Clinical trial NCT06684444: Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study
Official title: Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Cognitive Behavioral Therapy
Sleep Initiation and Maintenance Disorders
Sleep Deprivation
Sleep Disorders, Intrinsic
Keywords: CBTi
sleep deprivation
sleep disorders
firefighters
sleep health coaching
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-11-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.

Detailed description: Insufficient sleep is a major public health crisis in the United States and worldwide, disproportionately affecting shift workers and other at-risk groups. Firefighters are one such group at heightened risk for disturbed sleep. Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.

Evidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBTi) as the first-line treatment for Insomnia Disorder, and substantial evidence supports the efficacy of this therapy with comorbid conditions, including shiftwork and obstructive sleep apnea. Unfortunately, access to CBT-informed sleep health interventions remains low. Workplace wellness programs could be one way to help more firefighters receive sleep intervention.

This study will recruit 20 fire agencies in Arizona (n = 400 career firefighters) to examine whether a CBTi-informed intervention is more effective than usual care in reducing sleep disturbances or improving multidimensional sleep health. The intervention will last one year and will include telephone-administered sleep health coaching to firefighters, sleep health promotion to the agency and agency leaders, and external/internal facilitation strategies for implementation. The trial will also examine which combinations of factors are associated with successful agency implementation of the intervention. All participating agencies will receive the intervention; however, some agencies will wait longer to receive the intervention than others.

Eligibility criteria: Inclusion Criteria:

* Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.
* Must have moderate or more severe levels of sleep disturbances \[item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire\].
* Must have private access to a computer or phone for sleep health coaching.

Exclusion Criteria:

* Children younger than 18 years of age.

Primary outcomes:
measure: PROMIS Sleep Disturbance questionnaire
timeFrame: 6 assessments, 6 months apart
measure: Multidimensional sleep health (MSH) composite
timeFrame: 6 assessments, 6 months apart
Secondary outcomes:
measure: PROMIS Sleep Related Impairment questionnaire
timeFrame: 6 assessments, 6 months apart
measure: Wake time after sleep onset (WASO), min - actigraphy
timeFrame: 6 assessments, 6 months apart
measure: Number of awakenings (NAW) - actigraphy
timeFrame: 6 assessments, 6 months apart
Other outcomes:
measure: Blood pressure
timeFrame: 6 assessments, 6 months apart
measure: Heart rate
timeFrame: 6 assessments, 6 months apart
measure: Occupational health clinic assessments-1, CVD
timeFrame: 4 assessments, approximately 1 year apart
measure: Occupational health clinic assessments-2, CVD
timeFrame: 4 assessments, approximately 1 year apart
measure: Occupational health clinic assessments-3, CVD
timeFrame: 4 assessments, approximately 1 year apart
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References: