Nurse Suicide: Physiologic Sleep Health Promotion Trial
Primary Purpose
Suicide, Nurse's Role, Work Environment Adverse Effects
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PureSomni Sleep Health Product Kit
Sponsored by
About this trial
This is an interventional health services research trial for Suicide focused on measuring Suicide, Nurse, Sleep, Mental Health, Work Environment, Stress, Depression, Anxiety
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria >1-month sick leave in the past 3 months pregnancy (known physiologic stress confounder) other healthcare workers (e.g., physicians).
Sites / Locations
- NewYork Presbyterian Hudson Valley HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Single arm pilot sample will receive intervention
Outcomes
Primary Outcome Measures
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- Baseline
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- 4 weeks
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score - 8 weeks
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Physiologic Stress Response- Heart Rate Variability (group mean)
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.
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.
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.
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.
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).
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.
Secondary Outcome Measures
Burnout Screening via Maslach Burnout Inventory (Subscale 1: Burnout) - 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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06079853
Brief Title
Nurse Suicide: Physiologic Sleep Health Promotion Trial
Official Title
The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate Predisposing Factors of Suicidal Ideation in Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Single arm pilot sample will receive intervention
Intervention Type
Behavioral
Intervention Name(s)
PureSomni Sleep Health Product Kit
Intervention Description
PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- Baseline
Description
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Time Frame
Baseline: Week 1
Title
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- 4 weeks
Description
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Time Frame
Follow-up: Week 4
Title
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score - 8 weeks
Description
The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
If no ideation was endorsed on the Severity Subscale, a score of 0 is assigned for the Intensity Subscale. There are no "cut off" score for intensity. However, data that looked at ranges of scores and risk ratios for suicide behavior found a 34X increase for the 21-25 range with lower odds ratios as the score range drops. These scores are best used to help inform clinical judgment when there is uncertainty about disposition and to assess change over time.
Moderate (6-10) 11x times the risk of suicide Mod. Severe (11-15) 13x times the risk of suicide Severe (16-20) 19x times the risk of suicide Very Severe (21-25) 34x times the risk of suicide
Time Frame
Follow-up: Week 8
Title
Physiologic Stress Response- Heart Rate Variability (group mean)
Description
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.
Time Frame
Mean HRV over 8 weeks
Title
Perceived Sleep Quality via Pittsburgh Sleep Quality Index global sleep score (group mean)
Description
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
Title
Perceived Sleep Quality via Pittsburgh Sleep Quality Index global sleep score (group mean)
Description
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
Title
Perceived Sleep Quality via Pittsburgh Sleep Quality Index global sleep score (group mean)
Description
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
Title
Physiologic Sleep Data - Sleep duration (mean daily hours)
Description
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).
Time Frame
8 weeks
Title
Number of Participants with at least 1 Suicidal Behavior (frequency)
Description
Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Burnout Screening via Maslach Burnout Inventory (Subscale 1: Burnout) - Mean Composite Score
Description
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
Title
Burnout Screening via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Description
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
Title
Burnout Screening via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
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
Exclusion criteria
>1-month sick leave in the past 3 months
pregnancy (known physiologic stress confounder)
other healthcare workers (e.g., physicians).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison A Norful, PhD
Phone
12123057157
Email
aan2139@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison A Norful, PhD
Organizational Affiliation
Columbia University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork Presbyterian Hudson Valley Hospital
City
Cortlandt Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison A Norful, PhD
Phone
212-305-7157
Email
aan2139@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Allison A Norful, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Nurse Suicide: Physiologic Sleep Health Promotion Trial
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