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Completed

NCT Number: NCT06079853

Nurse Suicide: Physiologic Sleep Health Promotion Trial

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.

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Key information

Conditions

Suicide Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mental Health Wellness 1 Nurse's Role Occupational Diseases Occupational Stress Personal Satisfaction Psychological Well-Being Self-Injurious Behavior Sleep Stress Stress, Psychological Work Environment Adverse Effects

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork Presbyterian Hudson Valley Hospital

Cortlandt Manor, New York, 10567, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PureSomni Sleep Health Product Kit

Behavioral

PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

Secondary outcomes

  1. Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score

    Time frame: Baseline- Week 1

    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

  2. Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score

    Time frame: Baseline- Week 1

    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

  3. Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score

    Time frame: Baseline- Week 1

    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

  4. Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score

    Time frame: Week 8

    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

  5. Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score

    Time frame: Week 8

    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

  6. Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score

    Time frame: Week 8

    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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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