healthcare workers (e.g., physicians).
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Hudson Valley Hospital
Cortlandt Manor, New York, 10567
About this study
Official title: The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate Predisposing Factors of Suicidal Ideation in Nurses
The purpose of this study is to identify factors (sleep, psychiatric characteristics, stressful life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors that predispose nurses to suicidal risk.
The specific aims are:
Read more
Aim 1. To investigate associations between sleep, stressful life events (life stressors, discrimination, lateral violence), psychiatric characteristics (psychiatric diagnosis, subjective mood), work environment characteristics (workload, shift type and duration, overtime, nurse work environment, and team relations) and stress (self-report and heart rate variability) in working nursing professionals while controlling for standard covariates known to influence stress.
Aim 2. To determine if stress exposure (self-report and HRV) is associated with predisposing factors (sleep, stressful life events, additional psychiatric characteristics, and work environment characteristics), and to explore whether stress mediates the effect of predisposing factors on suicidal ideation in working nursing professionals.
Exploratory Aim. To explore the preliminary impact of an existing sleep intervention (sleep health promotion kit) on self-reported stress, HRV, sleep, and psychiatric health outcomes including depression, burnout, and suicidal ideation.
This record will focus on the Exploratory Aim.
Read the detailed description
Despite being the largest healthcare workforce in the United States (US) (~5 million nurses), evidence about suicidal ideation and predisposing factors that contribute to suicide in nurses is limited. Outside of nursing, there is substantial evidence that an individual's psychiatric characteristics (psychiatric diagnosis; decision-making; social cognition; mood) and/or life stressors (e.g., death of a loved one, divorce, discrimination, or lateral violence) are significantly associated to suicidal ideation. Yet, it is unclear why nurses have higher rates of suicide compared to other populations and which factors predispose nurses to higher risk for suicidal behavior. It has become critical to test new approaches to reduce stress in nurses and subsequently mitigate suicide ideation. There is early evidence that sleep disturbances may induce increased stress and subsequently higher psychological risk, including depression, a known predisposing risk factor for suicidal risk. Evidence about the associations between sleep and suicidal ideation is limited but early studies show promise that interventions promoting sleep health may help mitigate suicidal risk. The isolation of predisposing factors for stress in nurses and investigation of potential interventions to counteract such stress may help to identify and mitigate suicide risk in nurses. Past evidence about suicide has been limited to post-mortem data inhibiting an understanding of which personal, psychosocial, and work environment factors predispose a nurse to suicidal behaviors. The combined study of self-report and physiologic data may help us better understand sources of stress adaptation in the search for underlying biological mechanisms associated with suicide and other suboptimal psychologic health outcomes.
- Conditions
- Suicide, Nurse's Role, Work Environment Adverse Effects, Sleep, Stress, Mental Health Wellness 1
- Being tested
- PureSomni Sleep Health Product Kit
- Keywords
- Suicide, Nurse, Sleep, Mental Health, Work Environment, Stress, Depression, Anxiety
- Medical subject headings
- Suicide, Occupational Stress, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureSomni Sleep Health Product KitBehavioural
PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Single arm pilot sample will receive intervention Receives: Behavioral: PureSomni Sleep Health Product Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Baseline (Week 1).
CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Measured: Baseline: Week 1
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 4).
CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Measured: Follow-up: Week 4
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 8).
CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Measured: Follow-up: Week 8
Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)]
Participants will wear the OuraRing to capture physiologic continuous heart rate variability. Heart rate variability is the variance in time between heart beats (RR intervals on an EKG) and is calculated using root mean square of successive differences between heartbeats. The middle 50% of 20-25 year olds usually have an average HRV in the 55-105 range, while 60-65 year olds tend to be between 25-45. In general, a higher heart rate variability is considered better as it indicates a more adaptable and resilient autonomic nervous system, which can respond effectively to different stressors. We calculated the mean difference between the control time period (Week1-4) and the intervention time period (Week 5-8).
Measured: 8 weeks
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Measured: baseline-Week 1
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Measured: Follow up- Week 4
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Measured: Follow up- Week 8
Physiologic Sleep Data - Sleep Duration (Mean Daily Hours)
This is to measure the average amount of daily sleep (hours) over an 8 week period. The physiologic data is collected via a wearable device (OuraRing).
We calculated the mean difference in sleep duration (hours) between Week 1-4 (Control time period) and Week 5-8(Intervention time period).
Measured: 8 weeks
Number of Participants With at Least 1 Suicidal Behavior (Frequency)
Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.
Measured: 8 Weeks
Secondary outcomes (6)
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
Scaling - Self report survey (subscale 1-emotional exhaustion) 7 point Likert Scale; Score Range 0-42
Interpretation:
17 or less - Low level of burnout 18-29 - Moderate level of burnout Greater than 30 - High level of burnout
Measured: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Scaling - Self report survey (subscale 2-Depersonalization) 7 point Likert Scale; Score Range 0-42
Interpretation:
5 or less - Low level of burnout 6-11 - Moderate level of burnout Greater than 12 - High level of burnout
Measured: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score
Scaling - Self report survey (subscale 3-Personal Achievement) 7 point Likert Scale; Score Range 0-48
Interpretation:
33 or less - Low level of burnout 34-39 - Moderate level of burnout Greater than 40 - High level of burnout
Measured: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
Scaling - Self report survey (subscale 1-emotional exhaustion) 7 point Likert Scale; Score Range 0-42
Interpretation:
17 or less - Low level of burnout 18-29 - Moderate level of burnout Greater than 30 - High level of burnout
Measured: Week 8
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Scaling - Self report survey (subscale 2-Depersonalization) 7 point Likert Scale; Score Range 0-42
Interpretation:
5 or less - Low level of burnout 6-11 - Moderate level of burnout Greater than 12 - High level of burnout
Measured: Week 8
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score
Scaling - Self report survey (subscale 3-Personal Achievement) 7 point Likert Scale; Score Range 0-48
Interpretation:
33 or less - Low level of burnout 34-39 - Moderate level of burnout Greater than 40 - High level of burnout
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start8 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Norful, Columbia University
- Investigators
- Allison A Norful, PhD, Principal investigator, Columbia University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079853
- Sponsor's protocol ID
- AAAU3204
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate Predisposing Factors of Suicidal Ideation in Nurses
- ClinicalTrials.gov ID
- NCT06079853
- Acronym / sponsor ID
- AAAU3204
- Conditions
- Suicide, Nurse's Role, Work Environment Adverse Effects, Sleep, Stress, Mental Health Wellness 1
- Keywords
- Suicide, Nurse, Sleep, Mental Health, Work Environment, Stress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 25 Nov 2024
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 identify factors (sleep, psychiatric characteristics, stressful life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors that predispose nurses to suicidal risk.
The specific aims are:
Aim 1. To investigate associations between sleep, stressful life events (life stressors, discrimination, lateral violence), psychiatric characteristics (psychiatric diagnosis, subjective mood), work environment characteristics (workload, shift type and duration, overtime, nurse work environment, and team relations) and stress (self-report and heart rate variability) in working nursing professionals while controlling for standard covariates known to influence stress.
Aim 2. To determine if stress exposure (self-report and HRV) is associated with predisposing factors (sleep, stressful life events, additional psychiatric characteristics, and work environment characteristics), and to explore whether stress mediates the effect of predisposing factors on suicidal ideation in working nursing professionals.
Exploratory Aim. To explore the preliminary impact of an existing sleep intervention (sleep health promotion kit) on self-reported stress, HRV, sleep, and psychiatric health outcomes including depression, burnout, and suicidal ideation.
This record will focus on the Exploratory Aim.
Detailed description
Despite being the largest healthcare workforce in the United States (US) (~5 million nurses), evidence about suicidal ideation and predisposing factors that contribute to suicide in nurses is limited. Outside of nursing, there is substantial evidence that an individual's psychiatric characteristics (psychiatric diagnosis; decision-making; social cognition; mood) and/or life stressors (e.g., death of a loved one, divorce, discrimination, or lateral violence) are significantly associated to suicidal ideation. Yet, it is unclear why nurses have higher rates of suicide compared to other populations and which factors predispose nurses to higher risk for suicidal behavior. It has become critical to test new approaches to reduce stress in nurses and subsequently mitigate suicide ideation. There is early evidence that sleep disturbances may induce increased stress and subsequently higher psychological risk, including depression, a known predisposing risk factor for suicidal risk. Evidence about the associations between sleep and suicidal ideation is limited but early studies show promise that interventions promoting sleep health may help mitigate suicidal risk. The isolation of predisposing factors for stress in nurses and investigation of potential interventions to counteract such stress may help to identify and mitigate suicide risk in nurses. Past evidence about suicide has been limited to post-mortem data inhibiting an understanding of which personal, psychosocial, and work environment factors predispose a nurse to suicidal behaviors. The combined study of self-report and physiologic data may help us better understand sources of stress adaptation in the search for underlying biological mechanisms associated with suicide and other suboptimal psychologic health outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: PureSomni Sleep Health Product KitSingle arm pilot sample will receive intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- currently practicing as a registered nurse in the clinical setting
- have worked continuously in the same position for at least 1 year
- read, speak, and understand English language
Key exclusion criteria (3 listed)
- >1-month sick leave in the past 3 months
- pregnancy (known physiologic stress confounder)
- other healthcare workers (e.g., physicians).
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 |
|---|---|---|
| PureSomni Sleep Health Product KitPureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs | Behavioural | Experimental |
Primary outcome
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
Time frame: Baseline: Week 1
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Baseline (Week 1). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
Time frame: Follow-up: Week 4
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 4). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
Time frame: Follow-up: Week 8
This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 8). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.
Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)]
Time frame: 8 weeks
Participants will wear the OuraRing to capture physiologic continuous heart rate variability. Heart rate variability is the variance in time between heart beats (RR intervals on an EKG) and is calculated using root mean square of successive differences between heartbeats. The middle 50% of 20-25 year olds usually have an average HRV in the 55-105 range, while 60-65 year olds tend to be between 25-45. In general, a higher heart rate variability is considered better as it indicates a more adaptable and resilient autonomic nervous system, which can respond effectively to different stressors. We calculated the mean difference between the control time period (Week1-4) and the intervention time period (Week 5-8).
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Time frame: baseline-Week 1
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Time frame: Follow up- Week 4
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
Time frame: Follow up- Week 8
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
Physiologic Sleep Data - Sleep Duration (Mean Daily Hours)
Time frame: 8 weeks
This is to measure the average amount of daily sleep (hours) over an 8 week period. The physiologic data is collected via a wearable device (OuraRing). We calculated the mean difference in sleep duration (hours) between Week 1-4 (Control time period) and Week 5-8(Intervention time period).
Number of Participants With at Least 1 Suicidal Behavior (Frequency)
Time frame: 8 Weeks
Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.
6 secondary outcomes
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
Time frame: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Time frame: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score
Time frame: Baseline- Week 1
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
Time frame: Week 8
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Time frame: Week 8
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Allison A Norful, PhD principal investigator
Columbia University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PureSomni Sleep Health Product Kit in people with Suicide and Nurse's Role, run by Columbia University 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 25 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation (time frame: Baseline: Week 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.