Clinical trial NCT06079853: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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).

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
timeFrame: Baseline: Week 1
measure: Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
timeFrame: Follow-up: Week 4
measure: Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation
timeFrame: Follow-up: Week 8
measure: Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)]
timeFrame: 8 weeks
measure: Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
timeFrame: baseline-Week 1
measure: Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
timeFrame: Follow up- Week 4
measure: Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)
timeFrame: Follow up- Week 8
measure: Physiologic Sleep Data - Sleep Duration (Mean Daily Hours)
timeFrame: 8 weeks
measure: Number of Participants With at Least 1 Suicidal Behavior (Frequency)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
timeFrame: Baseline- Week 1
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
timeFrame: Baseline- Week 1
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score
timeFrame: Baseline- Week 1
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score
timeFrame: Week 8
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
timeFrame: Week 8
measure: Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score
timeFrame: Week 8
Other outcomes:
Locations:
city: Cortlandt Manor
country: United States
facility: NewYork Presbyterian Hudson Valley Hospital
state: New York
Study officials:
affiliation: Columbia University School of Nursing
name: Allison A Norful, PhD
role: PRINCIPAL_INVESTIGATOR
References: