An interventional study of PureSomni Sleep Health Product Kit in Suicide, Nurse's Role and Work Environment Adverse Effects, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
714 studies on the registry are indexed under Suicide; 184 are open to participants now.
This study's enrollment of 25 is below the median of 103 across 572 interventional studies indexed under Suicide.
Browse Suicide studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Single arm pilot sample will receive intervention
Behavioral: PureSomni Sleep Health Product Kit
PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 8 Weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 8
| Milestone | Experimental |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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.
| Participants | Experimental |
|---|---|
| Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation | 2 |
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.
| Participants | Experimental |
|---|---|
| Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation | 0 |
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.
| Participants | Experimental |
|---|---|
| Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation | 0 |
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).
| milliseconds | Experimental |
|---|---|
| Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)] | 0.846 ± 5.424 |
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
| score on a scale | Experimental |
|---|---|
| Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean) | 8.30 ± 3.91 |
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
| score on a scale | Experimental |
|---|---|
| Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean) | 6.79 ± 3.37 |
Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.
| score on a scale | Experimental |
|---|---|
| Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean) | 5.85 ± 3.03 |
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).
| Hours | Experimental |
|---|---|
| Physiologic Sleep Data - Sleep Duration (Mean Daily Hours) | 6.81 ± 0.831 |
Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.
| participants | Experimental |
|---|---|
| Number of Participants With at Least 1 Suicidal Behavior (Frequency) | 0 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score | 31.2 ± 11.72 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score | 10.84 ± 6.17 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score | 44.92 ± 7.49 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score | 29 ± 14.4 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score | 10.88 ± 5.69 |
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
| score on a scale | Experimental |
|---|---|
| Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score | 44.29 ± 9.5 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Experimental |
|---|---|
| Mean | 45.2 ± 11.6 |
| Sex: Female, Male(Participants) | Experimental |
|---|---|
| Female | 21 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Experimental |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 2 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Experimental |
|---|---|
| United States | 25 |
| Maslach Burnout Inventory (Subscale: Emotional Exhaustion) Baseline(units on a scale) | Experimental |
|---|---|
| Mean | 31.2 ± 11.72 |
| Maslach Burnout Inventory (Subscale: Depersonalization) Baseline(units on a scale) | Experimental |
|---|---|
| Mean | 10.84 ± 6.17 |
| Maslach Burnout Inventory (Subscale: Personal Accomplishment) Baseline(units on a scale) | Experimental |
|---|---|
| Mean | 44.92 ± 7.49 |
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Plan to share: No
Ran from Sep 2023 to primary completion in Sep 2024, 11 months.
Results were first posted in Nov 2024, 2 months after primary completion.
Of 353 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's 11 months is below that.
Counting every sponsor, half of 366 studies reached it within 30 months; a quarter within 14 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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