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Clinical Trials/NCT06684444
NCT06684444
Enrolling By Invitation
Phase 4

Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters

University of Arizona1 site in 1 country400 target enrollmentOctober 21, 2024

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cognitive Behavioral Therapy
Sponsor
University of Arizona
Enrollment
400
Locations
1
Primary Endpoint
PROMIS Sleep Disturbance questionnaire
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 21, 2024
End Date
July 2028
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

PROMIS Sleep Disturbance questionnaire

Time Frame: 6 assessments, 6 months apart

PROMIS measures are scored on the T-score metric. 50 is the mean score of a relevant reference population, and 10 is the standard deviation of that population. High scores mean more of the concept being measured.

Multidimensional sleep health (MSH) composite

Time Frame: 6 assessments, 6 months apart

The composite uses weighted summaries of the z-scores of four actigraphic sleep health dimensions: regularity, timing, sleep efficacy, sleep duration and two subjective sleep health dimensions: satisfaction and alertness, derived from items on the PROMIS-SD and PROMIS Sleep Related Impairment (PROMIS-SRI) scale respectively. High scores mean less of the concept being measured (i.e., worse sleep health).

Secondary Outcomes

  • PROMIS Sleep Related Impairment questionnaire(6 assessments, 6 months apart)
  • Wake time after sleep onset (WASO), min - actigraphy(6 assessments, 6 months apart)
  • Number of awakenings (NAW) - actigraphy(6 assessments, 6 months apart)

Study Sites (1)

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