Nurse Suicide: Physiologic Sleep Health Promotion Trial

Stress Clinical Trial

Official title:

The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate Predisposing Factors of Suicidal Ideation in Nurses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079853
• Other study ID #: AAAU3204
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: Allison A Norful, PhD
• Phone: 12123057157
• Email: aan2139[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Nurse's Role
• Sleep
• Stress
• Suicide

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

Locations

Country	Name	City	State
United States	NewYork Presbyterian Hudson Valley Hospital	Cortlandt Manor	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline: Week 1
Primary	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	Follow-up: Week 4
Primary	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	Follow-up: Week 8
Primary	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.	Mean HRV over 8 weeks
Primary	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.	baseline-Week 1
Primary	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.	Follow up- Week 4
Primary	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.	Follow up- Week 8
Primary	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).	8 weeks
Primary	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.	8 Weeks
Secondary	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	Baseline- Week 1
Secondary	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	Baseline- Week 1
Secondary	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	Baseline- Week 1